Appendix M01 Validation Planning.pdf

Appendix M1

Guideline for Validation Planning

1 Purpose

This is a Guideline for the production of Validation Master Plans (VMPs) and individual Validation Plans (VPs)

for systems or projects. The VMP describes the areas of the company within which validation is to take place

and provides an overview of the planning status. The VP describes in detail how the validation is to be

performed for specific systems. A Validation Master Plan may be used to define the overview plan for a large

project or programme of work under which there may be several individual Validation Plans.

The terms Validation Master Plan and Validation Plan are being used for consistency with other parts of

GAMP, but it is recognized that some companies use equivalent terminology for these documents, such as

Protocol, Policy Document, Validation Guideline, or Method Statement.

2 Scope

Documented validation planning is required for GxP regulated systems. User companies should apply these

Guidelines to Validation Master Plans and Validation Plans. The Guidelines apply to both new and existing

automated systems.

3 Validation Master Plans

3.1 General Guidelines

Overall validation activities should be planned and documented in a Validation Master Plan. This should be a

clear and concise summary document, typically covering:

User company validation policy

Organization of validation activities

Summary of facilities, systems, equipment, or processes to be validated

Documentation structure and formats to be used

Change Control process to be followed

Planning and scheduling

The VMP requires approval by management, and is often subject to regulatory inspection. It is a general plan,

typically covering all production areas and processes, including validation of buildings, equipment, automated

systems, analytical methods, and cleaning.

It may either incorporate or refer to a separate automated system VMP, which should include all systems for

which validation is planned.

The structure of Validation Master Plans will depend on the way the user company is structured and on

company preference and policy. Many companies have a management structure that is organized

hierarchically, and some choose successive planning levels that reflect the way that the company itself is

organized. Figure 3.1 gives an example planning hierarchy.

Figure 3.1:

Planning Hierarchy

Multi-site

Management Plan

Site

VMP Level 1

Areas

VMP Level 2

Systems

At the highest level, relevant activities may be included in a general Management Plan. Within a

manufacturing site, there may be a single VMP for all automated systems on the site (VMP Level 1) and a

number of separate plans for the individual areas on that site (VMP Level 2). For the individual systems within

a given area, a detailed VP would define the activities for validation.

Some companies merge VMP Level 1 and Level 2 into a single plan. Other companies operate with a

collection of Level 2 VMPs, and do not collate them into higher level plans.

3.2 Roles and Responsibilities

Responsibility for Validation Master Planning rests with senior management or Quality Assurance (QA),

depending on company policy and procedure. QA should approve the policies and procedures for automated

system validation, including validation planning. QA are responsible for verifying that Validation Plans, and

proposed validation approach, comply with company quality standards and policies, and meet regulatory

requirements. Facility or area management should also approve VMPs.

The meaning of each approval signature should be defined.

3.3 Contents of the Validation Master Plan

This Section gives example content and structure for a Validation Master Plan.

3.3.1 Introduction and Scope

This Section should contain the following information:

Who produced the document, under what authority and for what purpose

Reference to relevant validation policies and plans, and automated system validation policies and plans

Description of the levels of planning, and the particular level that is being addressed by this plan.

Description and locations of the areas being covered at this level (this may be a plant, building, department,

process, product, or any other appropriate arrangement of systems)

Reference to other relevant documents

The period within which the plan will next be reviewed

3.3.2 Organizational Structure

This Section should give an overview of the organization required for the execution of the VMP:

Definition of roles and responsibilities for this level (such as ownership, technical support and QA)

Identification of these persons by job title or function

3.3.3 GxP Criticality Assessment Process

This Section should describe pr refer to the GxP criticality assessment process. It may include high level

assessment information, or preferably refer to some source of information on this topic, such as a system

inventory. The following should be covered:

The requirement for determining levels of GxP criticality

The procedures for performing the assessment

The current status of the process (recognizing that the assessment may be repeated, and the levels of

criticality updated)

3.3.4 Validation Strategy

This Section should outline overall validation strategy to be applied, referring to the automated system

validation procedures to be followed, and the life cycle model to be applied.

3.3.5 Change Control

This Section should outline the overall requirements for Change Control, including reference to relevant

procedures.

3.3.6 Standard Operating Procedures and Training

This Section should outline how Standard Operating Procedures (SOPs) will be established or updated, and

the subsequent training requirements.

3.3.7 Documentation Management

This Section should define, or refer to, the required document management and control procedures.

3.3.8 Timeline and Resources

This Section gives an outline of the validation timeline, with an indication of the planned end dates for the

validation of relevant areas and the resources to be assigned to each activity.

3.3.9 Glossary

This Section should contain definitions of any terms that may be unfamiliar to the readership of the document.

4 Validation Plans

4.1 General Guidelines

The Validation Plan should summarize the entire project, identify measures for success, and clearly define

criteria for final acceptance. A Validation Plan (VP) should be produced for each automated system, defining:

What activities are required

How they will be performed, and who is responsible

What their output will be

What the requirements are for acceptance

How the validation status will be maintained for the lifetime of the system

A generic or common plan may be used for identical systems. The validation requirements should be

communicated to the supplier at the start of the project.

The plan is used not only to maintain compliance with the requirements for validation of the system but also

provides the basis upon which the project will be reported. There may be a need for a series of reports to be

produced throughout the project. The Validation Plan should take this requirement into account and indicate

the different types of report to be produced covering progress made, issues raised, and acceptance of different

phases of the project.

A Validation Report should also be produced, which summarizes the entire project, measures its ultimate

success, and clearly signifies acceptance of the final solution. Guidelines for Validation Reporting are given in

Appendix M7. The relationship between the Validation Plan and associated reports is illustrated in Figure 4.1.

4.2 Roles and Responsibilities

Responsibility for validation planning rests with the System Owner or Project Manager.

Quality Assurance should have oversight of the process, and are responsible for verifying that Validation

Plans, and proposed validation approach, comply with company quality standards and policies, and meet

regulatory requirements.

The meaning of each approval signature throughout the validation process should be defined.

4.3

Figure 4.1:

Relationship between Planning, the Validation

Process and Reporting

Introduction and

Sc ope

Introduction

and Scope

User Requirements

Specification

Design Review and

Risk Assessment

Organizational

Structure

1.1.1.1.1 Phase by

Phase

Supplier Assessment

Validation Report

Summary of

Results

GxP Criticality

Assessment

Project-specific

Validation Plan

Details of

Execution

Validation

Strategy

Functional

Specification

Validation

Deliverables

Deviation Reporting

& Resolution

Design Specification

Validation

Status

Acceptance

Criteria

System Build

Change Control

Iterative

Training

Process

SOPs and

Training

Maintaining the

Validated State

Documentation

Management

Glossary

Maintaining the

Validated State

Appendices

Glossary

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