Annex 15 to the EU Guide to

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1、EUROPEANCOMMISSIONENTERPRISEDIRECTORATE-GENERALSinglemarket,regulatoryenvironment,industriesunderverticallegislationPharmaceuticalsandcosmeticsBrussels,July2001WorkingPartyonControlofMedicinesandInspectionsFinalVersionofAnnex15totheEUGuidetoGoodManufacturingPracticeTitle:Qu

2、alificationandvalidation.FirstdiscussionindraftinggroupDiscussionattheworkingPartyonControlofMedicinesand16September1999InspectionforreleaseforconsultationPharmaceuticalCommittee28September1999Releasedforconsultation30October1999Deadlineforcomments28February2000Finalapprova

3、lbyInspector’sworkingpartyDecember2000PharmaceuticalCommittee(forinformation)April2001DateforcomingintooperationSeptember2001NotethatthisdocumentisbasedinthePICS/Srecommendations2TableofContentsPage1.QualificationandValidation32.PlanningforValidation43.Documentation44.Quali

4、fication55.ProcesssValidation.66.CleaningValidation77.ChangeControl88.Revalidation99.Glossary103QUALIFICATIONANDVALIDATIONPrinciple1.ThisAnnexdescribestheprinciplesofqualificationandvalidationwhichareapplicabletothemanufactureofmedicinalproducts.ItisarequirementofGMPthatman

5、ufacturersidentifywhatvalidationworkisneededtoprovecontrolofthecriticalaspectsoftheirparticularoperations.Significantchangestothefacilities,theequipmentandtheprocesses,whichmayaffectthequalityoftheproduct,shouldbevalidated.Ariskassessmentapproachshouldbeusedtodeterminethesc

6、opeandextentofvalidation.4PLANNINGFORVALIDATION2.Allvalidationactivitiesshouldbeplanned.Thekeyelementsofavalidationprogrammeshouldbeclearlydefinedanddocumentedinavalidationmasterplan(VMP)orequivalentdocuments.3.TheVMPshouldbeasummarydocumentwhichisbrief,conciseandclear.4.Th

7、eVMPshouldcontaindataonatleastthefollowing:(a)validationpolicy;(b)organisationalstructureofvalidationactivities;(c)summaryoffacilities,systems,equipmentandprocessestobevalidated;(d)documentationformat:theformattobeusedforprotocolsandreports;(e)planningandscheduling;(f)chang

8、econtrol;(g)referencetoexistingdocuments.5.Incaseoflargeprojects,itmaybenecessaryt