1. © 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 Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster Tel: +41.22.791.3598 Fax: +41.22.791.4730 World Health Organization E-mail: hietavam@who.int Supplementary Training Modules on Good Manufacturing Practices

2. © WHO – PSM Part 1 Introduction and The Validation Master Plan (VMP) Part 2: Validation principles Part 3: Cleaning validation Part 4: Process validation Part 5: QC-related validation Validation

3. © WHO – PSM Objectives of Part 1 l To provide an introduction to the subject of Validation l To provide information on the Validation Master Plan Validation

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

5. © WHO – PSM 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.

6. © WHO – PSM Qualification or validation? l A system must be qualified to operate in a validated process l Qualify a system and/or equipment l Validate a process l Qualification versus validation, e.g. you qualify an autoclave, whereas you validate a sterilization process Validation

7. © WHO – PSM Qualification and validation work require: l Collaboration of experts l Budget l Meticulous and careful planning A Validation Master Plan helps the manufacturer and inspectorate Validation

8. © WHO – PSM Validation The Validation Master Plan (VMP) l Philosophy l Content l Strategy

9. © WHO – PSM Validation Validation Master Plan l Recommendation only l Cover manufacturers validation policy and needs l Provides information on validation organization l It should describe: ä why? ä what? ä where? ä by whom? ä how? ä when?

10. © WHO – PSM Validation Validation Master Plan l Prospective validation l Concurrent validation l Retrospective validation l Revalidation l Change control

11. © WHO – PSM Validation The VMP helps: l Management l Validation team members l Project leaders l GMP inspectors

12. © WHO – PSM Validation The VMP l Identifies validation items (products, processes, systems) l Defines nature and extent of testing expected l Outlines test procedures and protocols l Summary document l Management agreement

13. © WHO – PSM Validation Activities in VMP l Every validation activity included l Revalidation l Validation of new process cycles l Large validation projects have separate VMPs l Include reasonable unexpected events Validation

14. © WHO – PSM Validation The VMP: l Enables overview of entire validation project l Lists items to be validated with the planning schedule as its heart l Is like a map

15. © WHO – PSM Validation The Introduction to the VMP l Validation policy l Project scope l Location and timing (including priorities) l Validation procedures l Standards

16. © WHO – PSM Validation VMP should state who is responsible for: l Preparing the VMP l The protocols and SOPs l Validation work l Report and document preparation and control l Approval/authorisation of validation protocols and reports in all stages of validation process l Tracking system l Training needs in support of validation

17. © WHO – PSM Validation VMP should contain: l Cross references to documents l Specific process considerations l Specific characteristics briefly outlined l Validation list (What to validate) ä premises, systems and equipment ä processes ä products

18. © WHO – PSM Validation VMP should contain: l Descriptions of ä plant (where to validate) ä processes ä products l Personnel attributes ä expertise and training l Key acceptance criteria

19. © WHO – PSM VMP should contain: l Format for protocols and other documentation l List of relevant SOPs (How) l Planning and scheduling (When) l Location (Where) l Estimate of staffing requirements (Who) l A time plan of the project (When) l Annexes Validation

20. © WHO – PSM Validation VMP should contain change control l Policy and procedure l Risk assessment l Authorization l Failure to properly document changes to the system means invalidation of the process

21. © WHO – PSM Validation Changes that require revalidation l Software changes; Controllers l Site changes; Operational changes l Change of source of material l Change in the process l Significant equipment change l Production area changes l Support system changes

22. © WHO – PSM Validation In summary, a VMP should contain at least: l Validation policy l Organizational structure l Summary of facilities, systems, equipment, processes to be validated l Documentation format for protocols and reports l Planning and scheduling l Change control l Training requirements

23. © WHO – PSM Validation Question no 14 l The equipment has to be __________ before validating the process which uses the equipment.

24. © WHO – PSM Validation Question no 28 l Which document explains the validation policy of the company?