Supplementary Training Modules on Good Manufacturing Practice Validation Part 5: Review and summary
Validation Objectives To review: • WHO validation definition • Philosophy of validation • Personnel requirements • Protocol requirements • DQ IQ OQ and PQ summary • Checklist for validation
Validation WHO validation definition • The documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results.
Validation The VMP • The VMP provides a summary of the company’s philosophy, policy, intentions and approach to validation.
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. • written report and conclusion • process and procedures • processing • testing • cleaning procedures
Validation Personnel - Validation team members • Quality Assurance • Engineering • Manufacturing • Other disciplines may be involved depending on the product and process: • laboratory, technical services • research and development, regulatory affairs • clinical • chemical engineering • purchasing/planning
Validation Protocol development (1) • Identification of process • Objective and measurable criteria • Length and duration of the validation • Shifts, equipment • Identification and quality of utilities • Identification of operators and operator training and qualification
Validation Protocol development (2) • Complete description of the process • Relevant specifications and tests • Samples and sampling methods • Special controls or conditions • Process parameters to be monitored • Methods for controlling and monitoring
Validation Protocol development (3) • Objective and subjective criteria used to evaluate the product • Definition of non-conformance • Statistical methods • Maintenance and repairs • Criteria for revalidation • Criteria for change control
Validation GMP Inspector’s check list for validation (1) Check that the manufacturer has: • A VMP and multi-functional team for validation • Planned approach , defined requirements • Identified and described processes • Analyse the amount of validation work to perform
Validation GMP Inspector’s check list for validation (2) Check that the manufacturer has: • Selected methods and tools for validation • Created protocols • Performed DQ, IQ, OQ, PQ and documented results • Exerted change control, set revalidation time
Validation Summary Validation • A quality toolthat makes sense • A prevention-based activity • Expensive • In danger of becoming overwhelming • Risk-based assessment of what needs to be validated or verified • The process must be under control