as of 2019 - 08 - 15
7 Process Validation
7.A Official requirements and agency expectations
Summary
7.A.1 Principles of process validation
7.A.1.1 The purpose of process validation
7.A.1.2 Process validation during the product life cycle
7.A.1.3 Data quality
7.A.1.4 Personnel qualification
7.A.1.5 Acceptance criteria
7.A.1.6 Validation strategy
7.A.1.7 Documentation and dealing with changes
7.A.1.8 Responsibilities
7.A.2 Regulatory basis of the process validation
7.A.2.1 European regulations
7.A.2.2 German regulations
7.A.2.3 PIC/S requirements
7.A.2.4 USA: FDA requirements
7.A.2.5 Canada: Health Canada requirements
7.A.2.6 Australia: requirements of the Therapeutic Goods Administration (TGA)
7.A.2.7 Requirements of the WHO
7.A.2.8 Other guidelines and standards
7.A.3 Conditions and requirements for the implementation of process validation
7.A.3.1 Human resource management
7.A.3.2 Information and documentation management
7.A.3.3 Resource management
7.A.3.4 Risk management
7.A.3.5 Change and deviation management
7.A.4 Validation during the product life cycle
7.A.4.1 Development and optimisation phase
7.A.4.2 Validation phase
7.A.4.3 Ongoing process verification/revalidation
7.A.5 Validation during the authorisation procedure
7.A.6 Documentation of process validation
7.A.6.1 Validation master plan
7.A.6.2 Validation protocol and report
7.A.6.3 Archiving
7.B Validation – a key element in a QM system
Summary
7.B.1 The significance of validation and the differences between validation and qualification
7.B.1.1 Object and purpose of validation
7.B.1.2 Significance of validation as a QM tool
7.B.1.3 Definition of the terms validation, qualification and verification
7.B.2 The changing concept of validation
7.B.2.1 GMP trends that have significantly changed validation
7.B.2.2 Areas of application of validation and the underlying regulatory documents
7.B.2.3 Common errors and mistakes in a validation environment
7.B.3 Process validation during the product life cycle
7.B.3.1 Validation steps during the product life cycle
7.B.3.2 Continuous process verification
7.B.3.3 Hybrid approach
7.B.4 Process validation and the FDA
7.B.4.1 Terminological differences
7.B.4.2 Objectives and essential points of the three validation stages
7.B.4.3 Special features and focal points of the FDA guidance
7.C Organisation, planning and implementation
Summary
7.C.1 Tasks and responsibilities
7.C.1.1 Validation coordinator
7.C.1.2 Outsourcing validation tasks to third parties
7.C.1.3 Validation team
7.C.2 Validation strategies
7.C.2.1 Continuous process verification (CPV)
7.C.2.2 Traditional process validation
7.C.2.3 Concurrent validation
7.C.3 Scheduled time of validation
7.C.3.1 Traditional validation
7.C.3.2 Continuous process verification (CPV)
7.C.4 Planning and implementation of a traditional validation
7.C.4.1 Requirements for the implementation
7.C.4.2 Scope of the process validation
7.C.4.3 When should risk analyses be carried out?
7.C.5 Ongoing process verification and revalidation
7.C.5.1 Ongoing process verification
7.C.5.2 Periodic revalidation
7.C.5.3 Event-driven revalidation
7.C.6 Continuous process verification (CPV)
7.D Validation documentation
Summary
7.D.1 Structure and archiving
7.D.1.1 Structure of validation documentation
7.D.1.2 Chronology of document creation
7.D.1.3 Archiving validation documents
7.D.2 Validation master plan (VMP)
7.D.2.1 Validation matrix
7.D.2.2 Product groups, bracketing and matrixing
7.D.3 Validation protocol
7.D.3.1 Specification of validation batches
7.D.3.2 Detailed process flow with in-process controls
7.D.3.3 Product specifications and quality attributes
7.D.3.4 Quality of the starting materials used
7.D.3.5 Systems and measuring devices used
7.D.3.6 Risk analysis
7.D.3.7 Critical process steps and critical process parameters (CPPs)
7.D.3.8 Test plans
7.D.3.9 Acceptance criteria
7.D.3.10 Sampling plan
7.D.3.11 Test evaluation methods
7.D.3.12 System qualification and method validation
7.D.3.13 Changes to the validation protocol
7.D.3.14 Participating experts and the time schedule
7.D.3.15 Reference documents
7.D.3.16 Authorisation of the validation protocol
7.D.4 Validation report
7.D.4.1 Manufacturing records
7.D.4.2 Results of all controls and tests
7.D.4.3 Raw data from analytical tests
7.D.4.4 Traceability matrix
7.D.4.5 Deviations from the validation protocol
7.D.4.6 Assessment of the results
7.D.4.7 Determination of follow-up measures
7.D.4.8 Authorisation of the validation report
7.E References
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