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© WHO – PSM Validations –part 2 Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 2005 Maija Hietava M.Sci.Pharm Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster Tel: Fax: World Health Organization Supplementary Training modules on Good Manufacturing Practices
© WHO – PSM 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 principles
© WHO – PSM 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
© WHO – PSM The VMP l The VMP provides a summary of the company s philosophy, policy, intentions and approach to validation. Validation
© WHO – PSM 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
© WHO – PSM Quality is designed and built into the process/method/premises Functionality, consistency and repeatability is confirmed by validation Validation
© WHO – PSM Validation as such does not improve the process but it Confirms and assures that the process Has been well developed It is well maintained It operates as it should Validation
© WHO – PSM Advantages of validation: During the process the knowledge of process increases Assures the repeatability of the process Assures the fluency of production Assures that the product is continuously according to the marketing authorisation Decreases the risk of the manufacturing problems Decreases the expenses caused by the failures in production Decreases the risks of failing in GMP Decreases the expenses of the every day production even though the validation itself will create expenses Validation
© WHO – PSM 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
© WHO – PSM 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
© WHO – PSM WBS/Validation of new premises VALIDATION Clean area Premises Manufacturing Processes Equipment Manufacturing Support Syst. Utility Systems Analytical Methods Personnel Training Aseptic Processing In-Process Control - HVAC System - LAF Units - Cold Storage - Env. Monitoring - Facility Cleaning - Transfer hatches - Verifi. of classific. - Water systems - Plant Steam - Pure/Clean Steam - Process Gases - Sterilizers - Depyrogenators - SIP Systems - CIP Systems - Washing - Waste Systems - Fermentors - Scales - Incubators - Filtration Units - Filling Equipment - Computerised systems - Fermentation - Separation - Purification - Filtration - Filling Packaging & Labeling - Media Fills- Packaging - Labeling - Process Measurem. - Visual Inspection - Label Control - Sampling - GMP - Gpwning valid.. - SOPs - Equipment - Processes - Chemical - Cleaning valid - Physical - Sterility tests - Biological - Stability
© WHO – PSM 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
© WHO – PSM 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
© WHO – PSM Validation
© WHO – PSM GMP Inspectors 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
© WHO – PSM GMP Inspectors 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
© WHO – PSM Summary Validation l A quality tool that makes lot of sense l A prevention-based activity= important part of quality building process l Expensive in the beginning later will "save the money back" 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 as such does not improve the process l Logical entity: protocol + procedure + report Validation
© WHO – PSM Question no l What are the three important parameters confirmed by validation? Validation
© WHO – PSM Validations – part 1 Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 2005 Maija Hietava M.Sci.Pharm.
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