Download
1 / 22
230 likes | 257 Views
Explore the essentials of Validation Master Plans, from introduction to implementation, to ensure compliance with Good Manufacturing Practices. Learn the importance of validation activities, protocols, change control, and training needs in this detailed training module.
E N D
Supplementary Training Modules on Good Manufacturing Practices Validation
Validation Part I: Introduction and The Validation Master Plan (VMP) Part 2: Cleaning validation Part 3: Process validation Part 4: QC-related validation Part 5: Review and summary
Validation Objectives of Part 1 • To provide an introduction to the subject of Validation • To provide information on the Validation Master Plan
Validation Introduction Three basic principles of Quality Assurance: • Quality, safety, effectiveness • Cannot inspect quality into a product • Processes must be under control
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 Qualification or validation? • A system must be qualified to operate in a validated process • Qualify a system and/or equipment • Validate a process • Qualification versus validation, e.g. you qualify an autoclave, whereas you validate a sterilization process
Validation Qualification and validation work require: • Collaboration of experts • Budget • Meticulous and careful planning A Validation Master Plan helps the manufacturer and inspectorate
Validation The Validation Master Plan (VMP) • Philosophy • Content • Strategy
Validation Validation Master Plan • Recommendation only • Cover manufacturer’s validation policy and needs • Provides information on validation organization • It should describe: • why? • what? • where? • by whom? • how? • when?
Validation Validation Master Plan • Prospective validation • Concurrent validation • Retrospective validation • Revalidation • Change control
Validation The VMP helps: • Management • Validation team members • Project leaders • GMP inspectors
Validation The VMP • Identifies validation items (products, processes, systems) • Definesnature and extent of testing expected • Outlines test procedures and protocols • Summary document • Management agreement
Validation Validation Activities in VMP • Every validation activity included • Revalidation • Validation of new process cycles • Large validation projects have separate VMPs • Include reasonableunexpected events
Validation The VMP: • Enables overview of entire validation project • Lists items to be validated with the planning schedule as its heart • Is like a map
Validation The “Introduction” to the VMP • Validation policy • Project scope • Location and timing (including priorities) • Validation procedures • Standards
Validation VMP should state who is responsible for: • Preparing the VMP • The protocols and SOPs • Validation work • Report and document preparation and control • Approval/authorisation of validation protocols and reports in all stages of validation process • Tracking system • Training needs in support of validation
Validation VMP should contain: • Cross references to documents • Specific process considerations • Specific characteristicsbriefly outlined • Validation list (What to validate) • premises, systems and equipment • processes • products
Validation VMP should contain: • Descriptions of • plant (where to validate) • processes • products • Personnel attributes • expertise and training • Key acceptance criteria
Validation VMP should contain: • Format for protocols and other documentation • List of relevant SOPs (How) • Planning and scheduling (When) • Location (Where) • Estimate of staffing requirements (Who) • A time plan of the project (When) • Annexes
Validation VMP should contain change control • Policy and procedure • Risk assessment • Authorization • Failure to properly document changes to the system means invalidation of the process
Validation Changes that require revalidation • Software changes;Controllers • Site changes; Operational changes • Change of source of material • Change in the process • Significant equipment change • Production area changes • Support system changes
Validation In summary, a VMP should contain at least: • Validation policy • Organizational structure • Summary of facilities, systems, equipment, processes to be validated • Documentation format for protocols and reports • Planning and scheduling • Change control • Training requirements
