Supplementary Training Modules on
Good Manufacturing Practices
Validations
– part 1
Workshop on
GMP and Quality Assurance of TB products
Kuala Lumpur
Malaysia, 21 – 25 February 2005
Maija Hietava
M.Sci.Pharm
Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and
Pharmaceuticals Cluster
Tel: +41.22.791.3598 Fax: +41.22.791.4730
World Health Organization
E-mail: [email protected]
© WHO – PSM
Validation
Part 1 Introduction and
The Validation Master Plan (VMP)
Part 2: Validation principles
Part 3: Cleaning validation
Part 4: Process validation
Part 5: QC-related validation
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Validation
Objectives of Part 1

To provide an introduction to the subject of
Validation

To provide information on the Validation
Master Plan
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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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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
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Validation
Qualification and validation
work require:

Collaboration of experts

Budget

Meticulous and careful planning
A Validation
Master Plan
helps the
manufacturer
and
inspectorate
© WHO – PSM
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?
 by whom?

what?
 how?

where?
 when?
© WHO – PSM
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
Validation Activities in VMP

Every validation activity included

Revalidation

Validation of new process cycles

Large validation projects have separate VMPs

Include reasonable unexpected events
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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
© WHO – PSM
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

© WHO – PSM
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
© WHO – PSM
Validation
VMP should contain:

Descriptions of

 plant (where to validate)
 processes
 products
Personnel attributes


expertise and training
Key acceptance criteria
© WHO – PSM
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
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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
© WHO – PSM
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
© WHO – PSM
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
© WHO – PSM
Validation
Question no 14

The equipment has to be
__________ before
validating the process which
uses the equipment.
© WHO – PSM
Validation
Question no 28

Which document explains
the validation policy of the
company?
© WHO – PSM
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