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

Validation

Supplementary Training Modules on Good Manufacturing Practices

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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

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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

Validation

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Validation

Introduction

Three basic principles of Quality Assurance:

Quality, safety, effectiveness

Cannot inspect quality into a product

Processes must be under control

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Validation

WHO validation definition

The documented act of proving that any

procedure, process, equipment,

material, activity, or system actually

leads to the expected results. 

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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

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Qualification and validation work require:

Collaboration of experts

Budget

Meticulous and careful planning

A Validation

Master Plan helps

the manufactur

er and inspectorat

e

Validation

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Validation

The Validation Master Plan

(VMP)

Philosophy

Content

Strategy

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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?

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Validation

Validation Master Plan

Prospective validation

Concurrent validation

Retrospective validation

Revalidation

Change control

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Validation

The VMP helps:

Management

Validation team members

Project leaders

GMP inspectors

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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

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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

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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

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Validation

The “Introduction” to the VMP Validation policy

Project scope

Location and timing (including priorities)

Validation procedures

Standards

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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

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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

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Validation

VMP should contain: Descriptions of

plant (where to validate) processes products

Personnel attributes expertise and training

Key acceptance criteria

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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

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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

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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

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Validation

In summary, a VMP should contain atleast: 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