Introduction_to_the_New_Risk_Based_Approach_to_Verification_Validation

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1、IntroductiontotheNewRiskBasedApproachtoVerification/ValidationISPE-CCPIEChinaConference2008Beijing11-12Nov2008StevenWisniewski,SeniorAssociateIPS,ChairmanISPEC&QCoPQuestionWhychangeourworkcultures,®ulatoryframeworktomovefromthetraditionalqualification

2、approachtoavalueaddedmodel?ASTMStandardE2500“ASTMStandardforSpecification,Design&VerificationofPharmaceutical&BiopharmaceuticalManufacturingSystems&Equipment”ThenewASTMstandardprovidesascienceand“riskbased”approachtoassurethatGMPequipment&systemsare;•fit

3、foruse,•performsatisfactorily•maybeusedinthemanufacturing,processing,packaging,andholdingofadrugRegulatoryBasis-ICHIn2005theICHQ9,QualityRiskManagement,waspublishedThisoutlinedhowaneffectivequalityriskmanagement(QRM)approachcan;•furtherensurethehighquali

4、tyofthedrug(medicinal)producttothepatientbyprovidingaproactivemeanstoidentifyandcontrolpotentialriskstothepatientduringmanufacturing.•improvethedecisionmakingifaqualityproblemarises•facilitatebetterandmoreinformeddecisions•provideregulatorswithgreaterass

5、uranceofacompany’sabilitytodealwithpotentialrisks•beneficiallyaffecttheextentandlevelofdirectregulatoryoversightRegulatoryBasis-FDAIntheFinalReportPharmaceuticalCGMPsForThe21stCentury-ARisk-BasedApproachFDAdescribedhowtheirobjectivesincludedthefollowing:

6、•Encouragetheadoptionofconceptsofriskmanagementqualitysystemsapproachesbythepharmaceuticalindustry•Encourageindustrytousegoodscienceandnewtechnologicaladvancesforallaspectsofpharmaceuticalproductionandqualityassurance•Encourageinnovationleadingtoimproved

7、benefittothepatient•FocusbothindustryandAgencyattentiononcriticalareasRegulatoryBasis-EU•In2001,theEMEAissuedthefinalversionofAnnex15toVolume4oftheEUGuideonGoodManufacturingPracticeonQualificationandValidation:“ThisAnnexdescribestheprinciplesofqualificat

8、ionandvalidationwhichareapplicabletothemanufactureofmedicinalproducts.ItisarequirementofGMPthatmanufacturersidentifywhatvalidationworkisneededtoprovecontrolofthecriticalaspectsoftheirparticularoperations.Significantchanges