ASEAN-TMHS-GMP-Training-–-Chapter-5-Documentation-FD.pdf

documentation requirements

1. Prepared by:
Approved by:
ASEAN TMHS GMP Task Force
30 November 2016
Endorsed by:
ASEAN TMHS Product Working Group
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements
(TM/HS)
CHAPTER 5 -DOCUMENTATION
Brunei Darussalam and Lao PDR
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2. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
ACKNOWLEDGEMENT
We would like to thank the following review team for their
input to this training module.
2
Muhammad Lukmani Ibrahim
Chair of ASEAN GMP
TF
Quitevis, LudivinaFama
Co-Chair of ASEAN
GMP TF
Mega Valentine ASEAN Secretariat
HasmilawatyMohammad TaibBrunei Darussalam
Jamilah Metusin Brunei Darussalam
HeanKimseat Cambodia
SomSamnang Cambodia
KristianaHaryati Indonesia
WidiastutiAdiputra Indonesia
BounleuaneDouangdeuane Lao PDR
SolivanhSengchanh Lao PDR
Sivong Sengaloundeth Lao PDR
Mohd Nasrul Mohamad Noor Malaysia
SharifahMasturaAhmad Fuad Malaysia
ThiriKyawSoe Myanmar
WahWahAung Myanmar
Mary Angeline V. FranciscoPhilippines
Ms. RochelAverionFrancisco Philippines
OngHaiAnn, Terrance Singapore
PinpongIntarapanich Thailand
ThidaThaveerit Thailand
Lam Quoc Hung Vietnam
Luu Duc Du Vietnam
Mak Sum Shing, Andrew AAHSA
Tamotsu Iwai AAHSA
Robles, Frances Evelyn AATMI

3. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
OUTLINE
•Objective
•Purpose
•Principle
•GeneralGuidelines
•QualityControlDocuments
•Specifications
•ProductionDocuments
•PackagingInstructions
•BatchManufacturingRecords:
–Processing
–Packaging
•StandardOperatingProceduresandRecords
•An example of Document Format
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4. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
OBJECTIVE
•Anessentialelementofqualityassuranceisgood
documentationpractices.
•Thesystemofdocumentationdevisedoradoptedshouldhave
asitsmainobjectivetoestablish,monitor,andrecord
“quality”forallaspectsoftheproduction,qualitycontroland
qualityassurance.
•Recordprovidesevidenceofworkdone.
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5. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
PURPOSE
5
•Clearlywrittendocumentationpreventserrorsthatmayarise
inoralorcasuallywrittencommunication
•Itprovidesassurancethatqualityrelatedactivitiesarecarried
outexactlythewaytheyhavebeenplannedandapproved
•Theachievementofconformityandqualityimprovement
•Purposeofdocumentation:
•Toensurethattherearespecificationsforallmaterialsand
methodsofmanufactureandcontrol
•Employeesknowwhattodo
•Responsibilitiesandauthoritiesareidentified
•Ensurethatauthorizedpersonshaveallinformationnecessary
forrelease
•Provideaudittrail
•Formsthebasisforimprovement.

6. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
PRINCIPLE
•Gooddocumentationconstitutesanessentialpartofthequality
assurancesystemandshouldexistforallaspectsofGMP.
•Clearlywrittendocumentationpreventserrorsfromspoken
communicationandpermitstracingofbatchhistoryoftheproduct,
frompurchasingofstartingmaterialstothedistributionoffinished
products.
•Itshallbeabletorecordexecutedactivitiesformaintenance,storage,
qualitycontrol,distributionandotherspecificmatterslinkedtoGMP.
•Formanufacturingactivities,adocumentationsystemmustbe
prepared.
•Thesystemconsistingofmanufacturingformulaeandinstructions,
specifications,proceduresandrecordsmustbefreefromerrorsand
clearlyestablished.
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7. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
GOOD DOCUMENTATION PRACTICE
GENERAL GUIDELINES
•Thesystemofdocumentationshallbe:
–abletorecordthecompletehistoryofeachbatch.
–adequatetopermitinvestigationandtracingofanydefectiveproducts.
•Documentsshallcontainallnecessaryinformation,tobekeptupto
dateandanyamendmentshallbeperformedbyfollowingproper
documentchangecontrolprocedureandauthorised.Itshall
includeprovisionforperiodicreviewandrevisionasnecessary.
•Productrelatedrecordsshallberetainedforatleastoneyearafter
theexpirydateofthefinishedproduct.
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8. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
GOOD DOCUMENTATION PRACTICE
GENERAL GUIDELINES
Documentsshall:
–bedesigned,preparedandlaidoutinanorderlyfashion
–bewrittenindetailandinsimplelanguagethatcanbeeasilyunderstoodby
theuser
–haveunambiguouscontents
–havetitle,natureandpurposeshallbeclearlystated
–notbehand-written
–beregularlyreviewedandkeptuptodate
–preventinadvertentuseofsupersededdocuments,whentheyhavebeen
revised
–beapproved,signedanddatedbyanauthorisedperson
–bedistributedwithcare
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9. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
Reproduceddocumentsshall:
–beclear,legibleanddulyauthorised.
–notallowanyerrorduringthereproductionofdocuments
Recordsshall:
–bemadeinclear,legible,andindeliblehandwriting.Sufficientspace
shallbeprovidedforsuchentries.
–besignedanddated,andwhereappropriatethereasonofthe
alterationtoberecordedwhenanyalterationmadetotheentryona
document.Thealterationshallpermitthereadingoftheoriginal
information.
–bemadeorcompletedatthetimeeachactionistakenandinsucha
waythatallsignificantactivitiesconcerningthemanufacturethe
productaretraceable.
–bereadilyavailablethroughouttheperiodofretention.
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GOOD DOCUMENTATION PRACTICE
GENERAL GUIDELINES

10. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
GOOD DOCUMENTATION PRACTICE
GENERAL GUIDELINES
ElectronicData:
Datamayberecordedbyelectronicsystems,photographicorotherreliable
means,butthereshall:
–bedetailedprocedure(e.g.SOP)relatingtothesysteminuse
–becheckedandverifiedforaccuracyoftherecords
–beauthorisedpersonneltoenterormodifydatainthecomputer
–bearecordofchangesanddeletions
–betraceabilitytoallrawdata
–berestrictedbypasswordsorothermeansforaccess
–beindependentlycheckedandverifiedfortheresultofentryofcritical
data
–beprotectionandback-upforallbatchrecords.
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11. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
GOOD DOCUMENTATION PRACTICE
GENERAL GUIDELINES
•Themanufacturershallpracticewhatisdocumentedinthewritten
procedures.
•Undercircumstanceswherethereisachangeinthepractice,the
writtenproceduresshallbepromptlyupdated.
•Ifawrittenprocedurewasrevised,appropriatetrainingshallbe
providedtoensurethatthepersonnelcarryouttheworkin
accordancetotherevisedprocedure.
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12. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
TIERS OF DOCUMENTATION
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Broadly, all documents relating to
quality fall in to the following
categories:
Quality Manual (optional)
Procedures (QSP and SOP)
Work Instructions (can be
merged with Procedures)
Records
Legend:
QSP -Quality Standard Procedure
SOP -Standard Operating Procedure
All levels are integrated to form a comprehensive and cohesive documentation
network via a system of cross referencing
Records
Work Instructions
Procedures
Quality
Manual

13. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
TIERS OF DOCUMENTATION
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QM
QSP #03
QSP #02
STANDARD
PROCEDURE
QSP #01
QUALITY
MANUAL
(optional)
WI #03
WI #02
WORK
INSTRUCTION
WI #01
WP #03
WP #02
WORK
PROTOCOL
WP #01
STD #03
STD #02
STANDARD
TEST /
SPECIFICA-TION
STD #01
CE #03
CE #02
CODE
ETHICS /
WORK
POLICY
CE #01
IL #03
IL #02
IDENTITY
LABELS
IL #01

14. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
QUALITY MANUAL (OPTIONAL)
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The strategic document that outlines the organization’s system of providing
quality assurance to achieve customer satisfaction.
Objectives :
Describe the quality system structure
Declare the quality policy and organization goal
Describe how the organization meets the quality goal
Content of quality manual :
The quality policy declaration
The goal of quality;
The organisational structureincluding
responsibility and authority of each key
personnel
Procedures, instructions and resources for
implementing the quality management.
User :
All personnel in the organization
Another parties, auditors, and customers
RecordsRecords
Work Instructions
Procedures
Quality
Manual

15. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
PROCEDURES
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The tactical document that outlines the activities or operations of the
organisationin implementing the stated quality policies.
Objectives:
Describeindetailhowactivitiesshouldbedone,controlledand
recordedinimplementingthedefinitepolicy
StandardOperatingProceduresexplains:
Whattheprocessisandit’spurpose
Whereactivityisoperating
Whoisresponsibleforeveryactivity
Whenactivityiscompleted,sequentialof
theactivities,frequency,etc.
Howactivitycanbefinishedfollowthework
instructiondesignorotherreference
documents
Referencetotheotherrelevantdocuments
User:
Allpersonnelwhosetupandrunthe
processes
Records
Work Instructions
Procedures
Quality
Manual
Procedures

16. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
SUPPORTING DOCUMENTS OR
WORK INSTRUCTIONS
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The operational document containing instructions specifying how the
activities are performed or products are accepted.
Records
Procedures
Quality
Manual
Objectives :
Itisaninstructiondocument,stepbystepforguideline
toexecutethedailyactivityoroperationforpersonnelin
everyfunction
It is used departmentally, every task or every line.
Contentofworkinstructions:
Detailedexplanationofinstructionstofinish
thejob,detailedhandlingofmethod,
equipmentandmachine
Relatedtothetechnicalmatterswithstressing
foroperation,inspection&testing.
User:
Allpersonnelwhooperatesthecertaintask
Supportingdocuments:
Worksheet,checklist
Visual(illustration,flowchart,layoutplan,
photo)
Work Instructions

17. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
S.O.P. versus W.I.
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Process oriented
Describe step of procedure
Supporting the Quality Manual
Explain general description on
certain process and give
systematic action to ensure
product quality
Procedure guideline which
involve several departments
and/or sections
During implementation need
other supported documents
Guideline at organization level
QUALITY PROCEDURE/SOP
Task oriented
Describe detail instruction
Operation guidance
Dedicated to explain special task,
method, or technique which
should be done to achieve target
quality
Instruction guidance which
dedicated for certain department
or section only
During implementation can stand
alone
Guidance at operational level
WORKING INSTRUCTION
SOP and WI can be merged depending on the documentation system adopted by the company

18. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
RECORDS
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Records, including charts and data pertaining to design, inspection, testing,
survey, audit, review or related results, should be maintained as important
evidence to demonstrate:
Quality System has been effectively
implemented;
that products and services have been
developed and delivered appropriately with the
requirements.
All Records should be :
legible and clear;
Dated;
readily identifiable and retrievable;
carry authorisationstatus;
retained for a designated period;
protected from damage and deterioration while
storage.
All calculations should be duly recorded
Work Instructions
Quality Procedures
Quality
Manual
Records

19. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
FORMAT OF DOCUMENT
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No“bestformat”indocumentationsystem.
Eachdocumentshouldbesuitableforallusers
Ingeneral,allqualitydocumentscanbewritteninthe
followingformat:
narrative
flowchart
combinationnarrativeandflowchart
electronic/computerizedsystem

20. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
DOCUMENT NUMBERING SYSTEM
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Everydocumentshallhaveauniquenumber
•tofacilitatetraceability
•Yetsimpletofacilitatesavingandcontrollingofthe
document

21. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
CONTENT OF DOCUMENT
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Whatshouldbewritteninthedocument:
•Nameofdocument
•Nameofcompany,departmentordivisionofthemaker
•Documentnumber
•Revisionnumber
•Pageandnumberofpagesofdocument
•Dateofapproved
•Effectivedate
•Nameandsignatureofthepersonwhopreparedthedocument
•Namesandsignaturesofthepersonwhoreviewedandperson
approvedthedocument
•Contentofprocedure/instruction

22. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
NARRATIVES DOCUMENT
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•Themostcommonformatbeingused
•Thenarrativedocumentcanbedescribedasthefollowing:
Policyreference
Objective:whyandforwhat
Coveragearea
Documentreference
Responsibleperson
Detailprocedure
Recordifneeded

23. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
FLOWCHART DOCUMENT
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Schematicrepresentationwhichdescribetheflowof
processesincertaintargetactivity
Veryclearandeasytounderstand
Sampleoftheflowchartdocumentcanbewrittenas
besideschema
Forcomplicatedprocess,sometimesflowchartalone
mightnotbeabletocapturedetailedinformation
thereforeitshouldbecombinedwithanarrative

24. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
Incoming Packaging
Material
Quality Control
Sampling / Testing
Incoming Starting
Material
Quality Control
Sampling / Testing
Dispensing
Mixing
In Process Quality
Control
Filling
In Process Quality
Control
Packaging /
Cartoning
Finished Product
Quality Control
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Typical
Production
Flowchart
Rejected
Failed
Passed
Rejected
Failed
Warehouse
Passed
Rejected
Rejected
Passed
Passed
Failed
Failed
Rejected
Failed
Passed

25. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
COMBINED DOCUMENTS
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Sometimes narrative document and flowchart are also
supported by design/lay out
Legend
1= Mixer
2= Intermediate bin with activated discharge
3= Feed metering unit
4= Metal separator
5= UPZ fine impact mill with pin discs
6= UPZ fine impact mill with pin discs
7= Automatic reverse-jet filter
8= Fan
9= Rotary valve
10= End-product bin with activated discharge
11= Bagging unit
12= Control cabinet
A= Feed product
B= Perfume addition
C = End product

26. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
DOCUMENT CONTROL
26
Asmentionedinthepreviousslides,documentsshall:
•Beapproved,signedanddatedbyappropriateauthorised
persons
•Beproperlyauthorizedbeforemakinganychange
•Recordsshallbemadeorcompletedeachtimeactionistaken
insuchawaythatallsignificantactivitiesconcerningthe
manufactureoftheproductaretraceable
•Thereshallalsobeawaytodifferentiatemasterhardcopy
documentfromallduplicatedcopies(e.g.stamp“MASTER
WHENRED”onmastercopyandstamp“CONTROLLEDCOPY”
ondistributedcopies)
•Distributeddocumentsshouldberecorded(e.g.using
distributionlist)

27. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
DOCUMENT CONTROL
27
•Obsoletedocuments:
•Controlcopiesshallberetrievedfromusersbasedon
distributionlistandproperlydestroyedtoprevent
inadvertentuse
•Obsoletemasterdocumentsshallbemarked“obsolete”
andarchived
•Createalist/indexofalldocumentsestablished

28. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
DISTRIBUTION OF DOCUMENTS
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•Onlyup-to-datedocumentsshallbedistributed
•Copyofdocumentsshouldbedistributedtorelevantparties
andavailableatpointofusee.g.ProcessingandPackaging
InstructionsshouldbeavailableinProductionAreas
whereasTestMethodsshallbeavailableinQClabs
•OnlydocumentControllerorQC/QAareauthorisedto
distributethedocumentinaccordancetowrittenprocedure

29. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
REVIEW AND REVISION OF
DOCUMENTS
29
•Documentsshallbereviewedperiodicallytoconfirmthatthey
areuptodate.
•Changestotheprocedures/stepsonthedocumentshallgo
throughtheproperchangecontrolandapprovedbyan
authorisedperson
•Thenewlyreviseddocumentsshallstate:
•Thedateofrevision
•Reasonfortherevision
•Theneweffectivedate

30. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
RECORD KEEPING RULES
“Do Not” Rules
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•DONOTleaveanyblanksinforms(shallindicate“nil”or
“N/A”whenthereisnolegitimateentry)
•DONOTleavemistakesuncorrected(checkyourentries)
•DONOTscribbleoutmistakes(shallnotobscureoriginal
entries)
•DONOTwritecorrectentriesoverincorrectentries(writing
overshallnotobscureoriginalentries)
•DONOTforgettoinitialanddateentry
•DONOTusepencil(allentriesshouldbemadeusing
permanentink)

31. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
LIST OF DOCUMENTS REQUIRED
1.Quality Control Documents
2.Production Documents
3.Standard Operating Procedures (SOPs) and Records
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32. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
QUALITY CONTROL DOCUMENTS
•Must be readily available from Quality Control Dept.:
–Specifications:
•Natural materials
•Starting and packaging materials
•Intermediate and bulk products
•Finished products (FP)
–Sampling Procedures
–Testing Procedures and records (incl. analytical worksheets and/or
laboratory notebooks)
–Analytical reports and/or certificates
–Data from environmental monitoring, if appropriate
–Procedures for and records of calibration of instruments and
maintenance of equipment
•Any QC documentation (e.g. test records, data, reports, etc)
relating to batch record –retained at least one year after
expiry date of Finished products
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33. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
QUALITY CONTROL DOCUMENTS
Specifications:
–Describe the required characteristics or composition of a
product or material or test, while test procedure is required
to evaluate the specific quality attributes
–Provide the specific details defining the quality of:
•Natural materials
•Starting material
•Packaging materials,
•Intermediate and bulk products
•Finished products
–All specifications should be approved by authorised
personnel (QC/QA manager)

34. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
SPECIFICATIONS –NATURAL MATERIALS
Whereappropriatethecontentshallincludefor:
−Scientificnameandifpossiblewithreferencetotheauthors.
−Detailstothesourceofthenaturalmaterial(countryorregionoforigin,
cultivation,timeofharvesting,collectionprocedures,possiblepesticides
used,etc.).
−Wholeplant/animaloronlyapartmaterialisused.
−Whendriedplant/animal,dryingsystemshallbespecified.
−Pictorialdemonstrationmacroscopicaland/ormicroscopicalexamination
−Storageconditionandshelflifewhereapplicable
Annex1–SpecificationforFoeniculivulgare
Assuranceformaterialsfromanimalpartsoriginshouldbefreefrom
undesirabledisease(e.g.TransmissibleSpongiformEncephalopathy).
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35. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
SPECIFICATIONS –NATURAL MATERIALS
Testingproceduresshallbeavailableifthefollowingtests
areconducted(whereappropriate):
–Identificationstests(incl.activeconstituents,knownmarkers)
–Assay(knowntherapeuticactivityormarkerswherepossible)
–Limittestse.g.Ashvalue,presenceofessentialoils,losson
drying
–Testforheavymetalsandlikelycontaminants,foreignmaterials
andadulterants
–Testsforradioactivity,mycotoxin,fungalandmicrobial
contamination
–TestsforresidualsolventsinextractsorFinishedProducts(if
applicable)
–Othertests,asrequired.
Annex2–TextMethodforFoeniculivulgare
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36. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
SPECIFICATIONS –STARTING MATERIALS &
PACKAGING MATERIALS
•AllStartingandPackagingMaterialsspecifications
shouldconsistofthefollowingdata,whereapplicable:
–Descriptionofthematerial
Designatednameofmaterial&internalcodereference
Reference,ifany,topharmacopoeiamonograph
Nameofapprovedsuppliers,andifpossible,originalproducerofthe
products
Specimenofprintedmaterials,includingcolour
Microbiologicalstandards,ifany;
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37. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
SPECIFICATIONS –STARTING MATERIALS &
PACKAGING MATERIALS
Whereappropriatethecontentshallincludefor:
•directionsforsamplingandtestingorreferenceto
procedures;
•qualitativeandquantitativerequirementswith
acceptancelimits;
•storageconditionsandprecautions;and
•themaximumperiodofstoragebeforere-examination
•Assuranceformaterialsfromanimalpartsoriginshouldbe
freefromundesirabledisease(e.g.Transmissible
SpongiformEncephalopathy).
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Annex 3 –Specification for Ascorbic Acid
Annex 4 –Test Method for Ascorbic Acid

38. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
SPECIFICATIONS
–INTERMEDIATE AND BULK PRODUCTS
•Specificationsforintermediateandbulkproducts,
−shallbeavailableifpurchasedortransferred,
−orifdataobtainedfromintermediateproductsare
usedfortheevaluationofthefinishedproduct
−thespecificationsshallbesimilartospecificationsfor
startingmaterialsorforfinishedproducts
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39. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
SPECIFICATIONS –FINISHED PRODUCTS
All specifications of finished products should describe the
following:
•Designated name of product (and internal code reference where
applicable);
•Formula or a reference to;
•Description of dosage form andpackage details;
•Directions for sampling andtesting or reference to procedure
where applicable;
•Qualitative andquantitative requirements with acceptable limits
where applicable;
•Storage condition andany special handling precautions, where
applicable;
•Shelf-life or expiry date.
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40. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
SPECIFICATIONS –FINISHED PRODUCTS
Specifications for finished products(contd.):
−Qualitativeand quantitative requirements, with the
acceptance limits, where applicable:
Physical appearance such as colour, taste, texture,
size, etc;
Uniformity of weight (for tablets and capsules),
disintegration (for tablets, capsules and pills),
hardness and friability (for tablets), and viscosity
(for internal and external liquids);
Heavy metals limits;
Microbial limits;
Other tests, as required, such as preservatives
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41. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
OTHER QUALITY CONTROL DOCUMENTS
ForotherQualityControlDocuments(e.g.Sampling
Procedures,TestingProceduresandrecords,
Analyticalreportsand/orcertificates)pleasereferto
thedetailsChapter7–QualityControl
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42. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
PRODUCTION DOCUMENTS
–Manufacturing Formula and Processing Instructions
–Packaging Instructions
–Batch Processing Records
–Batch Packaging Records
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43. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
PRODUCTION DOCUMENTS
–MANUFACTURING FORMULA
FormallyauthorisedManufacturingFormulaandProcessing
Instructionsshouldbeavailableforeachproductandbatchsizetobe
manufacturedandoftentheyarecombinedinonedocument
Shallinclude:
•Productnamewithreferencecoderelatingtoitsspecification
•Descriptionofproductdosageformandstrength,andbatchsize
•Listofallstartingmaterials
–Amountofeach
–Designatednameandreferencewhichisuniquetothematerial
–Substancethatmaydisappearduringprocessing
•Statementofexpectedfinalyieldwithacceptancelimits.
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44. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
PRODUCTION DOCUMENTS
–PROCESSING INSTRUCTIONS (1)
Shallinclude:
•Statementofprocessinglocationandequipmentused
•Method/SOP(orreferencetomethods)forsettingup
equipmente.gcleaning,assembling,calibrating
•Detailedstepwiseprocessinginstruction(e.g.Checkson
materials,pre-treatments,sequenceforaddingmaterialsetc)
•Instructionsforanyin-processcontrolswithlimits
•Requirementsforbulkstorageofproducts;includecontainer,
labelling,specialstorageconditionsifapplicable
•Anyspecialprecautions.
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45. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
PRODUCTION DOCUMENTS
–PROCESSING INSTRUCTIONS (2)
•Shalldescribethedifferentoperationscarriedoutuponcrude
materialsuchas:
–Sorting
–Cleaning
–Drying
–Crushing,and
–Sifting
•Shallincludedryingtime,temperatures,andmethodsusedto
controlfragmentorparticlesize
•Shallalsodescribesievingprocess/othermethodsof
removingforeignmaterials.
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46. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
PRODUCTION DOCUMENTS
–PROCESSING INSTRUCTIONS (3)
•In particular, written instructions and records, shall be
available to ensure that each container of the product is
carefully examined to detect any adulteration/substitution or
presence of foreign matter, such as:
–metal, glass pieces, animal parts or excrement, stones, sand or rot
and signs of decay.
•For product preparation, instructions shall include:
–details of base or solvent
–time and temperatures of extraction,
–details of any concentration stages and
–methods used.
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47. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
PACKAGING INSTRUCTIONS
•Formally authorisedPackaging Instructions should be
available for each product pack size and type.
•Shall include:
–Product name
–Description of product dosage form, strength (if applicable)
–Pack size (expressed in terms of number, weight or volume of
product in final container)
–Complete list of all packaging materials required for standard
batch size including quantities, sizes and types with the code or
reference number relating o the specifications of each
packaging material
–An example/ copy of relevant printed packaging materials and
specimens indicating where to apply batch number references,
and shelf life of the product
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48. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
PACKAGING INSTRUCTIONS
•Special precautions to be observed
•Description of packaging operation
•Details of in-process controls with instructions for
sampling and acceptance limits
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49. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
BATCH PROCESSING RECORDS
•BatchProcessingRecordisthatpartofBatchManufacturing
Record
•Shouldbekeptforeachbatchprocessed
•Shouldbebasedontherelevantpartsofthecurrently
approvedManufacturingFormulaandProcessingInstructions.
•Methodofpreparationofsuchrecordsshallbedesignedto
avoidtranscriptionerrors.
•Recordshouldcarrythebatchnumberoftheproductbeing
manufactured.
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50. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
BATCH PROCESSING RECORDS
Before any processing begins line clearance should be
done and documented:
–Recorded verification that equipment and work station
clear of previous products, documents or materials not
required for planned process
–Equipment clean and suitable for use
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51. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
BATCH PROCESSING RECORDS
During processing, the following should be recorded at time
action is taken, and after completion, and the record shall be
dated and signed by person responsible for processing
operations:
–Product name
–Dates and times of
Initiation
significant intermediate stages and
Completion of production
–Name of person responsible for each stage of production
–Date and signature of operator of different significant steps of
production and where appropriate, of the person who checked
each of these operations (e.g. weighing, adding active material)
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52. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
BATCH PROCESSING RECORDS
•Batchnumberand/oranalyticalcontrolnumberinclude
quantitiesofeachstartingmaterialactuallyweighed
•Anyrelevantprocessingoperationoreventandmajor
equipmentused
•Arecordofin-processcontrols,dateandsignatureofperson
carryingthemoutandresultsobtained
•Productyieldobtainedatdifferentandpertinentstagesof
manufacture
•Notesonspecialproblemsincludingdetails,withsigned
authorisationforanydeviationfromthemanufacturing
formulaandprocessinginstructions
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53. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
BATCH PACKAGING RECORDS
•IspartofManufacturingRecordandshouldbekeptforeach
batchorpartofbatchprocessed.
•ShallbebasedonrelevantpartsofPackagingInstructions
•Methodofpreparationofsuchrecordsshouldbedesignedto
avoidtranscriptionerrors
•RecordshallcarryBatchNumber(BN)andquantityofbulk
producttobepacked,aswellasBNandplannedquantityof
FinishedProducts(FP)thatwillbeobtained
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54. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
BATCH PACKAGING RECORDS
Before any packaging operation begins:
–Recorded checks that equipment and work station clear of
previous products, documents or materials not required
for planned packaging operations
–Equipment clean and suitable for use
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55. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
BATCH PACKAGING RECORDS
Informationshouldbeenteredattimeeachactionistaken,and
aftercompletion,andtherecordshallbedatedandsignedby
person(s)responsibleforpackagingoperations:
i.Productname
ii.Datesandtimesofpackagingoperation
Whenthereisriskofcontamination,packaging
activityshouldbedonewithinthedayitself
iii.Nameofresponsiblepersonscarryingoutpackaging
operation
iv.Dateandsignatureofoperatorsofdifferent
significantsteps
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56. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
BATCH PACKAGING RECORDS
v.RecordsofverificationforidentityandconformitywithPackaging
Instructionsincludingtheresultsofin-processcontrols
vi.Detailsofpackagingoperationscarriedout,includingreferencesto
equipmentandthepackaginglinesused
vii.Samplesofprintedpackagingmaterialsused,whichincludethe
batch/lotnumber,expirydateandanyadditionaloverprinting
viii.Notesonanyspecialproblemsorunusualevents
ix.Quantitiesandreferenceno.oridentificationofallprinted
packagingmaterialsandbulkproductissued,used,destroyedor
returnedtostockandquantitiesofobtainedproduct–for
adequatereconciliation
Annex 5-Sample Batch Manufacturing Record
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57. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
STANDARD OPERATING PROCEDURES (SOPS)
& RECORDS
•Written procedures and records must be available for
receipt of each delivery of each starting materials and
packaging material.
•Records of receipt should include the following:
–Name of material on delivery note and containers
–In-house name and/or code of material
–Date of receipt, date and signature of receiving staff
–Name of supplier and manufacturer
–Manufacturer’s batch/reference no.
–Total quantity and no. of containers obtained
–Batch Number assigned after receipt
–Any relevant comment (e.gState of containers)
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58. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
STANDARD OPERATING PROCEDURES (SOPS)
& RECORDS
•SOPsshouldbeavailableforthefollowing:
–Internallabelling,quarantineandstorageofstarting
materials,packagingmaterialsandothermaterialsas
appropriate
–Operationofeachequipmentandplacedinclose
proximitytoinstrumentorequipment
–Sampling(whichspecifypersonauthorisedtotake
samples,samplingtools,andsamplinginstructions)
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59. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
STANDARD OPERATING PROCEDURES (SOPS)
& RECORDS
Describedetailsofbatch/lotnumberingsystem
•Objective–ensuringeachbatchofintermediate,bulk,orFinish
ProductsisidentifiedwithaspecificBatchNumber
•BatchnumberingproceduresshallassurethatsameBatchNumber
willnotberepeatedlyused;thisappliesalsotoreprocessing.
•BatchNumberallocationshouldbeimmediatelyrecordede.g.in
logbook.
•Recordshouldincludedateofallocation,productidentityandsizeof
batch.
•SOPforbatchnumberingthatareappliedtoprocessingstageandto
respectivepackagingstageshouldberelatedtoeachother.
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60. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
STANDARD OPERATING PROCEDURES (SOPS)
& RECORDS
•Quarantine,releaseandrejectionofmaterialsandproducts,
inparticularreleaseforsaleofFinishProductsbyauthorised
person.
•Recordsshallbemaintainedofdistributionofeachbatchof
productinordertofacilitaterecallofbatchifnecessary.
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61. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
STANDARD OPERATING PROCEDURES (SOPS)
& RECORDS
•SOPsandassociatedrecordsshouldbeavailablefor
thefollowing:
–equipmentassembly;
–operationofanalyticalapparatusandcalibration;
–maintenance,cleaning,andsanitisationofequipmentand
premises;
–personnelmattersincludingqualification,GMPtraining,
clothing,andhygiene;
–environmentalmonitoring;
–pestcontrol;
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62. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
STANDARD OPERATING PROCEDURES (SOPS)
& RECORDS
SOPsandassociatedrecordsshouldbeavailableforthe
following:
–adverseproductreactions,complaintsandproductrecalls
–returnsand recoveredproducts,rejected
products/materials;
–disposalanddestructionoftherejectedproducts/materials;
–self-inspection/qualityaudit
–changecontrol,handlingdeviation,CorrectiveAction
PreventiveAction(CAPA)
–productqualityreview
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63. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
STANDARD OPERATING PROCEDURES (SOPS)
& RECORDS
•Logbooks
–Shouldbekeptformajororcriticalequipment
–Shallrecordtheusage(nameofproductsandbatchnumber)andas
appropriate,anycalibrations,maintenance,cleaning,orrepair
operations,includingdatesandtheidentityofthepeoplewhocarried
outtheoperations
–Shouldberecordedinchronologicalorder(foruseofequipmentand
areaswhereproductbeenprocessed).
•Severalofthementionedprocedures,specificationsand/orrecords
maybecombinedtogetherinonespecificdocument,e.g.:
a)BatchProcessingInstructionandBatchPackagingInstruction;and
b)ProcessingRecordsandBatchPackagingRecordscanbemergedinto
asingledocument.
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64. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
REFERENCES
1.ASEANGuidelinesonGoodManufacturingPracticefor
TraditionalMedicines.
2.ASEANGuidelinesonGoodManufacturingPracticefor
HealthSupplements.
3.ASEANTrainingModuleonGuidelineforCosmetic
GMP(2003)–ChapteronDocumentation(2005).
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65. ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements -2015
Chapter 5 -Documentation
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