DECEMBER 2008

PREPARATION OF VALIDATION MASTER

PLAN
PREPARATION OF VALIDATION MASTER PLAN DECEMBER 2008

1. Principle

1.1 Validation in general requires a meticulous preparation and

careful planning of the various steps in the process. In addition,
all work involved should be carried out in a structured way
according to formally authorised standardised working and
administrative procedures. In addition validation is
characterised by:

- Multidisciplinary approach: A specific characteristic of

validation work is that it requires the collaboration of experts
of various disciplines such as pharmacists, technologists,
metrologists, chemical analysts, microbiologists, engineers,
experts on Q.A. validation etc.

- Time constraints: Generally validation work is submitted to

rigorous time schedules. These studies are always the last
stage prior to taking new processes, facilities into routine
operation.

- Costs: Validation studies are costly as they require time of

highly specialised personnel and expensive technology.

1.2 The above factors require a well organised and structured

approach that should be adequately described in a Validation
Master Plan (VMP).

2. Purpose and Definition

Purpose

2.1 The VMP should present an overview of the entire validation

operation, its organisational structure, its content and planning.
The core of the VMP being the list / inventory of the items to be
validated and the planning schedule.

2.2 A VMP helps management:

- to know what the validation programme involves with
respect to time, people and money, and to
- understand the necessity for the programme;
A VMP helps all members of the validation team:
- to know their tasks and responsibilities.

A VMP helps GMP auditors:

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- to understand the firm's approach to validation and the
set up and organisation of all validation activities.

3. Definition

3.1 A Validation Master Plan is a document that summarises the

firm's overall philosophy, intentions and approach to be used for
establishing performance adequacy.

4. Scope

4.1 All validation activities relating to critical technical operations,

relevant to product and process controls within a firm should be
included in a VMP. This includes qualification of critical
manufacturing and control equipment.

4.2 It should comprise all Prospective, Concurrent, Retrospective

Validations as well as Re-validations.

4.3 In case of large projects like the construction of a new facility,

often the best approach is to create a separate VMP. (In such
situations the VMP should be part of the total project
management.)

5. Format and Content

5.1 The VMP should be a summary document and should therefore

be brief, concise and clear. It should not repeat information
documented elsewhere but refer to existing documents such as
Policy Documents, SOP's and Validation Protocols/Reports.
The VMP should be agreed by management.

5.2 A VMP should contain data on the following subjects / proposed

chapters.

Introduction:

5.2.1 Firm's validation policy, general description of the scope

of those operations covered by the VMP, location and
schedule (including priorities).

Organisational Structure of All Validation Activities:

5.2.2 Personnel responsibility for

- the VMP,
- protocols of individual validation projects,

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- validation work,
- report and document preparation and control,
- approval / authorisation of validation protocols and
reports in all stages of validation processes,
- tracking system for reference and review,
- training needs in support of validation.

Plant / Process / Product Description:

5.2.3 Provides a cross reference to other documents. A

rationale for the inclusion or exclusion of validations, for
the validation approach and the extent of validation
should be included.

Note: A common principle in validation studies is to

challenge processes, systems etc. The rationale
behind any challenge and or “worst case” situation
should be explained. Consideration can be given
to the grouping of products / processes for the
purpose of validating "worst case" situations.
Where "worst case" situations cannot be
simulated, the rationale for the groupings made
should be defined.

Specific Process Considerations:

5.2.4 Under this heading specific characteristics / requirements

of the plant / process etc. that are critical for yielding a
quality product and need extra attention may be briefly
outlined here.

List of Products / Processes / Systems to be Validated:

5.2.5 All validation activities comprised in the VMP should be

summarised and compiled in a matrix format. Such matrix
should provide an overview and contain:
- all items covered by the VMP that are subject to
validation describing the extent of validation required
[i.e. IQ, OQ and/or PQ]. It should include validation of
analytical techniques which are to be used in
determining the validation status of other processes or
systems,
- the validation approach, i.e. Prospective,
Retrospective or Concurrent,
- the Re-validation activities,
- actual status and future planning.

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Key Acceptance Criteria:

5.2.6 General statement on key acceptance criteria for the

items listed under (5.2.5) above.

Documentation Format:

5.2.7 The format to be used for protocols and reports should be

described or referred to.

Required SOP's:

5.2.8 List of relevant SOP's should be presented.

Planning & Scheduling:

5.2.9 An estimate of staffing (including training needs),

equipment and other specific requirements to complete
the validation effort should be described in the VMP. A
time plan of the project with detailed planning of
subprojects. This time plan could be included in the
above mentioned matrix (5.2.5). A VMP requires regular
updating.

Change Control:

5.2.10 A statement of the company's commitment to controlling

critical changes to materials, facilities, equipment or
processes (including analytical techniques), should be
included.

6.0 References

PIC/S document PI 006-3 : Recommendations on Validation Master

Plan, Installation and Operational Qualification, Non-Sterile Process
Validation, Cleaning Validation.

END OF DOCUMENT

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Contact Officer:

Jessica Teo
GMP Audit Branch
Manufacturing & Quality Audit Division
Health Products Regulation Group
Health Sciences Authority

150 Cantonment Road, Cantonment Centre,

Block A #01-02 Singapore 089762
www.hsa.gov.sg

T: 68663509
F: 64789068

Goh Choon Wee

GMP Audit Branch
Manufacturing & Quality Audit Division
Health Products Regulation Group
Health Sciences Authority

150 Cantonment Road, Cantonment Centre,

Block A #01-02 Singapore 089762
www.hsa.gov.sg

T: 68663520
F: 64789068