Supplementary Training Modules on Good Manufacturing Practice Validation

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

Validation 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 Module 1, , Part 5: Review and summary Slide 2 of 13 © WHO – EDM

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

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

Validation 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 ä ä processing testing cleaning procedures Module 1, , Part 5: Review and summary Slide 5 of 13 © WHO – EDM

Validation Personnel - Validation team members l l Quality Assurance Engineering Manufacturing Other disciplines may be involved depending on the product and process: ä ä ä laboratory, technical services research and development, regulatory affairs clinical chemical engineering purchasing/planning Module 1, , Part 5: Review and summary Slide 6 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 7 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 8 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 9 of 13 © WHO – EDM

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

Validation 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 Module 1, , Part 5: Review and summary Slide 11 of 13 © WHO – EDM

Validation 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 Module 1, , Part 5: Review and summary Slide 12 of 13 © WHO – EDM

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