Module 1, Part 1: Introduction and The VMP Slide 1 of 22
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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
Module 1, Part 1: Introduction and The VMP Slide 2 of 22
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Validation
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Objectives of Part 1
To provide an introduction to the subject of
Validation
To provide information on the Validation
Master Plan
Module 1, Part 1: Introduction and The VMP Slide 3 of 22
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Validation
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Three basic principles of Quality Assurance:
Quality, safety, effectiveness
Cannot inspect quality into a product
Processes must be under control
Module 1, Part 1: Introduction and The VMP Slide 4 of 22
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Validation
WHO validation definition
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The documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the expected results.
Module 1, Part 1: Introduction and The VMP Slide 5 of 22
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Validation
Qualification or validation?
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A system must be qualified to operate in a validated process
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Qualify a system and/or equipment
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Validate a process
Qualification versus validation, e.g. you
qualify an autoclave, whereas you validate a sterilization process
Module 1, Part 1: Introduction and The VMP Slide 6 of 22
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Validation
Qualification and validation work require:
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Collaboration of experts
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Budget
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Meticulous and careful planning
A Validation
Master Plan helps the manufacturer and inspectorate
Module 1, Part 1: Introduction and The VMP Slide 7 of 22
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Validation
Philosophy
Content
Strategy
Module 1, Part 1: Introduction and The VMP Slide 8 of 22
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Validation
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Validation Master Plan
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Recommendation only
Cover manufacturer’s validation policy and needs
Provides information on validation organization
It should describe:
 why?
 what?
 where?
 by whom?
 how?
 when?
Module 1, Part 1: Introduction and The VMP Slide 9 of 22
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Validation
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Validation Master Plan
Prospective validation
Concurrent validation
Retrospective validation
Revalidation
Change control
Module 1, Part 1: Introduction and The VMP Slide 10 of 22
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Validation
The VMP helps:
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Management
Validation team members
Project leaders
GMP inspectors
Module 1, Part 1: Introduction and The VMP Slide 11 of 22
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Validation
The VMP
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Identifies validation items (products, processes, systems)
Defines nature and extent of testing expected
Outlines test procedures and protocols
Summary document
Management agreement
Module 1, Part 1: Introduction and The VMP Slide 12 of 22
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Validation
Validation Activities in VMP
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Every validation activity included
Revalidation
Validation of new process cycles
Large validation projects have separate VMPs
Include reasonable unexpected events
Module 1, Part 1: Introduction and The VMP Slide 13 of 22
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Validation
The VMP:

Enables overview of entire validation project
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Lists items to be validated with the planning schedule as its heart
Is like a map
Module 1, Part 1: Introduction and The VMP Slide 14 of 22
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Validation
The “Introduction” to the VMP
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Validation policy
Project scope
Location and timing (including priorities)
Validation procedures
Standards
Module 1, Part 1: Introduction and The VMP Slide 15 of 22
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Validation
VMP should state who is responsible for:
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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
Module 1, Part 1: Introduction and The VMP Slide 16 of 22
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Validation
VMP should contain:
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Cross references to documents
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Specific process considerations
Specific characteristics briefly outlined
Validation list (What to validate)
 premises, systems and equipment
 processes
 products
Module 1, Part 1: Introduction and The VMP Slide 17 of 22
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Validation
VMP should contain:
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Descriptions of
 plant (where to validate)
 processes
 products
Personnel attributes
 expertise and training
Key acceptance criteria
Module 1, Part 1: Introduction and The VMP Slide 18 of 22
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Validation
VMP should contain:
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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
Module 1, Part 1: Introduction and The VMP Slide 19 of 22
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Validation
VMP should contain change control
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Policy and procedure
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Risk assessment
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Authorization
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Failure to properly document changes to the system means invalidation of the process
Module 1, Part 1: Introduction and The VMP Slide 20 of 22
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Validation
Changes that require revalidation
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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
Module 1, Part 1: Introduction and The VMP Slide 21 of 22
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Validation
In summary, a VMP should contain at least:
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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
Module 1, Part 1: Introduction and The VMP Slide 22 of 22
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