Product Quality Review (PQR)-Mohammad M Sepahi - 16 June 2024.pdf
MohammadMahdiSepahi
192 views
102 slides
Aug 02, 2024
Slide 1 of 102
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
About This Presentation
Periodic Product Quality Review; regular quality reviews of medicinal products, with the aim of confirming the consistency of the current process and the adequacy of the current specifications for both the starting materials and for the finished product, in order to highlight trends and identify pro...
Slide Content
Pharmaceutical qualitysystem(PQS)Webinars Series
PQR:Principles of Product Quality Review and Cpk and Ppk Calculations
Mohammad Mahdi Sepahi, PhD
PQS/GMP Consultant
16-June-2024
[email protected]
14:00
END
9:00
START
1
PQR:Principles of Product Quality Review and Cpk and Ppk Calculations
Mohammad Mahdi Sepahi, PhD
PQS/GMP Consultant
16-June-2024
[email protected]
14:00
END
9:00
START
1
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Guidelines
Please Contributeand Ask Questions
Please Relaxand Enjoy Yourself
Please Do Not Leave The Webinar
Please After The Break, Return On Time
Native Presentation and Video Will Be Emailed
2
Guidelines
Please Contributeand Ask Questions
Please Relaxand Enjoy Yourself
Please Do Not Leave The Webinar
Please After The Break, Return On Time
Native Presentation and Video Will Be Emailed
2
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conclusion
Summary,
Questions and Comments
Agenda
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024 3
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conclusion
Summary,
Questions and Comments
Agenda
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024 3
Reference/Guidelines
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024 4
❑AllGMPGuidelinesrefertherequirementofPQR/APQR/APR
▪CFR211.810(e)
▪ICHQ7(2.5)forAPI
▪WHOGMPTRS986-Annex-2(PP)-TRS957Annex2(API)
▪PIC/S(PE009-17(PartI(1.10))&PE009-17(PartII(2.6)))
▪EUGMPEudraLex-Volume4:Part-2GMPforAPIsandPart-1,Volume4:EUGMPforMedicinalProductsChapter1
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024 4
❑AllGMPGuidelinesrefertherequirementofPQR/APQR/APR
▪CFR211.810(e)
▪ICHQ7(2.5)forAPI
▪WHOGMPTRS986-Annex-2(PP)-TRS957Annex2(API)
▪PIC/S(PE009-17(PartI(1.10))&PE009-17(PartII(2.6)))
▪EUGMPEudraLex-Volume4:Part-2GMPforAPIsandPart-1,Volume4:EUGMPforMedicinalProductsChapter1
Objectives, Applications
and Regulations
Definition and Concepts
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024 5
and Regulations
Definition and Concepts
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024 5
Definition and Concepts
History, Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conclusion
Summary,
Questions and Comments
Qualification
What is
PQR/APR/APQR?
Who are all
responsible?
Why are we talking
about PQR?
Where will PQR be
applicable?
When will we need
to organized PQR?
Howto PreparePQR
Procedure/Report?
Product Quality Review
PQR
The what, who, why, where, when and how of PQR
Please
answer
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024 6
History, Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conclusion
Summary,
Questions and Comments
Qualification
What is
PQR/APR/APQR?
Who are all
responsible?
Why are we talking
about PQR?
Where will PQR be
applicable?
When will we need
to organized PQR?
Howto PreparePQR
Procedure/Report?
Product Quality Review
PQR
The what, who, why, where, when and how of PQR
Please
answer
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024 6
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Definitions
7
Quality
The suitability of either a drug substance or a drug product for its intended use. This term
includes such attributes as the identity, strength, and purity (ICH Q6A).
USA-FDA: Annual
Product Review (APR)
A retrospective review of the history of a drug, required by the FDA for products manufactured
in or imported into the USA, undertaken on an annual basis.
PIC/S, EU: Product
Quality Review (PQR)
Periodic Product Quality Review; regular quality reviews of medicinal products, with the aim of
confirming the consistency of the current process and the adequacy of the current
specifications for both the starting materials and for the finished product, in order to highlight
trends and identify product and process improvements. The PQR should be carried out
annually, taking into account previous review results
WHO: Product Quality
Review (PQR)
Regular, periodic or rolling quality reviews of all pharmaceutical products, including export-only
products, should be conducted with the objective of verifying the consistency of the existing
process and the appropriateness of current specifications for both starting materials and
finished product, to highlight any trends and to identify product and process improvements.
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Definitions
7
Quality
The suitability of either a drug substance or a drug product for its intended use. This term
includes such attributes as the identity, strength, and purity (ICH Q6A).
USA-FDA: Annual
Product Review (APR)
A retrospective review of the history of a drug, required by the FDA for products manufactured
in or imported into the USA, undertaken on an annual basis.
PIC/S, EU: Product
Quality Review (PQR)
Periodic Product Quality Review; regular quality reviews of medicinal products, with the aim of
confirming the consistency of the current process and the adequacy of the current
specifications for both the starting materials and for the finished product, in order to highlight
trends and identify product and process improvements. The PQR should be carried out
annually, taking into account previous review results
WHO: Product Quality
Review (PQR)
Regular, periodic or rolling quality reviews of all pharmaceutical products, including export-only
products, should be conducted with the objective of verifying the consistency of the existing
process and the appropriateness of current specifications for both starting materials and
finished product, to highlight any trends and to identify product and process improvements.
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
CFR 211.810 (e)
8PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑(e)Writtenrecordsrequiredbythispartshallbemaintainedsothatdatathereincanbeusedforevaluating,atleast
annually,thequalitystandardsofeachdrugproducttodeterminetheneedforchangesindrugproductspecificationsor
manufacturingorcontrolprocedures.Writtenproceduresshallbeestablishedandfollowedforsuchevaluationsandshall
includeprovisionsfor:
(1)Areviewofarepresentativenumberofbatches,whetherapprovedorrejected,and,whereapplicable,records
associatedwiththebatch.
(2)Areviewofcomplaints,recalls,returnedorsalvageddrugproducts,andinvestigationsconductedunder§211.192for
eachdrugproduct.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
CFR 211.810 (e)
8PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑(e)Writtenrecordsrequiredbythispartshallbemaintainedsothatdatathereincanbeusedforevaluating,atleast
annually,thequalitystandardsofeachdrugproducttodeterminetheneedforchangesindrugproductspecificationsor
manufacturingorcontrolprocedures.Writtenproceduresshallbeestablishedandfollowedforsuchevaluationsandshall
includeprovisionsfor:
(1)Areviewofarepresentativenumberofbatches,whetherapprovedorrejected,and,whereapplicable,records
associatedwiththebatch.
(2)Areviewofcomplaints,recalls,returnedorsalvageddrugproducts,andinvestigationsconductedunder§211.192for
eachdrugproduct.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
ICH Q7 (2.5) for API
9PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
2.50RegularqualityreviewsofAPIsshouldbeconductedwiththeobjectiveofverifyingtheconsistencyoftheprocess.Such
reviewsshouldnormallybeconductedanddocumentedannuallyandshouldincludeatleast:
❑Areviewofcriticalin-processcontrolandcriticalAPItestresults;
❑Areviewofallbatchesthatfailedtomeetestablishedspecification(s);
❑Areviewofallcriticaldeviationsornon-conformancesandrelatedinvestigations;
❑Areviewofanychangescarriedouttotheprocessesoranalyticalmethods;
❑Areviewofresultsofthestabilitymonitoringprogram;
❑Areviewofallquality-relatedreturns,complaintsandrecalls;and
❑Areviewofadequacyofcorrectiveactions.
2.51Theresultsofthisreviewshouldbeevaluatedandanassessmentmadeofwhethercorrectiveactionoranyrevalidation
shouldbeundertaken.Reasonsforsuchcorrectiveactionshouldbedocumented.Agreedcorrectiveactionsshouldbe
completedinatimelyandeffectivemanner.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
ICH Q7 (2.5) for API
9PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
2.50RegularqualityreviewsofAPIsshouldbeconductedwiththeobjectiveofverifyingtheconsistencyoftheprocess.Such
reviewsshouldnormallybeconductedanddocumentedannuallyandshouldincludeatleast:
❑Areviewofcriticalin-processcontrolandcriticalAPItestresults;
❑Areviewofallbatchesthatfailedtomeetestablishedspecification(s);
❑Areviewofallcriticaldeviationsornon-conformancesandrelatedinvestigations;
❑Areviewofanychangescarriedouttotheprocessesoranalyticalmethods;
❑Areviewofresultsofthestabilitymonitoringprogram;
❑Areviewofallquality-relatedreturns,complaintsandrecalls;and
❑Areviewofadequacyofcorrectiveactions.
2.51Theresultsofthisreviewshouldbeevaluatedandanassessmentmadeofwhethercorrectiveactionoranyrevalidation
shouldbeundertaken.Reasonsforsuchcorrectiveactionshouldbedocumented.Agreedcorrectiveactionsshouldbe
completedinatimelyandeffectivemanner.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
WHO GMP TRS 986-Annex-2 (PP)-TRS 957 Annex 2 (API)
10PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
1.10Regular,periodicorrollingqualityreviewsofallpharmaceuticalproducts,includingexport-onlyproducts,shouldbe
conductedwiththeobjectiveofverifyingtheconsistencyoftheexistingprocessandtheappropriatenessofcurrent
specificationsforbothstartingmaterialsandfinishedproduct,tohighlightanytrendsandtoidentifyproductandprocess
improvements.Suchreviewsshouldnormallybeconductedanddocumentedannually,takingintoaccountpreviousreviews,
andshouldincludeatleast:
a)reviewofstartingmaterialsandpackagingmaterialsusedfortheproduct,especiallythosefromnewsourcesandin
particularthereviewofsupplychaintraceabilityofactivesubstances;
b)areviewofcriticalin-processcontrols,andfinishedproductresults;
c)areviewofallbatchesthatfailedtomeetestablishedspecification(s)andtheirinvestigation;
d)areviewofallsignificantdeviationsornon-conformances,therelatedinvestigationsandtheeffectivenessofresultant
CAPAstaken;
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
WHO GMP TRS 986-Annex-2 (PP)-TRS 957 Annex 2 (API)
10PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
1.10Regular,periodicorrollingqualityreviewsofallpharmaceuticalproducts,includingexport-onlyproducts,shouldbe
conductedwiththeobjectiveofverifyingtheconsistencyoftheexistingprocessandtheappropriatenessofcurrent
specificationsforbothstartingmaterialsandfinishedproduct,tohighlightanytrendsandtoidentifyproductandprocess
improvements.Suchreviewsshouldnormallybeconductedanddocumentedannually,takingintoaccountpreviousreviews,
andshouldincludeatleast:
a)reviewofstartingmaterialsandpackagingmaterialsusedfortheproduct,especiallythosefromnewsourcesandin
particularthereviewofsupplychaintraceabilityofactivesubstances;
b)areviewofcriticalin-processcontrols,andfinishedproductresults;
c)areviewofallbatchesthatfailedtomeetestablishedspecification(s)andtheirinvestigation;
d)areviewofallsignificantdeviationsornon-conformances,therelatedinvestigationsandtheeffectivenessofresultant
CAPAstaken;
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
WHO GMP TRS 986-Annex-2 (PP)-TRS 957 Annex 2 (API)
11PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
e)areviewofallchangesmadetotheprocessesoranalyticalmethods;
f)areviewofdossiervariationssubmitted,grantedorrefused;
g)areviewoftheresultsofthestabilitymonitoringprogrammeandanyadversetrends;
h)areviewofallquality-relatedreturns,complaintsandrecallsandtheinvestigationsperformedatthetime;
i)areviewofadequacyofanyotherpreviouscorrectiveactionsonproductprocessesorequipment;
j)post-marketingcommitmentsfornewdossiersandvariationstothedossiers;
k)thequalificationstatusofrelevantequipmentandutilities,e.g.heating,ventilationandair-conditioning(HVAC),wateror
compressedgasesandareviewoftheresultsofmonitoringtheoutputofsuchequipmentandutilities;
l)areviewoftechnicalagreementstoensurethattheyareuptodate.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
WHO GMP TRS 986-Annex-2 (PP)-TRS 957 Annex 2 (API)
11PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
e)areviewofallchangesmadetotheprocessesoranalyticalmethods;
f)areviewofdossiervariationssubmitted,grantedorrefused;
g)areviewoftheresultsofthestabilitymonitoringprogrammeandanyadversetrends;
h)areviewofallquality-relatedreturns,complaintsandrecallsandtheinvestigationsperformedatthetime;
i)areviewofadequacyofanyotherpreviouscorrectiveactionsonproductprocessesorequipment;
j)post-marketingcommitmentsfornewdossiersandvariationstothedossiers;
k)thequalificationstatusofrelevantequipmentandutilities,e.g.heating,ventilationandair-conditioning(HVAC),wateror
compressedgasesandareviewoftheresultsofmonitoringtheoutputofsuchequipmentandutilities;
l)areviewoftechnicalagreementstoensurethattheyareuptodate.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
WHO GMP TRS 986-Annex-2 (PP)-TRS 957 Annex 2 (API)
12PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Themanufacturerand,wheredifferent,marketingauthorizationholder,shouldevaluatetheresultsofthereviewandan
assessmentshouldbemadeastowhetherCAPAoranyrevalidationshouldbeundertaken,underthePQS.CAPAsshould
becompletedinatimelyandeffectivemanner,accordingtodocumentedprocedures.Thereshouldbeproceduresforthe
ongoingmanagementandreviewoftheseactions,andtheeffectivenessoftheseproceduresshouldbeverifiedduringself-
inspection.Qualityreviewsmaybegroupedbyproducttype,e.g.Soliddosageforms,liquiddosageforms,orsterile
products,wherescientificallyjustified.Wherethemarketingauthorizationholderisnotthemanufacturer,thereshouldbea
technicalagreementinplacebetweenthevariouspartiesthatdefinestheirrespectiveresponsibilitiesinproducingthequality
review.Theauthorizedpersonresponsibleforfinalbatchcertification,togetherwiththemarketingauthorizationholder,
shouldensurethatthequalityreviewisperformedinatimelymannerandisaccurate.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
WHO GMP TRS 986-Annex-2 (PP)-TRS 957 Annex 2 (API)
12PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Themanufacturerand,wheredifferent,marketingauthorizationholder,shouldevaluatetheresultsofthereviewandan
assessmentshouldbemadeastowhetherCAPAoranyrevalidationshouldbeundertaken,underthePQS.CAPAsshould
becompletedinatimelyandeffectivemanner,accordingtodocumentedprocedures.Thereshouldbeproceduresforthe
ongoingmanagementandreviewoftheseactions,andtheeffectivenessoftheseproceduresshouldbeverifiedduringself-
inspection.Qualityreviewsmaybegroupedbyproducttype,e.g.Soliddosageforms,liquiddosageforms,orsterile
products,wherescientificallyjustified.Wherethemarketingauthorizationholderisnotthemanufacturer,thereshouldbea
technicalagreementinplacebetweenthevariouspartiesthatdefinestheirrespectiveresponsibilitiesinproducingthequality
review.Theauthorizedpersonresponsibleforfinalbatchcertification,togetherwiththemarketingauthorizationholder,
shouldensurethatthequalityreviewisperformedinatimelymannerandisaccurate.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
PIC/S (PE 009-17 (Part I (1.10)) & PE 009-17 (Part II (2.6))) and EU
13PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
1.10Regularperiodicorrollingqualityreviewsofallauthorisedmedicinalproducts,includingexportonlyproducts,shouldbe
conductedwiththeobjectiveofverifyingtheconsistencyoftheexistingprocess,theappropriatenessofcurrentspecifications
forbothstartingmaterialsandfinishedproduct,tohighlightanytrendsandtoidentifyproductandprocessimprovements.
Suchreviewsshouldnormallybeconductedanddocumentedannually,takingintoaccountpreviousreviews,andshould
includeatleast:
(i)Areviewofstartingmaterialsincludingpackagingmaterialsusedintheproduct,especiallythosefromnewsourcesandin
particularthereviewofsupplychaintraceabilityofactivesubstances;
(ii)Areviewofcriticalin-processcontrolsandfinishedproductresults;
(iii)Areviewofallbatchesthatfailedtomeetestablishedspecification(s)andtheirinvestigation;
(iv)Areviewofallsignificantdeviationsornon-conformances,theirrelatedinvestigations,andtheeffectivenessofresultant
correctiveandpreventiveactionstaken;
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
PIC/S (PE 009-17 (Part I (1.10)) & PE 009-17 (Part II (2.6))) and EU
13PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
1.10Regularperiodicorrollingqualityreviewsofallauthorisedmedicinalproducts,includingexportonlyproducts,shouldbe
conductedwiththeobjectiveofverifyingtheconsistencyoftheexistingprocess,theappropriatenessofcurrentspecifications
forbothstartingmaterialsandfinishedproduct,tohighlightanytrendsandtoidentifyproductandprocessimprovements.
Suchreviewsshouldnormallybeconductedanddocumentedannually,takingintoaccountpreviousreviews,andshould
includeatleast:
(i)Areviewofstartingmaterialsincludingpackagingmaterialsusedintheproduct,especiallythosefromnewsourcesandin
particularthereviewofsupplychaintraceabilityofactivesubstances;
(ii)Areviewofcriticalin-processcontrolsandfinishedproductresults;
(iii)Areviewofallbatchesthatfailedtomeetestablishedspecification(s)andtheirinvestigation;
(iv)Areviewofallsignificantdeviationsornon-conformances,theirrelatedinvestigations,andtheeffectivenessofresultant
correctiveandpreventiveactionstaken;
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
PIC/S (PE 009-17 (Part I (1.10)) & PE 009-17 (Part II (2.6))) and EU
14PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
(v)Areviewofallchangescarriedouttotheprocessesoranalyticalmethods;
(vi)AreviewofMarketingAuthorisationvariationssubmitted,grantedorrefused,includingthoseforthirdcountry(export
only)dossiers;
(vii)Areviewoftheresultsofthestabilitymonitoringprogrammeandanyadversetrends;
(viii)Areviewofallquality-relatedreturns,complaintsandrecallsandtheinvestigationsperformedatthetime;
(ix)Areviewofadequacyofanyotherpreviousproductprocessorequipmentcorrectiveactions;
(x)FornewMarketingAuthorisationsandvariationstoMarketingAuthorisations,areviewofpost-marketingcommitments;
(xi)Thequalificationstatusofrelevantequipmentandutilities,e.g.HVAC,water,compressedgases,etc;
(xii)AreviewofanycontractualarrangementsasdefinedinChapter7toensurethattheyareuptodate.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
PIC/S (PE 009-17 (Part I (1.10)) & PE 009-17 (Part II (2.6))) and EU
14PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
(v)Areviewofallchangescarriedouttotheprocessesoranalyticalmethods;
(vi)AreviewofMarketingAuthorisationvariationssubmitted,grantedorrefused,includingthoseforthirdcountry(export
only)dossiers;
(vii)Areviewoftheresultsofthestabilitymonitoringprogrammeandanyadversetrends;
(viii)Areviewofallquality-relatedreturns,complaintsandrecallsandtheinvestigationsperformedatthetime;
(ix)Areviewofadequacyofanyotherpreviousproductprocessorequipmentcorrectiveactions;
(x)FornewMarketingAuthorisationsandvariationstoMarketingAuthorisations,areviewofpost-marketingcommitments;
(xi)Thequalificationstatusofrelevantequipmentandutilities,e.g.HVAC,water,compressedgases,etc;
(xii)AreviewofanycontractualarrangementsasdefinedinChapter7toensurethattheyareuptodate.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
PIC/S (PE 009-17 (Part I (1.10)) & PE 009-17 (Part II (2.6))) and EU
15PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
1.11Themanufacturerand,wheredifferent,MarketingAuthorisationholdershouldevaluatetheresultsofthereviewandan
assessmentmadeastowhethercorrectiveandpreventiveactionoranyrevalidationshouldbeundertaken,underthe
PharmaceuticalQualitySystem.Thereshouldbemanagementproceduresfortheongoingmanagementandreviewofthese
actionsandtheeffectivenessoftheseproceduresverifiedduringself-inspection.Qualityreviewsmaybegroupedbyproduct
type,e.g.soliddosageforms,liquiddosageforms,sterileproducts,etc.wherescientificallyjustified.
WheretheMarketingAuthorisationholderisnotthemanufacturer,thereshouldbeatechnicalagreementinplacebetween
thevariouspartiesthatdefinestheirrespectiveresponsibilitiesinproducingtheproductqualityreview.TheAuthorised
PersonresponsibleforfinalbatchcertificationtogetherwiththeMarketingAuthorisationholdershouldensurethatthequality
reviewisperformedinatimelymannerandisaccurate.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
PIC/S (PE 009-17 (Part I (1.10)) & PE 009-17 (Part II (2.6))) and EU
15PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
1.11Themanufacturerand,wheredifferent,MarketingAuthorisationholdershouldevaluatetheresultsofthereviewandan
assessmentmadeastowhethercorrectiveandpreventiveactionoranyrevalidationshouldbeundertaken,underthe
PharmaceuticalQualitySystem.Thereshouldbemanagementproceduresfortheongoingmanagementandreviewofthese
actionsandtheeffectivenessoftheseproceduresverifiedduringself-inspection.Qualityreviewsmaybegroupedbyproduct
type,e.g.soliddosageforms,liquiddosageforms,sterileproducts,etc.wherescientificallyjustified.
WheretheMarketingAuthorisationholderisnotthemanufacturer,thereshouldbeatechnicalagreementinplacebetween
thevariouspartiesthatdefinestheirrespectiveresponsibilitiesinproducingtheproductqualityreview.TheAuthorised
PersonresponsibleforfinalbatchcertificationtogetherwiththeMarketingAuthorisationholdershouldensurethatthequality
reviewisperformedinatimelymannerandisaccurate.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Benefit or Use
16PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑MeetingtheRegulatoryCommitmentsandRequirements
❑Helptominimizethe00Sresultsanddeviations
❑MinimizetheriskofReworkorReprocessing
❑Decreasedowntime
❑Increaseproductivity
❑DecreasetheRiskofProductRecalls
❑Improvecommunicationbetweenproduction,engineering,qualityandregulatoryfunctions
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Benefit or Use
16PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑MeetingtheRegulatoryCommitmentsandRequirements
❑Helptominimizethe00Sresultsanddeviations
❑MinimizetheriskofReworkorReprocessing
❑Decreasedowntime
❑Increaseproductivity
❑DecreasetheRiskofProductRecalls
❑Improvecommunicationbetweenproduction,engineering,qualityandregulatoryfunctions
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Responsibilities
17PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑ResponsibilitieslieswithQA
❑EstablishanSOPwithresponsibilityandprocessofPQR
❑IndividualdepartmentshavetoprovidethedataandparticipatinginthePQRprocess.
❑Reviewsshouldnormallybeconductedanddocumented
❑TheQualityUnit,asthecentralposition,shouldrequestthisreviewandcoordinatethenecessarywork.Candevelop
format/checklisttogetinformation.
❑Production,Engineering,Maintenance,Purchase,etc.arealsoneedtobeinvolved.
❑SeniorQualityManagementmustapprovethePQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Responsibilities
17PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑ResponsibilitieslieswithQA
❑EstablishanSOPwithresponsibilityandprocessofPQR
❑IndividualdepartmentshavetoprovidethedataandparticipatinginthePQRprocess.
❑Reviewsshouldnormallybeconductedanddocumented
❑TheQualityUnit,asthecentralposition,shouldrequestthisreviewandcoordinatethenecessarywork.Candevelop
format/checklisttogetinformation.
❑Production,Engineering,Maintenance,Purchase,etc.arealsoneedtobeinvolved.
❑SeniorQualityManagementmustapprovethePQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Responsibilities
18PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑ResponsibilitieslieswithQA
❑EstablishanSOPwithresponsibilityandprocessofPQR
❑IndividualdepartmentshavetoprovidethedataandparticipatinginthePQRprocess.
❑Reviewsshouldnormallybeconductedanddocumented
❑TheQualityUnit,asthecentralposition,shouldrequestthisreviewandcoordinatethenecessarywork.Candevelop
format/checklisttogetinformation.
❑Production,Engineering,Maintenance,Purchase,etc.arealsoneedtobeinvolved.
❑SeniorQualityManagementmustapprovethePQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Responsibilities
18PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑ResponsibilitieslieswithQA
❑EstablishanSOPwithresponsibilityandprocessofPQR
❑IndividualdepartmentshavetoprovidethedataandparticipatinginthePQRprocess.
❑Reviewsshouldnormallybeconductedanddocumented
❑TheQualityUnit,asthecentralposition,shouldrequestthisreviewandcoordinatethenecessarywork.Candevelop
format/checklisttogetinformation.
❑Production,Engineering,Maintenance,Purchase,etc.arealsoneedtobeinvolved.
❑SeniorQualityManagementmustapprovethePQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
SOP for PQR
19PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Writtenproceduresshallbeestablishedanditmustbefollowed;
❑Proceduremustcoveratleastone-yearrollingperiod.Canbeoncalendaryear
❑Thereviewallproductsmanufacturedandshouldbecompletedwithin60calendardays
❑Incaseproductnotmanufacturedintheyearofreview,shallreviewstabilityandcomplaint,Recall&Returnsetc.
1.Reviewallbatchesmanufactured(accepted/rejected(destroyed)
2.Thereviewofallbatcheswhichfailtomeetspecificationandthereviewofcriticaldeviationsintheproduction,
Laboratoryfacilityetc.
3.Assessmentofdata,documentsandelectronicrecordsinthereview
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
SOP for PQR
19PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Writtenproceduresshallbeestablishedanditmustbefollowed;
❑Proceduremustcoveratleastone-yearrollingperiod.Canbeoncalendaryear
❑Thereviewallproductsmanufacturedandshouldbecompletedwithin60calendardays
❑Incaseproductnotmanufacturedintheyearofreview,shallreviewstabilityandcomplaint,Recall&Returnsetc.
1.Reviewallbatchesmanufactured(accepted/rejected(destroyed)
2.Thereviewofallbatcheswhichfailtomeetspecificationandthereviewofcriticaldeviationsintheproduction,
Laboratoryfacilityetc.
3.Assessmentofdata,documentsandelectronicrecordsinthereview
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
SOP for PQR
20PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
4.ReviewofthestartingmaterialsusedandchangeofvendorofKSM
5.ReviewoftheIn-processcontroltestresults,qualityattributesofintermediateandfinalproduct.
6.Reviewofprocessparametersandoutputoryield
7.Reviewofallqualityrelatedreturns,complaintsandrecallsandtheinvestigationsperformed
8.Reviewthestabilitydataandadversetrendsifany
9.Resultofverificationofreservesamples
10.Equipmentadditionorretired,Qualification/requalification,calibration&PM
11.Reviewofanychangescarriedoutintheprocessesequipment,specificationsoranalyticalmethods,facility,
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
SOP for PQR
20PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
4.ReviewofthestartingmaterialsusedandchangeofvendorofKSM
5.ReviewoftheIn-processcontroltestresults,qualityattributesofintermediateandfinalproduct.
6.Reviewofprocessparametersandoutputoryield
7.Reviewofallqualityrelatedreturns,complaintsandrecallsandtheinvestigationsperformed
8.Reviewthestabilitydataandadversetrendsifany
9.Resultofverificationofreservesamples
10.Equipmentadditionorretired,Qualification/requalification,calibration&PM
11.Reviewofanychangescarriedoutintheprocessesequipment,specificationsoranalyticalmethods,facility,
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
SOP for PQR
21PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
12.ReviewofactiontakenfortherecommendationofthepreviousyearPQR
13.Reviewofadequacyofcorrectiveactionsimplementedandeffectiveness
14.ReviewthecriticalutilitieslikeHVAC,water,compressedgasesoResultofEnvironmentmonitoring/Bio-burdonoWater
testresults-conductivity,TOCtrendetc.oIfitiscommonutilities,itcanbedocumentedseparately.
15.Reviewoftechnicalagreementsandensureitisupdated.
AlltheabovedetailsshallbecoveredintheSOP.Preparetrenddata,statisticalanalysiswithconclusionand
recommendation
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
SOP for PQR
21PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
12.ReviewofactiontakenfortherecommendationofthepreviousyearPQR
13.Reviewofadequacyofcorrectiveactionsimplementedandeffectiveness
14.ReviewthecriticalutilitieslikeHVAC,water,compressedgasesoResultofEnvironmentmonitoring/Bio-burdonoWater
testresults-conductivity,TOCtrendetc.oIfitiscommonutilities,itcanbedocumentedseparately.
15.Reviewoftechnicalagreementsandensureitisupdated.
AlltheabovedetailsshallbecoveredintheSOP.Preparetrenddata,statisticalanalysiswithconclusionand
recommendation
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Review and Preparation of PQR
22PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Collectthedataandtabulatetheselectedparameters,forreviewanddocumentation.Example
❑Keystartingmaterial/Criticalmaterial
❑Criticalqualityparametersoffinishedproduct/blended
❑BatchNo,testparameters,testresultofintermediates&API
❑Criticalin-processcontrols&testresults,processparameters
❑No.ofbatchesmanufactured,andcorrespondingyields
❑No.Or%ofbatchesrejected,reworkedorreprocessed
❑No.ofBatchesunderOOS,non-conformance/deviation
❑QuantityorNo.ofComplaints,returnsetc
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Review and Preparation of PQR
22PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Collectthedataandtabulatetheselectedparameters,forreviewanddocumentation.Example
❑Keystartingmaterial/Criticalmaterial
❑Criticalqualityparametersoffinishedproduct/blended
❑BatchNo,testparameters,testresultofintermediates&API
❑Criticalin-processcontrols&testresults,processparameters
❑No.ofbatchesmanufactured,andcorrespondingyields
❑No.Or%ofbatchesrejected,reworkedorreprocessed
❑No.ofBatchesunderOOS,non-conformance/deviation
❑QuantityorNo.ofComplaints,returnsetc
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Review of Documents & System {Data collection and review}
23PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑Manufacturinginstructionsandpackagingprocedures
oChangesintheprocessandvalidationstatusafterchange
❑BatchProductionRecords
oProcessparameters:actualandstandard
oIPCtestdata,deviations,Yield,Cpk,
oEquipment'schange
oEnvironmentmonitoring
❑QualityControlData
oChangestospecificationsormethods
oValidationstatusofthetestmethods
oAnalyticalInstruments&equipmentQualification,calibration
oDeviationorincident
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Review of Documents & System {Data collection and review}
23PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑Manufacturinginstructionsandpackagingprocedures
oChangesintheprocessandvalidationstatusafterchange
❑BatchProductionRecords
oProcessparameters:actualandstandard
oIPCtestdata,deviations,Yield,Cpk,
oEquipment'schange
oEnvironmentmonitoring
❑QualityControlData
oChangestospecificationsormethods
oValidationstatusofthetestmethods
oAnalyticalInstruments&equipmentQualification,calibration
oDeviationorincident
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Review of Documents & System {Data collection and review}
24PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑QualityManagementSystem:
oDeviations,OOS,Failurecauseanalysis
oCustomercomplaint,Returns,recalls
oReprocess,rework/salvageofmaterial
❑Vendorstatus:
oChangeofvendor,qualificationandapproval
oDeviations,rejectionsofrawmaterial
❑Facility:
oChangeoffacility,utility,HVAC,compressedgasesetc.
oRequalificationofHVAC,temperature,differentialpressureenvironmentmonitoring-bio-burdenanddeviationifany
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Review of Documents & System {Data collection and review}
24PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑QualityManagementSystem:
oDeviations,OOS,Failurecauseanalysis
oCustomercomplaint,Returns,recalls
oReprocess,rework/salvageofmaterial
❑Vendorstatus:
oChangeofvendor,qualificationandapproval
oDeviations,rejectionsofrawmaterial
❑Facility:
oChangeoffacility,utility,HVAC,compressedgasesetc.
oRequalificationofHVAC,temperature,differentialpressureenvironmentmonitoring-bio-burdenanddeviationifany
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Review of Documents & System {Data collection and review}
25PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑ReviewofStabilitydata/Holdtimedata
oAdversetrendifany
oChangestopackagingmaterialorProcess
❑ReviewofWatersystem:Changes,qualification,chemicalandmicrobialtrend,deviationifany
❑Reviewoftechnicalagreementswithcontactmanufacturing,testing
❑Labandserviceprovidersensureitisupdated
❑Resultofverificationofreservesamplesandreportdeteriorationifany
❑Regulatory:Issuesandannualupdaterequirementifany
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Review of Documents & System {Data collection and review}
25PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑ReviewofStabilitydata/Holdtimedata
oAdversetrendifany
oChangestopackagingmaterialorProcess
❑ReviewofWatersystem:Changes,qualification,chemicalandmicrobialtrend,deviationifany
❑Reviewoftechnicalagreementswithcontactmanufacturing,testing
❑Labandserviceprovidersensureitisupdated
❑Resultofverificationofreservesamplesandreportdeteriorationifany
❑Regulatory:Issuesandannualupdaterequirementifany
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Conclusion and Recommendations
26PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑Preparethedetailedreportforeachelementsandpresenttherequireddata,trendchart,reviewallthedata,reportthe
observationbasedonthefindings.Reporttheconclusionandrecommendationbasedontheoverallreview.
❑ObservationsRecommendationsandconclusion
❑Aconclusionstatementmustbewrittentoassessiftheproductconsistentlymeetsitsqualityattributes,andifnot,what
actionsneedtobetaken,
❑TheresultsofthePQRmustbeevaluatedandanassessmentmadewhethercorrectiveorpreventiveactionoranyre-
validationisnecessary.
❑RationaleforsuchCAPAsmustbedocumented.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Conclusion and Recommendations
26PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑Preparethedetailedreportforeachelementsandpresenttherequireddata,trendchart,reviewallthedata,reportthe
observationbasedonthefindings.Reporttheconclusionandrecommendationbasedontheoverallreview.
❑ObservationsRecommendationsandconclusion
❑Aconclusionstatementmustbewrittentoassessiftheproductconsistentlymeetsitsqualityattributes,andifnot,what
actionsneedtobetaken,
❑TheresultsofthePQRmustbeevaluatedandanassessmentmadewhethercorrectiveorpreventiveactionoranyre-
validationisnecessary.
❑RationaleforsuchCAPAsmustbedocumented.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Conclusion and Recommendations
27PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑Stateofvalidation,consistencyofprocessparameter&qualityattributes.
❑AnyspikeorOOTinthedatahavetoexplainedandjustified
❑Followingaretheexamplesforrecommendation,butnotlimitedto:
oProductprocessimprovement
oAnalyticalmethodimprovements
oRevisionofspecification
oIn-processorfinalproductspecificationreview
oRevalidation,Requalification
oProductrecallorwithdrawal
oNewpackaging
oTraining
oVendorcontrol
oCalibrationandmaintenance
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
Conclusion and Recommendations
27PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
❑Stateofvalidation,consistencyofprocessparameter&qualityattributes.
❑AnyspikeorOOTinthedatahavetoexplainedandjustified
❑Followingaretheexamplesforrecommendation,butnotlimitedto:
oProductprocessimprovement
oAnalyticalmethodimprovements
oRevisionofspecification
oIn-processorfinalproductspecificationreview
oRevalidation,Requalification
oProductrecallorwithdrawal
oNewpackaging
oTraining
oVendorcontrol
oCalibrationandmaintenance
Key Elements and Steps
for Execution of PQR
Key Elements and Steps
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024 28
for Execution of PQR
Key Elements and Steps
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024 28
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
29PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
29PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
30PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
30PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
31PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Scheduling product quality reviews
❑PQRsshouldtypicallybe:
oCarriedoutforeachproductmanufacturedinthepreviousyear;
oTakeintoaccountreviewsfrompreviousyears;and
oUseariskbasedapproach,refertoPIC/SGuidetoGMPAnnex20:QualityRiskManagement.
APQRscheduleisdocumented(typicallyannually)foreachproduct/groupofproductswithinaPQRregister.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
31PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Scheduling product quality reviews
❑PQRsshouldtypicallybe:
oCarriedoutforeachproductmanufacturedinthepreviousyear;
oTakeintoaccountreviewsfrompreviousyears;and
oUseariskbasedapproach,refertoPIC/SGuidetoGMPAnnex20:QualityRiskManagement.
APQRscheduleisdocumented(typicallyannually)foreachproduct/groupofproductswithinaPQRregister.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
32PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Grouping Products
❑PQRmaybecompletedbygroupingproductsbyaparticularcharacteristic/type.Productgroupingsmustbescientifically
justified.Forexample,productsselectedwithinagroupmustbesimilarenoughsothattheparametersbeingreviewedin
thePQRarerepresentativeofthegroup.Manufacturersshouldrevieweverybatchwithinthegrouping.Thejustification
forthegroupingsselectedmustbedocumentedinthePQRreport,oralternatively,withinthePQRprocedureif
groupings/approachwillremainthesameacrosssuccessivePQRs.
❑Important:Groupingsshouldnotbejustifiedbasedoncommercialfactors.
❑Thegroupedproductsshouldbeofthesamepharmaceuticalformcontainingthesameorverysimilaractiveingredients
andexcipients,andmanufacturedusingthesametypeofequipment.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
32PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Grouping Products
❑PQRmaybecompletedbygroupingproductsbyaparticularcharacteristic/type.Productgroupingsmustbescientifically
justified.Forexample,productsselectedwithinagroupmustbesimilarenoughsothattheparametersbeingreviewedin
thePQRarerepresentativeofthegroup.Manufacturersshouldrevieweverybatchwithinthegrouping.Thejustification
forthegroupingsselectedmustbedocumentedinthePQRreport,oralternatively,withinthePQRprocedureif
groupings/approachwillremainthesameacrosssuccessivePQRs.
❑Important:Groupingsshouldnotbejustifiedbasedoncommercialfactors.
❑Thegroupedproductsshouldbeofthesamepharmaceuticalformcontainingthesameorverysimilaractiveingredients
andexcipients,andmanufacturedusingthesametypeofequipment.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
33PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Grouping Products
❑Thenumberandnameofallfinishedproductsmanufacturedwillvaryfromyeartoyearandasnewlicensedproducts
comeontothemarket.Therefore,thenumberandnameofeachproductmanufacturedduringtheperiodofreviewforthe
PQRmustbeincludedwithinthePQRreportandwithinthePQRregister.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
33PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Grouping Products
❑Thenumberandnameofallfinishedproductsmanufacturedwillvaryfromyeartoyearandasnewlicensedproducts
comeontothemarket.Therefore,thenumberandnameofeachproductmanufacturedduringtheperiodofreviewforthe
PQRmustbeincludedwithinthePQRreportandwithinthePQRregister.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
34PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
34PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
35PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
35PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
36PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
36PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
37PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
37PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
38PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
38PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
39PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
39PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
40PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
40PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
41PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
41PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
42PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
42PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
43PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
43PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
44PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
44PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
45PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
45PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
46PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
46PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
47PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
47PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Conducting and documenting a PQR
❑PIC/SGuidetoGMP(Clause1.4)requiresthefollowingparameters(atminimum)tobeassessedwhenconductingPQR.
Statistical Process Control (SPC) and
Process Capability Study
Data Analysis and PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024 48
Process Capability Study
Data Analysis and PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024 48
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
49PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Evaluating PQR results
❑ThemanufacturermustevaluatetheresultsofthePQRtodeterminewhetheractionsarerequired,including:
oCorrectiveorpreventativeactions;
oValidationorrevalidation;and
oOthersiteorprocesschanges.
❑Processesshouldbedemonstratedtobeincontrolbydeterminingupper/lowerlimitsandtrends.Preventativeactions
mustbeimplementedforanyprocessesshowntobenotincontrolbeforedeviationsoroutofspecificationsoccur.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
49PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Evaluating PQR results
❑ThemanufacturermustevaluatetheresultsofthePQRtodeterminewhetheractionsarerequired,including:
oCorrectiveorpreventativeactions;
oValidationorrevalidation;and
oOthersiteorprocesschanges.
❑Processesshouldbedemonstratedtobeincontrolbydeterminingupper/lowerlimitsandtrends.Preventativeactions
mustbeimplementedforanyprocessesshowntobenotincontrolbeforedeviationsoroutofspecificationsoccur.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
50PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Evaluating PQR results
✓Identifyingtrends:Appropriatestatisticalanalysistechniqueshouldbeusedtoreviewthedatacollectedaspart
ofthePQR.
✓Interpretingresults:Analysismustbeinterpretedanddocumentedasthiswillassistmanufacturerstoidentify
correctiveandpreventativeactionsifrequired.Proposedactionsandconclusions,includingjustificationfornot
implementingactionswhenthePQRhasrevealedanadversetrendonproductqualitymustalsobedocumentedinthe
PQRreport.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
50PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Evaluating PQR results
✓Identifyingtrends:Appropriatestatisticalanalysistechniqueshouldbeusedtoreviewthedatacollectedaspart
ofthePQR.
✓Interpretingresults:Analysismustbeinterpretedanddocumentedasthiswillassistmanufacturerstoidentify
correctiveandpreventativeactionsifrequired.Proposedactionsandconclusions,includingjustificationfornot
implementingactionswhenthePQRhasrevealedanadversetrendonproductqualitymustalsobedocumentedinthe
PQRreport.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
51PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Basic Statistics for Data Analysis
Microsoft Excel MINITAB Statistical Software JMP® Software R (Programming Language)
Advanced
Common Data
Analysis Tools
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
51PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Basic Statistics for Data Analysis
Microsoft Excel MINITAB Statistical Software JMP® Software R (Programming Language)
Advanced
Common Data
Analysis Tools
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
52PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Basic Statistics for Data Analysis
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
52PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Basic Statistics for Data Analysis
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
53PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Basic Statistics for Data Analysis
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
53PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Basic Statistics for Data Analysis
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
54PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Basic Statistics for Data Analysis
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
54PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Basic Statistics for Data Analysis
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
55PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Basic Statistics for Data Analysis
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
55PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Basic Statistics for Data Analysis
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
56PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
56PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
57PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
مینادیمهکرگاهمهلماوعرددیلوت،لوصحمبولطموتحتلرتنک،دشابزابمهیلماوعرگیددننامناسونقربهکناوتیمناهنآارثتبادرک
ثعابرییغتردتاصخشمیفیکواییمکتادیلوتدنوشیم.هبکمکیاهرادومن،لرتنکیعسدوشیمیریذپرییغتطوبرمهبیویاهیگژیفیکو
یمکتلاوصحمهبودشخبلماوعلباقریغلرتنکولماوعلباقلرتنککیکفتدوش.لاومعمضرفربنیاتساهکلماوعلباقریغکلرتن(یاهاطخ
یفداصت)،یارادعیزوتلامرندنتسهوهبناونعکیهدیدپیسناشویلامتحاردرظنهتفرگدنوشیم.نیاربانبراظتنادوریمهکعلماولباقریغ
یلرتنکهکثعابتارییغتردتاصخشملوصحمدناهدشزانیناوقیفداصتیوریپدننک.رگاتارییغتهدهاشمهدشجراخزاهدودحمانینیناوق
،دشابصخشمدوشیمهکیلماعیفداصتریغرددنیآرفدیلوتتلاخدهدرکهکدیابییاسانشوفذحدوش.یاربرهریغتمیمکهکبدیاتیفیکنآ
لرتنکدوشودرتماراپنیگنایموتارییغت(یگدنکارپ)درومیسرربرارقدریگیم.یاهرادومنلرتنکیرامآدنیآرفSPC(StatisticalProcess
Control)یاربصیخشتهکنیالاقتناردناکم(نیگنایم)واییگدنکارپ(سنایراو)عیزوتریغتم،یمکشیبزانآیزیچتساکههبفداصتتبسن
هداددوشیمای،هنلمعدننکیم.عقاوردنیااهرادومنفشکردتافارحناابلیلدهبامکمکدننکیم.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
57PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
مینادیمهکرگاهمهلماوعرددیلوت،لوصحمبولطموتحتلرتنک،دشابزابمهیلماوعرگیددننامناسونقربهکناوتیمناهنآارثتبادرک
ثعابرییغتردتاصخشمیفیکواییمکتادیلوتدنوشیم.هبکمکیاهرادومن،لرتنکیعسدوشیمیریذپرییغتطوبرمهبیویاهیگژیفیکو
یمکتلاوصحمهبودشخبلماوعلباقریغلرتنکولماوعلباقلرتنککیکفتدوش.لاومعمضرفربنیاتساهکلماوعلباقریغکلرتن(یاهاطخ
یفداصت)،یارادعیزوتلامرندنتسهوهبناونعکیهدیدپیسناشویلامتحاردرظنهتفرگدنوشیم.نیاربانبراظتنادوریمهکعلماولباقریغ
یلرتنکهکثعابتارییغتردتاصخشملوصحمدناهدشزانیناوقیفداصتیوریپدننک.رگاتارییغتهدهاشمهدشجراخزاهدودحمانینیناوق
،دشابصخشمدوشیمهکیلماعیفداصتریغرددنیآرفدیلوتتلاخدهدرکهکدیابییاسانشوفذحدوش.یاربرهریغتمیمکهکبدیاتیفیکنآ
لرتنکدوشودرتماراپنیگنایموتارییغت(یگدنکارپ)درومیسرربرارقدریگیم.یاهرادومنلرتنکیرامآدنیآرفSPC(StatisticalProcess
Control)یاربصیخشتهکنیالاقتناردناکم(نیگنایم)واییگدنکارپ(سنایراو)عیزوتریغتم،یمکشیبزانآیزیچتساکههبفداصتتبسن
هداددوشیمای،هنلمعدننکیم.عقاوردنیااهرادومنفشکردتافارحناابلیلدهبامکمکدننکیم.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
58PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
رادومن یلرتنک اب یاه نارک یتابساحم
روطنامههکدینیبیمطخیزکرمنامهدروآربنیگنایمعیزوتلامرنتسا.نینچمهیارب
هبساحمUCLوLCLزاسنایراواههدادهبروظنمدروآربرتماراپیگدنکارپعیزوتلامرنتساهداف
هدشتسا.زاییاجنآهکشیبزا۹۹٪،اههدادردهلصاف۳فارحنادرادناتسازانیگنایمرارق
،دنرادراظتنامیرادهکردرادومنلرتنکیفیکمیسرتهدشهمهطاقنردهلصافنیبUCLوLCL
رارقدنریگ.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
58PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
رادومن یلرتنک اب یاه نارک یتابساحم
روطنامههکدینیبیمطخیزکرمنامهدروآربنیگنایمعیزوتلامرنتسا.نینچمهیارب
هبساحمUCLوLCLزاسنایراواههدادهبروظنمدروآربرتماراپیگدنکارپعیزوتلامرنتساهداف
هدشتسا.زاییاجنآهکشیبزا۹۹٪،اههدادردهلصاف۳فارحنادرادناتسازانیگنایمرارق
،دنرادراظتنامیرادهکردرادومنلرتنکیفیکمیسرتهدشهمهطاقنردهلصافنیبUCLوLCL
رارقدنریگ.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
59PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
ابهدهاشمیاهطقنجراخزانیادودحهبجراخزالرتنکندوبدنیآرفدیلوتلوصحمبیپهدرو
دیابهبلابندیلماعیفداصتریغمیشابهکدنیآرفدیلوتارزادنوریداع(ابلماعتیفداص)جراخ
هدرکتسا.
ردریوصتصخشمتساهکردهطقن۱۱(هنومنهرامش۱۱اینامز۱۱)کیهنومنابیاهیگژیو
لومعمریغرددنیآرفدیلوتدوجودراد.تلعنیارمانکممتساهبرطاخلاکشاردداومیلواهای
هابتشاروتارپارددنیآرفدیلوتایجراخندشهاگتسدزادرادناتسادشاب.نیالماوعابدییسررب
هدشوزادنیارفدیلوتجراخدنوش.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
59PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
ابهدهاشمیاهطقنجراخزانیادودحهبجراخزالرتنکندوبدنیآرفدیلوتلوصحمبیپهدرو
دیابهبلابندیلماعیفداصتریغمیشابهکدنیآرفدیلوتارزادنوریداع(ابلماعتیفداص)جراخ
هدرکتسا.
ردریوصتصخشمتساهکردهطقن۱۱(هنومنهرامش۱۱اینامز۱۱)کیهنومنابیاهیگژیو
لومعمریغرددنیآرفدیلوتدوجودراد.تلعنیارمانکممتساهبرطاخلاکشاردداومیلواهای
هابتشاروتارپارددنیآرفدیلوتایجراخندشهاگتسدزادرادناتسادشاب.نیالماوعابدییسررب
هدشوزادنیارفدیلوتجراخدنوش.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
60PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
رادومن یلرتنک اب یاه نارک رایعم
نکممتسایاربراومن،لرتنکییاهنارکیاربیگژیولوصحمطسوتتکرشردرظنگهتفرهدش
دشاب.ردنیاتلاحاهنآارابمان«نارکیلاابرایعم»(UpperStandardLimit)و
«نارکنییاپرایعم»(LowerStandardLimit)دنمانیم.
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
60PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
رادومن یلرتنک اب یاه نارک رایعم
نکممتسایاربراومن،لرتنکییاهنارکیاربیگژیولوصحمطسوتتکرشردرظنگهتفرهدش
دشاب.ردنیاتلاحاهنآارابمان«نارکیلاابرایعم»(UpperStandardLimit)و
«نارکنییاپرایعم»(LowerStandardLimit)دنمانیم.
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
61PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
61PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
62PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
62PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
63PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
63PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
64PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
64PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
65PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
65PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
66PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
66PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Control Charts
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
67PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
67PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
68PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
68PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
69PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
69PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
70PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
❑ApplicationoftheProcessCapabilitystudy
oThepurposeofaProcessCapabilitystudy,istodetermineiftheprocessiscapableofconsistentlymeetingthe
customer'sspecifications,andtotakecorrectiveactionsifnecessary.
❑RequirementsofaProcessCapabilitystudy
oStableprocess.
✓Therearenospecialcauses.Itisverifiedwiththecontrolchartofaveragesandranges,averagesandsigma'sorI-
MR.ThisappliestoindicesCpandCpk.Stabilityistoensurethattheprocessremainscenteredonthenominal
productspecificationorprocessobjectiveandthattheprocessvariationremainswithincontrollimits.IndicesPpand
Ppktheydonotrequiretheprocesstobestable.
❑Individualdatanormality.
oTheindividualdataisnormallydistributed.Normalityisarequirementforestimatingdefectsinpartspermillionppm.
❑Capableprocess.
oCpkandPpkmeetcustomerrequirements(1.67fortheautomotivesectorand1.33forthenonautomotivesector).
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
70PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
❑ApplicationoftheProcessCapabilitystudy
oThepurposeofaProcessCapabilitystudy,istodetermineiftheprocessiscapableofconsistentlymeetingthe
customer'sspecifications,andtotakecorrectiveactionsifnecessary.
❑RequirementsofaProcessCapabilitystudy
oStableprocess.
✓Therearenospecialcauses.Itisverifiedwiththecontrolchartofaveragesandranges,averagesandsigma'sorI-
MR.ThisappliestoindicesCpandCpk.Stabilityistoensurethattheprocessremainscenteredonthenominal
productspecificationorprocessobjectiveandthattheprocessvariationremainswithincontrollimits.IndicesPpand
Ppktheydonotrequiretheprocesstobestable.
❑Individualdatanormality.
oTheindividualdataisnormallydistributed.Normalityisarequirementforestimatingdefectsinpartspermillionppm.
❑Capableprocess.
oCpkandPpkmeetcustomerrequirements(1.67fortheautomotivesectorand1.33forthenonautomotivesector).
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
71PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
71PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
72PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
72PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
73PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
73PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
74PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
74PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
75PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
75PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
76PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
76PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
77PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
77PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
78PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
78PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
79PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
79PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Process Capability Study Methodology
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
80PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Xbar-R Process Capability Study with Minitab
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
80PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Xbar-R Process Capability Study with Minitab
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
81PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Xbar-R Process Capability Study with Minitab
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
81PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Xbar-R Process Capability Study with Minitab
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
82PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Xbar-R Process Capability Study with Minitab
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
82PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Xbar-R Process Capability Study with Minitab
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
83PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Xbar-R Process Capability Study with Minitab
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
83PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Xbar-R Process Capability Study with Minitab
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
84PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
I-MR Process Capability Study with Minitab
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
84PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
I-MR Process Capability Study with Minitab
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
85PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
I-MR Process Capability Study with Minitab
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
85PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
I-MR Process Capability Study with Minitab
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
86PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
I-MR Process Capability Study with Minitab
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
86PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
I-MR Process Capability Study with Minitab
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
87PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
I-MR Process Capability Study with Minitab
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
Conclusion
Summary,
Questions and Comments
87PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Data Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
I-MR Process Capability Study with Minitab
88
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
❑TheAPQRreportshouldmentiontheproductname,year,anduniquePQRnumber,alongwiththenameofthe
manufacturer.Thedata/informationinPQRcanberepresentedwiththehelpoftables,graphs,flowcharts,appropriate
statistics,etc.BelowisanexampleofanoutlineofanPQRReport:
oObjective
oIntroduction
oProductdetails
oProcessflow
oReviewofmanufacturing-relatedinformation
oBatch
▪Stagewiseyield
▪Rejections
▪Reworking
oReviewofcriticalqualityparameters
oIn-processandintermediatetestingresults
oReviewoffinishedproducttestingresults
oOutofspecification
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
❑TheAPQRreportshouldmentiontheproductname,year,anduniquePQRnumber,alongwiththenameofthe
manufacturer.Thedata/informationinPQRcanberepresentedwiththehelpoftables,graphs,flowcharts,appropriate
statistics,etc.BelowisanexampleofanoutlineofanPQRReport:
oObjective
oIntroduction
oProductdetails
oProcessflow
oReviewofmanufacturing-relatedinformation
oBatch
▪Stagewiseyield
▪Rejections
▪Reworking
oReviewofcriticalqualityparameters
oIn-processandintermediatetestingresults
oReviewoffinishedproducttestingresults
oOutofspecification
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
89
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
oReviewof:
oEvents
oChanges
oMarketcomplaints
oControlsamples
oRecallandreturns
oStabilitydata
oValidationandqualificationstatus
oPost-marketingcommitments
oQualityofAPIs,keyrawmaterials,andkeypackingmaterials
oTechnicalagreement
oStatisticalevaluationofthedata
oReviewofstatusagainstpreviousPQR
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
oReviewof:
oEvents
oChanges
oMarketcomplaints
oControlsamples
oRecallandreturns
oStabilitydata
oValidationandqualificationstatus
oPost-marketingcommitments
oQualityofAPIs,keyrawmaterials,andkeypackingmaterials
oTechnicalagreement
oStatisticalevaluationofthedata
oReviewofstatusagainstpreviousPQR
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
90
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
oConclusion
oRecommendations
oAbbreviations
oAnnexures
oApproval
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
oConclusion
oRecommendations
oAbbreviations
oAnnexures
oApproval
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
91
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
92
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
93
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
94
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
95
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
96
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
97
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
98
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
99
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
100
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
101
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Definition and Concepts
Objectives, Applications
and Regulations
Key Elements and Steps
Key Elements and Steps
for Execution of PQR
ConclusionData Analysis and PQR Report
Statistical process control (SPC) and
Process Capability Study
Summary,
Questions and Comments
PQR Report
PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Thank You
Questions and comments?
؛مینک راختفا نامروشک دوجو هب هک تسا مهم
هک تسا نیا نآ زا رتمهم یلو:
”مینک یراک “دنک راختفا نامدوجو هب نامروشک…
102PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Questions and comments?
؛مینک راختفا نامروشک دوجو هب هک تسا مهم
هک تسا نیا نآ زا رتمهم یلو:
”مینک یراک “دنک راختفا نامدوجو هب نامروشک…
102PQR: Principles of Product Quality Review and Cpk and Ppk Calculations, Mohammad M. Sepahi, PhD –June, 2024
Categories
HealthcareDownload
Download Slideshow Get the original presentation fileQuick Actions
Statistics
- Views 192
- Slides 102
- Age 490 days
Related Slideshows
36
Clinical approach Dyspnoea A simple and practical approach.pptx
ShajahanPS
26 views
238
Cancer Awareness therapy for public by Dr Kanhu Charan Patro
kanhucpatro
26 views
41
Prof Satyadas Memorial oration Kozhikode.pptx
ShajahanPS
21 views
26
Viral Conjunctivitis and it;s managment.pptx
ZaidAzhar
35 views
30
Essential Thrombocythemia 15 Years of Experience at the Hematology Department, Algies, Algeria.pdf
sbelakehal
30 views
10
Hypertension sign symptoms cmdt style with regime
androiddabest
31 views