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1、2003.11.15JPMA GMP Workshop From to Quality System based on Risk Management and Science From to Quality System based on Risk Management and Science Otsuka Pharmaceutical Co., Ltd. Second Tokushima Factory Tetsu Yamada（JPMA） 2003.11.15JPMA GMP Workshop Emerging ApproachEmerging ApproachEmerging Appro
2、achEmerging ApproachEmerging ApproachEmerging ApproachEmerging ApproachEmerging Approach Guideline Guideline Guideline Guideline ICH Q1AICH Q1AICH Q1AICH Q1ASept. 1994Sept. 1994Sept. 1994Sept. 1994 GuidanceGuidanceGuidanceGuidanceSUPACSUPACSUPACSUPAC- - - -IRIRIRIRNov. 1995Nov. 1995Nov. 1995Nov. 199
3、5 GuidanceGuidanceGuidanceGuidanceChanges to an Approved NDA orChanges to an Approved NDA orChanges to an Approved NDA orChanges to an Approved NDA or ANDAANDAANDAANDANov. 1999Nov. 1999Nov. 1999Nov. 1999 GuidelineGuidelineGuidelineGuidelineICH Q6AICH Q6AICH Q6AICH Q6AMay. 2001May. 2001May. 2001May.
4、2001 GuidelineGuidelineGuidelineGuidelineICH Q7AICH Q7AICH Q7AICH Q7ANov. 2001Nov. 2001Nov. 2001Nov. 2001 CPGMCPGMCPGMCPGMSystem Audit System Audit System Audit System Audit Feb. 2002Feb. 2002Feb. 2002Feb. 2002 InitiativeInitiativeInitiativeInitiativeRisk Based ApproachRisk Based ApproachRisk Based
5、ApproachRisk Based ApproachAug. 2002Aug. 2002Aug. 2002Aug. 2002 GuidanceGuidanceGuidanceGuidancePAT (Draft)PAT (Draft)PAT (Draft)PAT (Draft)Sept. 2003Sept. 2003Sept. 2003Sept. 2003 2003.11.15JPMA GMP Workshop MessagesMessages ICH Q1AICH Q1AICH Q1AICH Q1APilot Scale Definition,Stability Requirements
6、SUPACSUPACSUPACSUPAC- - - -IRIRIRIRPost Approval Changes based on Risksbased on Risksbased on Risksbased on Risks Changes to an Approved NDA or ANDAChanges to an Approved NDA or ANDAChanges to an Approved NDA or ANDAChanges to an Approved NDA or ANDA Re-classification of Post Approval Changes based
7、on Risksbased on Risksbased on Risksbased on Risks ICH Q6AICH Q6AICH Q6AICH Q6AParametric Release,Parametric Release,Parametric Release,Parametric Release, Skip TestingSkip TestingSkip TestingSkip Testing ICH Q7AICH Q7AICH Q7AICH Q7AManagement Responsibility, Quality Management Responsibility, Quali
8、ty Management Responsibility, Quality Management Responsibility, Quality Management(Quality review/Management(Quality review/Management(Quality review/Management(Quality review/Change ControlChange ControlChange ControlChange Control) ) ) ) System AuditSystem AuditSystem AuditSystem AuditEfficient I
9、nspection based on Risksbased on Risksbased on Risksbased on Risks Risk BasedRisk BasedRisk BasedRisk Based ApproachApproachApproachApproachScientific approachScientific approachScientific approachScientific approach based on Risksbased on Risksbased on Risksbased on Risks PAT (Draft)PAT (Draft)PAT
10、(Draft)PAT (Draft)Continuous Quality Management through Quality Management through Quality Management through Quality Management through Scientific approachScientific approachScientific approachScientific approach 2003.11.15JPMA GMP Workshop Process followedProcess followed Pilot ScaleParemetricMana
11、gementManagementManagementManagement Release ResponsibilityRelease ResponsibilityRelease ResponsibilityRelease Responsibility StabilityStabilityStabilityStabilityQuality ReviewQuality ReviewQuality ReviewQuality Review Req.Req.Req.Req.Skip TestSkip TestSkip TestSkip Test Change ContChange ContChange
12、 ContChange Cont GMP SUPACSUPACSUPACSUPACSystemSystemSystemSystem PAC toPAC toPAC toPAC toAuditAuditAuditAuditPATPATPATPAT NDA/ANDANDA/ANDANDA/ANDANDA/ANDAGuidance Risk Based Approach ? ? ? ? 2003.11.15JPMA GMP Workshop Direction to be orientedDirection to be oriented Scientific Quality System (Low
13、risk) based on Risk Management and Science Empirical Non-ContinuousContinuous （Low risk） 2003.11.15JPMA GMP Workshop Results of JPMA Questionnaires (16 Responses） Results of JPMA Questionnaires (16 Responses） Q1. Q1. Q1. Q1. Different GMP Expectations Different GMP Expectations Different GMP Expecta
14、tions Different GMP Expectations costly, inefficient and/or additional workcostly, inefficient and/or additional workcostly, inefficient and/or additional workcostly, inefficient and/or additional work . .Manufacture of Sterile Preparations Manufacture of Sterile Preparations Manufacture of Sterile
15、Preparations Manufacture of Sterile Preparations Environmental Standards : Environmental Standards : Environmental Standards : Environmental Standards : E E E Environment standard of nvironment standard of nvironment standard of nvironment standard of aseptic room and airborne microbes. Requirement
16、of aseptic room and airborne microbes. Requirement of aseptic room and airborne microbes. Requirement of aseptic room and airborne microbes. Requirement of additional preadditional preadditional preadditional pre- - - -filter in case of filter upstream is 10cfu filter in case of filter upstream is 10cfu filter in case of filter upstr
