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Supplementary Training Modules on

Good Manufacturing Practices

Validation

Module 1, Part 1: Introduction and The VMP

Slide 1 of 22

WHO EDM

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

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WHO EDM

Validation
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

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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

Module 1, Part 1: Introduction and The VMP

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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.

Module 1, Part 1: Introduction and The VMP

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Validation
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

Module 1, Part 1: Introduction and The VMP

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Validation
Qualification and
validation work require:

Collaboration of experts

Budget

Meticulous and careful planning

Module 1, Part 1: Introduction and The VMP

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A
Validation
Master
Plan helps
the
manufactur
er and
inspectorat
e

WHO EDM

Validation
The Validation Master
Plan
(VMP)

Philosophy

Content

Strategy

Module 1, Part 1: Introduction and The VMP

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Validation
Validation Master Plan

Recommendation only
Cover manufacturers validation policy and needs

Provides information on validation

It should describe:

why?
what?
where?

organization

by whom?
how?
when?

Module 1, Part 1: Introduction and The VMP

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Validation
Validation Master Plan

Prospective validation

Concurrent validation

Retrospective validation

Revalidation

Change control

Module 1, Part 1: Introduction and The VMP

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Validation
The VMP helps:

Management

Validation team members

Project leaders

GMP inspectors

Module 1, Part 1: Introduction and The VMP

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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

Module 1, Part 1: Introduction and The VMP

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Validation
Validation Activities in VMP

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

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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

Module 1, Part 1: Introduction and The VMP

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WHO EDM

Validation
The Introduction to the VMP

Validation policy

Project scope

Location and timing (including priorities)

Validation procedures

Standards

Module 1, Part 1: Introduction and The VMP

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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

Module 1, Part 1: Introduction and The VMP

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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

Module 1, Part 1: Introduction and The VMP

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WHO EDM

Validation
VMP should contain:

Descriptions of

plant (where to validate)


processes
products
Personnel attributes

expertise and training

Key acceptance criteria

Module 1, Part 1: Introduction and The VMP

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WHO EDM

Validation
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

Module 1, Part 1: Introduction and The VMP

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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

Module 1, Part 1: Introduction and The VMP

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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

Module 1, Part 1: Introduction and The VMP

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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

Module 1, Part 1: Introduction and The VMP

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WHO EDM