PDA TR 60 工艺验证：生命周期方法（2013）【中英对照】

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1、PDATR60工艺验证：生命周期方法（中英对照）TableofContents1.0INTRODUCTION..................................................14.3.2.4PPQUsingBracketing,Matrix,andFamilyApproaches....................361.1PurposeandScope........................................14.3.2.5BracketingApproach...........

2、..............361.2Background...................................................14.3.2.6MatrixApproach..............................362.0GLOSSARYOFTERMS........................................64.3.2.7Family(Grouping)Approach..............374.3.2.8ProcessAnalyticalTechnology

3、.........382.1Acronyms......................................................94.3.2.9SamplingStrategy.............................394.3.2.10SettingPPQAcceptanceCriteria....393.0BUILDINGANDCAPTURINGPROCESS4.4PPQProtocol...............................................40KNOWLEDG

4、E(STAGE1—PROCESSDESIGN)104.5PPQReport..................................................423.1DeliverablesfromStage14.6TransitiontoContinuedProcessVerification43ProcessValidation.......................................123.2QualityTargetProductProfile(QTPP)...........125.0CONTI

5、NUEDPROCESSVERIFICATION3.3CriticalQualityAttributes.............................13(STAGE3)..........................................................443.4DefinetheManufacturingProcess..............145.1EstablishingaMonitoringProgram..............443.5AnalyticalMethods.......

6、...............................205.1.1PurposeandStrategy.............................443.6RiskAssessmentandParameterCriticalityDesignation..................................................205.1.2DocumentingtheCPVProgram..............443.7ProcessCharacterization.............

7、................235.1.3LegacyProductsandContinuedProcess3.8ProductCharacterizationTestingPlan..........23Verification..............................................463.9ControlStrategy...........................................245.1.4DemonstratingContinuedProcessVerification

8、..............................................473.10ClinicalManufacturingExperienc