Validation

1. Module 1, Part 1: Introduction and The VMP Slide 1 of 22 © WHO – EDM
Validation
Supplementary Training Modules on
Good Manufacturing Practices

2. Module 1, Part 1: Introduction and The VMP Slide 2 of 22 © WHO – EDM
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

3. Module 1, Part 1: Introduction and The VMP Slide 3 of 22 © WHO – EDM
Objectives of Part 1
 To provide an introduction to the subject of
Validation
 To provide information on the Validation
Master Plan
Validation

4. Module 1, Part 1: Introduction and The VMP Slide 4 of 22 © WHO – EDM
Validation
Introduction
Three basic principles of Quality Assurance:
 Quality, safety, effectiveness
 Cannot inspect quality into a product
 Processes must be under control

5. Module 1, Part 1: Introduction and The VMP Slide 5 of 22 © WHO – EDM
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. Module 1, Part 1: Introduction and The VMP Slide 6 of 22 © WHO – EDM
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

7. Module 1, Part 1: Introduction and The VMP Slide 7 of 22 © WHO – EDM
Qualification and validation
work require:
 Collaboration of experts
 Budget
 Meticulous and careful planning
A Validation
Master Plan
helps the
manufacturer
and
inspectorate
Validation

8. Module 1, Part 1: Introduction and The VMP Slide 8 of 22 © WHO – EDM
Validation
The Validation Master Plan
(VMP)
 Philosophy
 Content
 Strategy

9. Module 1, Part 1: Introduction and The VMP Slide 9 of 22 © WHO – EDM
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. Module 1, Part 1: Introduction and The VMP Slide 10 of 22 © WHO – EDM
Validation
Validation Master Plan
 Prospective validation
 Concurrent validation
 Retrospective validation
 Revalidation
 Change control

11. Module 1, Part 1: Introduction and The VMP Slide 11 of 22 © WHO – EDM
Validation
The VMP helps:
 Management
 Validation team members
 Project leaders
 GMP inspectors

12. Module 1, Part 1: Introduction and The VMP Slide 12 of 22 © WHO – EDM
Validation
The VMP
 Identifies validation items (products, processes,
systems)
 Defines nature and extent of testing expected
 Outlines test procedures and protocols
 Summary document
 Management agreement

13. Module 1, Part 1: Introduction and The VMP Slide 13 of 22 © WHO – EDM
Validation Activities in VMP
 Every validation activity included
 Revalidation
 Validation of new process cycles
 Large validation projects have separate VMPs
 Include reasonable unexpected events
Validation

14. Module 1, Part 1: Introduction and The VMP Slide 14 of 22 © WHO – EDM
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. Module 1, Part 1: Introduction and The VMP Slide 15 of 22 © WHO – EDM
Validation
The “Introduction” to the VMP
 Validation policy
 Project scope
 Location and timing (including priorities)
 Validation procedures
 Standards

16. Module 1, Part 1: Introduction and The VMP Slide 16 of 22 © WHO – EDM
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. Module 1, Part 1: Introduction and The VMP Slide 17 of 22 © WHO – EDM
Validation
VMP should contain:
 Cross references to documents
 Specific process considerations
 Specific characteristics briefly outlined
 Validation list (What to validate)
 premises, systems and equipment
 processes
 products

18. Module 1, Part 1: Introduction and The VMP Slide 18 of 22 © WHO – EDM
Validation
VMP should contain:
 Descriptions of
 plant (where to validate)
 processes
 products
 Personnel attributes
 expertise and training
 Key acceptance criteria

19. Module 1, Part 1: Introduction and The VMP Slide 19 of 22 © WHO – EDM
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

20. Module 1, Part 1: Introduction and The VMP Slide 20 of 22 © WHO – EDM
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. Module 1, Part 1: Introduction and The VMP Slide 21 of 22 © WHO – EDM
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. Module 1, Part 1: Introduction and The VMP Slide 22 of 22 © WHO – EDM
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