1. Module 4Slide 1 of 23 WHO - EDM Validation Basic Principles of GMP

2. Module 4Slide 2 of 23 WHO - EDM Validation Objectives l To review the definition and types of validation l To understand the requirements for documentation and key stages in the process of validation l To consider models for process validation

3. Module 4Slide 3 of 23 WHO - EDM Validation Definition l Validation is the documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected result

4. Module 4Slide 4 of 23 WHO - EDM Validation Essential Part of GMP l Predetermined protocols l Written reports l Processes and procedures l Periodic revalidation l Specific attention: ä processing ä testing ä cleaning

5. Module 4Slide 5 of 23 WHO - EDM Annex 6 Validation WHO References l Good manufacturing practices: guidelines on the validation of manufacturing processes l Validation of analytical procedures used in the examination of pharmaceutical materials

6. Module 4Slide 6 of 23 WHO - EDM Validation Types of Process Validation l Experimental approach ä Prospective validation ä Concurrent validation l Analysis of historical data ä Retrospective validation l Revalidation ä Periodic revalidation ä Revalidation after change

7. Module 4Slide 7 of 23 WHO - EDM Validation Stages of Validation l Design qualification (DQ) l Installation qualification (IQ) l Operational qualification (OQ) l Performance qualification (PQ)

8. Module 4Slide 8 of 23 WHO - EDM Validation Priorities for Process Validation Type of processRequirement l NewEvery new process before approval for routine l Existing: ä Sterile productsAll processes affecting the sterility, and manufacturing environment including sterilization stage ä Non-sterileLow dose tablets and capsules: mixing and granulation; content uniformity (and other parameters) Other tablets and capsules: uniformity of mass (and other parameters)

9. Module 4Slide 9 of 23 WHO - EDM Validation Types of Documentation l Validation Master Plan (VMP) l Validation protocols (VP) l Validation reports(VR) l Standard Operating Procedures (SOPs)

10. Module 4Slide 10 of 23 WHO - EDM Validation l The Validation Master Plan could consist of: ä Approval page and table of contents ä Introduction and objectives ä Facility and process description ä Personnel, planning and scheduling ä Responsibilities of committee members ä Process control aspects ä Equipment, apparatus, processes and systems to be validated ä Acceptance criteria ä Documentation e.g.validation protocols and reports ä SOPs ä Training requirements

11. Module 4Slide 11 of 23 WHO - EDM Validation l Protocol ä Objectives of the validation and qualification study ä Site of the study ä Responsible personnel ä Description of the equipment ä SOPs ä Standards ä Criteria for the relevant products and processes

12. Module 4Slide 12 of 23 WHO - EDM Validation l Report ä Title ä Objective of the study ä Refer to the protocol ä Details of material ä Equipment ä Programmes and cycles use ä Details of procedure and test methods