documentation in pharmaceutical industry.pdf

documentation in pharmaceutical industry

1. Documentation In
Pharmaceutical Industry
By Arunima Nag
Assistant professor in pharmaceutics
Bengal school of Technology
(College of pharmacy)

2. Introduction to
Documentation in the
Pharmaceutical Industry
Documentationinthepharmaceuticalindustryplaysacrucialrolein
maintainingquality,compliance,andsafetystandards.It
encompassesstandardoperatingprocedures(SOP),qualityaudits,
reviewofqualitydocumentation,andthegenerationofvariousreports
anddistributionrecords.
Aa

3. Document
Definition:
Methodofpreparingawrittenmaterial,whichdescribestheprocessintermsof
specifications,instructionsetc.
TheD&CActunderconditionsofgrantinglicenseandscheduleMrequire
manufacturerofdrugstomaintainvariousrecords.
Importanceofdocumentation:
•Providesnecessaryworkingdetails
•Reducestheriskofmistake
•Helpsindecreasingbatchtobatchvariation
•Consideredasthehistoryofbatchoperations

4. Types of Documents
▪Commitmentdocument:Relationshipbetweenindustryandtheregulatory
authorities.
•Directivedocument:Relationshipbetweenmanagementandemployee.
•Recorddocument:Relationshipbetweentheemployeeandtheworkthey
perform.

5. Master Formula Records (MFR)
Writtenprocedurethatgivethecompletedescriptionofallaspectsof
manufacture,packingandcontrolwithaninspectiontoensurepurity,identity,
qualityandstrengthofeachdosageunitthroughitsshelflife.
Includesallthematerialsusedinanybatchmanufacturingandstepbystep
processofmanufacturing.

6. The Master Formula Include:
a)Thenameoftheproducttogetherwithproductreferencecoderelatingtoitsspecifications.
b)Thepatentorproprietarynameoftheproductalongwiththegenericname,adescriptionof
dosageform,strength,compositionoftheproductandbatchsize.
c)Astatementoftheprocessinglocationandtheprincipalequipmenttobeused.
d)Name,quantityandreferencenumberofallstartingmaterialstobeused.
e)Astatementofexpectedfinalyieldwiththeacceptablelimitsandofrelevantintermediateyields,
whereapplicable.
f)Themethodsorreferenceofthemethodstobeusedforpreparingthecriticalequipment
includingcleaning,assembling,calibrating,sterilizing.
g)Detailedstepwiseprocessinginstructionsandthetimetakenforeachstep

7. TypesofMasterFormulaRecords(MFR):
➢Themasterformularecordsgivesproportionofingredientsinthe
formulation.
1.Masterbatchformularecords:
Specifyabsoluteamountsofspecificpotentingredientsandexcipientsina
batch.

8. 2. Master production and control
records:
•Detailedwritteninstructionsincludingalloperationsstartingfrom
dispensingofrawmaterialstillfinishingofbulkproductsand
packagingoperationoftheparticularproduct.
•Itincludesbatchsize,dateofmanufactureandfullsignatureby1st
personandfurtherindependentlychecked,datedandsignedby2nd
person.

9. Preparation of master formula :
•Master formula can be prepared by competent technical staff.
•It should be reviewed by the head of production, QC department and
R & D department

10. Distribution records
Writtenproceduresshallbeestablishedandfollowed,describingthedistributionofdrugproductsInclude:
1.Aprocedurewherebytheoldestapprovedstockofadrugproductisdistributedfirst
2.Asystembywhichthedistributionofeachlotofdrugproductcanbereadilydeterminedtofacilitateitsrecallif
necessary.
Distributionrecordsmustbeconstructedandproceduresestablishedtofacilitaterecallofdefectiveproduct.
Allrecordsshouldbeindexedbyeitherthemanufacturingbatch-lotnumberofthepackagingcontrolnumberasa
meansofaccountability.
Itshallcontains:
▪Nameandstrengthoftheproduct
▪Descriptionofdosageform
▪Nameandaddressoftheconsigner
▪Dateandqtyshipped
▪Lotandcontrolnumberofthedrug

11. WHOguidelinesfordistributionrecords:
•Writteninstrumentsandrecordsshouldbeavailable.
•Procedureshouldbeestablishedandmaintained.
•Thetitle,nameandpurposeofeachdocumentshouldbeclearlystated.
•Alldocumentsshouldbecompleted,approved,signedaddatedbyan
appropriateauthorizedpersons.
•Inthecaseoftemperature-sensitivitypharmaceuticalproducts,records
ofinvestigationsandactionsshouldberetainedforatleastoneyear
aftertheexpirydateoftheproduct.

12. Standard Operating Procedures (SOPs)
Definition:
•Standard Operating Procedures (SOPs) are step-by-step instructions that outline how
tasks should be performed to ensure compliance with industry standards and regulations.
Purpose:
•SOPs help maintain consistency, reduce errors, and ensure that all employees understand
and adhere to established processes.
Components:
•SOPs typically include a title, scope, purpose, responsibilities, procedures, and references
for guidance.

13. Quality audit documentation
Evidence
Collection
Gathering and
documenting evidence of
compliance during the
audit process.
Comprehensive
Reporting
Creation of detailed reports
documenting findings and
recommendations for
improvement.
Audit Trail
Documentation
Recording and maintaining
a comprehensive audit trail
for transparency and
accountability.

14. QualityAudit
QualityAuditisdefinedasasystematicandindependent
examinationtodeterminewhetherqualityactivitiesandrelated
resultscomplywithplannedarrangements,andwhetherthese
arrangementsareimplementedeffectivelyandaresuitableto
achieveobjectives

15. Types Of Quality Audit
The quality audit system mainly classified in following different categories:-
1. Internal Audit
2. External Audit
3. Second Party Audits
4. Third Party Audits
5. Process Audits
6. Product Audits
7. System Audits

16. Internal Audit
▪Ensurethatanorganizationismeetingitsownqualitystandardsor
contractuallyrequiredstandards.(calledafirstpartyaudit).
Done byauditorswho workforthecompany.
▪They may also be hired by the company to audit its own functions.
▪Auditorsmustbeindependentofthefunctiontheyareauditing.
(thistypeauditbycompanyemployees,consultantsand
contactors)

17. Purpose of Internal audit
1. To ensure that adequate Quality systems are maintained.
2. To ensure compliance with the C-GMP's and firms standard
operating procedure.
3. To achieve consistency between manufacturing and testing facilities.
4. To identify problems internally and Correct problems prior to a FDA
inspection.

18. External Audits
❑External auditors are separate from the company.
❑They may be hired by a supplier or customer to ensure that the audited
company meets their quality standards.
❑They may be audited by the government to verify that they meet military
specifications.
❑External audits can be done by quality consultants specializing in the quality
standards for those organizations.

19. Purpose of External Audit
-Confidence in the partnership arrangement.
-Ensuring that requirements are understood.
-Reducing the risk of failure.
-Carried out by company on its vendors. No legal requirement to
conduct the audit.
-External audit have experience of GMP as well as regularly audited
by their certification body

20. OTHER TYPES OF QUALITY AUDIT
•Second Party Audits-
External audits done by a company that has a contract with the
audited firm is called a second party audit.
• Third Party Audits-
External quality audits done by an organization that has no
contract with the company it is auditing is called a third party
audit.
• Process Audits-
A process audit verifies that a documented process meets
quality standards. This process could be a manufacturing
process or service process.

21. OTHER TYPES OF QUALITY AUDIT
•ProductAudits-
A product quality audit verifies that a physical product meets
design specifications and other quality measurements,
measuring physical dimensions, product testing, or destructive
testing, checking the calibration and test equipment used to
verify that the product meets quality standards.
•System Audits-
It is a review of how quality standards are measured and met by
the company. It verifies the procedures used to measure the
quality of the product, how defects are recorded, and how the
company ensures that failed product is not passed.

22. QUALITY REVIEW
•Qualityreviewisplannedanddocumentedinspectionsofareviewsystemi.e.,“Processof
reviewingallspecificationsatallin-processcheckpointsaremetandalldocumentationwith
signaturesareincorporatedinBatchrecord.”
•Thereviewitemmaybeproduct,agroupofrelatedproductsorapartofaproduct.
•Theearlieranerrorisidentifiedthelesscostlyaretheimplicationsandthepenaltyfor
failingtoconductadequatereviews.
•TheUSFoodandDrugAdministrationproposedtherequirementin13February1976rewriting
oftheGMPs.Thepurposewastoprovidereliableprocedureforadrugmanufacturertoreview
thequalitystandard.
•QualityReviewwaspublishedinSeptember1978finalcurrentGMP's(cGMP)regulationfor
drugproductandbecameeffectiveon28March’1979.

23. PRINCIPLE:
•QRstudiesindicatetheproductiswithinthespecifiedlimits.
•QRalldocumentstobesuretherearenolooseendsandalso
examinestestingdatatoconfirmthattheproductmeets
specifications.
•Ifthereissignificantproblemwiththeproduct,GMPsrequire
theQCgrouptorejecttheproductandinvestigate.

24. OBJECTIVES:
1. Product Specification.
2. Identification of improvement.
3. High Lightening trends.
4. Appropriateness of starting material requirement
specifications.

25. Specific procedures tobe checked:
1. Foreign matter in production area
2. Correct amounts of correct ingredients and their correct addition
3. Separation of one lot from others
4. Maintenance of specific storage conditions
5. Cleaning of containers and equipments before use and after
fourth cycle
6. Covering of equipments in production
7. Storing production equipments on rack

26. Specific procedures tobe checked:
8. Personnel ready for task
9. Production meeting with specifications
10. Clean production area
11. Safety procedures
12. Dust control equipments
13. Supplying sealed containers until production begins and removed after
emptying
14. Sterile manufacturing guidelines are followed

27. Review of records:
MaterialRecords
Production
records
In process
records
Laboratory
records
Stability testing
of Finished
products

28. PHASES IN QR:
QR should be seen as a 3-Phase process
➢Phase-1-----------Preparation
➢Phase-2-----------Review meeting
➢Phase-3-----------Follow up

29. PHASES IN QR:
PHASE-1
• It is the responsibility of the chairman and presenter to organize
the Q.R and notify all reviewers invited.
• Invitation and copies of the products being reviewed should be
issued, allowing sufficient time for each reviewer to compile an
error list.

30. PHASES IN QR:
PHASE-2:
•Errorlistandcopiesofannotatedproductsshouldbebroughttothemeetingby
eachreviewer.
•Duringthereviewmeetingtheemphasisshouldbeonerrordetection,inline
withthecriteria,andonlylimiteddiscussionofcorrectiveactionshouldoccur.
•Itisimportantthat'personalities'and'politics'arekeptoutofthereview.
Forreviewsthatare'complete'theactionlisttasksareallocatedalongwith
designatedreviewers,toverifythattheworkisdone.
• A project exception report should be raised for any errors detected in non-review
items.

31. PHASES IN QR:
PHASE -3:
•Followupperiodduringwhichtheerrorsidentifiedatthereview
thatwerecommittedtofollowupactionlistarerectifiedand
signedoff.
•Attheendofthefollowupperiod'whichistypicallyrestrictedto
oneweek,thefollowupactionlistshouldbesignedoffbythe
chairman.

32. 4M CONCEPT
✓Man
✓Machinery
✓Method
✓Material

33. Quality Documentation Requirements
Inthepharmaceuticalindustry,qualitydocumentationrequirementsarecriticalfor
maintainingcompliancewithregulationsandensuringthesafetyandefficacyof
products.Documentationmustbecomprehensive,accurate,andup-to-datetosupport
qualityassuranceprocesses.
Qualitydocumentationincludesbatchrecords,testresults,stabilitydata,and
validationdocumentation.ItmustadheretoGoodManufacturingPractices(GMP)and
otherrelevantstandardstodemonstrateproductqualityandconsistency.

34. Reports and documents in the pharmaceutical
pharmaceutical industry
Research Reports
Comprehensive reports
detailingfindingsfrom
pharmaceutical research
studies,includingefficacy,
safety,andpotentialimpacts
ontheindustry.
Manufacturing
Documentation
Detailedrecordsofthe
pharmaceutical
manufacturing process,
includingbatchrecords,
packaginginformation,and
qualitycontroldocuments.
Regulatory Compliance
Documents
Documented evidenceof
compliancewithregulatory
requirementstoensurethe
safety,efficacy,andqualityof
pharmaceuticalproducts.

35. Distribution record documentation
Accurate Record
Keeping
It is essential to maintain
precise records of the
distribution process,
including batch numbers,
expiration dates, and
destinations.
Compliance with
Regulations
Distribution records must
adhere to strict regulatory
standards to ensure the
safety and quality of
pharmaceutical products
throughout the supply chain.
Traceability and
Accountability
Documentation enables
traceability, allowing for swift
identification and recall of
products in case of quality
issues or safety concerns.

36. Importance of Accurate and Complete
Complete Documentation
Regulatory Compliance
Accurate documentation ensures
compliance with regulatory
standards, which is vital for
pharmaceutical operations.
Patient Safety
Complete documentation directly
impacts patient safety, ensuring the
right medications reach the right
patients.
Quality Assurance
It is crucial for maintaining the quality and efficacy of pharmaceutical products
throughout their lifecycle.

37. Challenges in maintaining documentation in the
pharmaceutical industry
1
Regulatory Compliance
Adhering to constantly evolving regulations
2
Data Accuracy
Ensuring precise and error-free information
3
Document Security
Protecting sensitive information from
unauthorized access

38. Best Practices for Effective Documentation
Management
Organization
Establish a systematic
filing and naming
convention for
documents to ensure
easy retrieval and
tracking.
Collaboration
Encourage cross-
functional
collaboration to
ensure input from all
relevant stakeholders
for comprehensive
documentation.
Security
Implement strict
access controls and
encryption to
safeguard sensitive
information
contained in
documentation.
Regular Audits
Conduct regular
audits to ensure
compliance with
documentation
standards and
identify areas for
improvement.

39. Thank You.