1. Supplementary Training Modules on Good Manufacturing Practices Validation

2. 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

3. Validation Objectives of Part 1 • To provide an introduction to the subject of Validation • To provide information on the Validation Master Plan

4. Validation Introduction Three basic principles of Quality Assurance: • Quality, safety, effectiveness • Cannot inspect quality into a product • Processes must be under control

5. Validation WHO validation definition • The documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the expected results.

6. 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

7. Validation Qualification and validation work require: • Collaboration of experts • Budget • Meticulous and careful planning A Validation Master Plan helps the manufacturer and inspectorate

8. Validation The Validation Master Plan (VMP) • Philosophy • Content • Strategy

9. 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?

10. Validation Validation Master Plan • Prospective validation • Concurrent validation • Retrospective validation • Revalidation • Change control

11. Validation The VMP helps: • Management • Validation team members • Project leaders • GMP inspectors

12. Validation The VMP • Identifies validation items (products, processes, systems) • Definesnature and extent of testing expected • Outlines test procedures and protocols • Summary document • Management agreement

13. Validation Validation Activities in VMP • Every validation activity included • Revalidation • Validation of new process cycles • Large validation projects have separate VMPs • Include reasonableunexpected events

14. 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

15. Validation The “Introduction” to the VMP • Validation policy • Project scope • Location and timing (including priorities) • Validation procedures • Standards

16. 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

17. 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

18. Validation VMP should contain: • Descriptions of • plant (where to validate) • processes • products • Personnel attributes • expertise and training • Key acceptance criteria

19. 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

20. 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

21. 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

22. 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