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Validation

Supplementary Training Modules onGood Manufacturing Practices

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Part I: Introduction andThe 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. youqualify an autoclave, whereas you validatea sterilization process

Validation

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Qualification and validationwork require:

Collaboration of experts

Budget

Meticulous and careful planning

A Validation

Master Planhelps the

manufacturerand

inspectorate

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 manufacturers validation policy and needs

Provides information on validationorganization

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 planningschedule 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 thesystem 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 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