PDATR60工艺验证：生命周期方法.pdfVIP

PDATR60工艺验证：生命周期方法

1.0INTRODUCTION(1)

1.1PurposeandScope(1)

1.2Background(1)

2.0GLOSSARYOFTERMS(6)

2.1Acronyms(9)

3.0BUILDINGANDCAPTURINGPROCESS

KNOWLEDGE(STAGE1—PROCESSDESIGN)10

3.1DeliverablesfromStage1

ProcessValidation(12)

3.2QualityTargetProductProfile(QTPP)(12)

3.3CriticalQualityAttributes(13)

3.4DefinetheManufacturingProcess(14)

3.5AnalyticalMethods(20)

3.6RiskAssessmentandParameterCriticality

Designation(20)

3.7ProcessCharacterization(23)

3.8ProductCharacterizationTestingPlan(23)

3.9ControlStrategy(24)

3.10ClinicalManufacturingExperience–Batch

RecordsandProductionData(25)

3.11ProcessDesignReport(26)

3.12ProcessValidationMasterPlan(26)

3.13Stage1ManufacturingandTechnology

Considerations(26)

4.0PROCESSQUALIFICATION(STAGE2)(28)

4.1StrategiesforSystemDesignand

Qualification(28)

4.1.1EngineeringandDesign(29)

4.1.1.1RiskAssessment(29)

4.1.2Installation(29)

4.1.3QualificationPlan(29)

4.1.3.1TestFunctionsand

AcceptanceCriteria(30)

4.1.4MaintainingSystemsina

StateofControl(30)

4.2ProcessPerformanceQualification(31)

4.2.1PPQReadiness(31)

4.3DesignStrategyforProcessPerformance

Qualification(PPQ)(33)

4.3.1UseofPriorKnowledgeandStage1

DatatoSupportPPQ(33)

4.3.2PPQStudyDesign(34)

4.3.2.1NumberofBatches(35)

4.3.2.2PPQatNormalOperatingConditions.35

4.3.2.3PPQUsingIndividualUnitOperation

Studies(36)

4.3.2.4PPQUsingBracketing,Matrix,

andFamilyApproaches(36)

4.3.2.5BracketingApproach(36)

4.3.2.6MatrixApproach(36)

4.3.2.7Family(Grouping)Approach(37)

4.3.2.8ProcessAnalyticalTechnology(38)

4.3.2.9SamplingStrategy(39)

4.3.2.10SettingPPQAcceptanceCriteria(39)

4.4PPQProtocol(40)

4.5PPQReport(42)

4.6TransitiontoContinuedProcessVerification43

5.0CONTINUEDPROCESSVERIFICATION

(STAGE3)(44)

5.