The document provides an overview of the Validation Master Plan (VMP) as part of good manufacturing practices (GMP) training. It outlines the definition of validation, its principles, objectives, and key components required in a VMP, including responsibilities, planning, scheduling, and change control. The VMP serves as a comprehensive guide for managing validation projects, ensuring quality assurance in processes and systems.

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