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1、2011PDASoutheastChapterSpringConference(April26,2011)ThePast–ABriefHistory•ReleasetestingProcessValidation•GoodManufacturingPractices(1978)•Processdefinestheproduct•1987PVGuidelinesPast,Present,andOpportunities...•QRM–QualityRiskManagement•Q8,Q9,Q10,PAT,Li
2、fecycle,QbD...MarkWitcher,Ph.D.witchermf@aol.com•2009DraftPVGuidelines–“Basedonexperience...”PDA4-26-111PDA4-26-112Present-RecentGuidelineandPolicy2011PVGuidelines•“ProcessValidation:GeneralPrinciplesand•EstablishesPVParadigmPractices”(January,2011)–Stage#
3、1:Design–Stage#2:Qualification•MAPP5016.1CDER–Policy&Procedures–Stage#3:Verification“ApplyingICHQ8(R2),Q9,Q10PrinciplestoCMC–ReferencesASTMdocumentsReview”(2/8/11)•ASTME2500–“GoodEngineeringPractices”–ASTM–E2500-07:“StandardGuideforSpecification,Design,and
4、VerificationofPharmaceuticalandBiopharmaceuticalManufacturingSystemsandEquipment”PDA4-26-113PDA4-26-114MarkF.Witcher,Ph.D.(witchermf@aol.com)1of712011PDASoutheastChapterSpringConference(April26,2011)FDAPolicy&Procedures–MAPP5016.1Present–QualitybyDesign(Qb
5、D)•ApplicationofQ8,Q9,&Q10toCMCreview•FDAdefinition:“Asystematicapproachto–QualitybyDesign(QbD)encouraged...developmentthatbeginswithpredefinedobjectivesandemphasizesproductandprocessunderstanding–“Application”=expectation=enforcement?andprocesscontrolbase
6、donsoundscienceand•Reasonableextensionsqualityriskmanagement.”-ICHQ8–2011PVGuidelines–CMCsection=>widerapplication?•Industry–feelgooddefinitions•Oldterm,newapplication...–Software...•OpportunityforaworkingdefinitionofQbDPDA4-26-115PDA4-26-116Present–Proces
7、sDevelopmentPresent–QualityRiskManagement•ICHQ8(R2)–PharmaceuticalDevelopment•ICHQ9–QualityRiskManagement(QRM)–Lifecycle–Patientrisk–awareness!–QualitybyDesign(QbD)–Ubiquitousapplication–DesignSpace•Compliancevs.performance–Goodscience&engineering–Complian
8、ce-poorsurrogateend-point–Continuousimprovement–Eyeofthebeholder•Opportunity–evolveconceptsPDA4-26-117PDA4-26-118MarkF.Witcher,Ph.D.(witchermf@aol.com)2of722011PDASoutheastChapterSpringConference(April26,2011
