Module 1,, Part 5: Review and summary Slide 1 of 13 © WHO – EDM Validation Part 5: Review and summary Supplementary Training Modules on Good Manufacturing Practice

Module 1,, Part 5: Review and summary Slide 2 of 13 © WHO – EDM Objectives To review: l WHO validation definition l Philosophy of validation l Personnel requirements l Protocol requirements l DQ IQ OQ and PQ summary l Checklist for validation Validation

Module 1,, Part 5: Review and summary Slide 3 of 13 © WHO – EDM WHO validation definition l The documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results. Validation

Module 1,, Part 5: Review and summary Slide 4 of 13 © WHO – EDM The VMP l The VMP provides a summary of the company ’ s philosophy, policy, intentions and approach to validation. Validation

Module 1,, Part 5: Review and summary Slide 5 of 13 © WHO – EDM The WHO GMP Guidelines state: Validation studies are an essential part of good manufacturing practice and should be conducted in accordance with predefined protocols. l written report and conclusion l process and procedures ä processing ä testing ä cleaning procedures Validation

Module 1,, Part 5: Review and summary Slide 6 of 13 © WHO – EDM Personnel - Validation team members l Quality Assurance l Engineering l Manufacturing l Other disciplines may be involved depending on the product and process: ä laboratory, technical services ä research and development, regulatory affairs ä clinical ä chemical engineering ä purchasing/planning Validation

Module 1,, Part 5: Review and summary Slide 7 of 13 © WHO – EDM Validation Protocol development (1) l Identification of process l Objective and measurable criteria l Length and duration of the validation l Shifts, equipment l Identification and quality of utilities l Identification of operators and operator training and qualification

Module 1,, Part 5: Review and summary Slide 8 of 13 © WHO – EDM Validation Protocol development (2) l Complete description of the process l Relevant specifications and tests l Samples and sampling methods l Special controls or conditions l Process parameters to be monitored l Methods for controlling and monitoring

Module 1,, Part 5: Review and summary Slide 9 of 13 © WHO – EDM Validation Protocol development (3) l Objective and subjective criteria used to evaluate the product l Definition of non-conformance l Statistical methods l Maintenance and repairs l Criteria for revalidation l Criteria for change control

Module 1,, Part 5: Review and summary Slide 10 of 13 © WHO – EDM Validation

Module 1,, Part 5: Review and summary Slide 11 of 13 © WHO – EDM GMP Inspector’s check list for validation (1) Check that the manufacturer has: l A VMP and multi-functional team for validation l Planned approach, defined requirements l Identified and described processes l Analyse the amount of validation work to perform Validation

Module 1,, Part 5: Review and summary Slide 12 of 13 © WHO – EDM GMP Inspector’s check list for validation (2) Check that the manufacturer has: l Selected methods and tools for validation l Created protocols l Performed DQ, IQ, OQ, PQ and documented results l Exerted change control, set revalidation time Validation

Module 1,, Part 5: Review and summary Slide 13 of 13 © WHO – EDM Summary Validation l A quality tool that makes sense l A prevention-based activity l Expensive l In danger of becoming overwhelming l Risk-based assessment of what needs to be validated or verified l The process must be under control Validation