Nine steps for creating a Master Validation Plan

When Does a Master Validation Plan Required?

A master validation plan is needed when significant changes are made to the facilities, the equipment and processes which may affect the quality of the product. A risk assessment approach should be used to determine the scope and extent of validation. The master validation plan should be available prior to starting any of the validation activities.

A new master validation plan should be prepared for projects involving major change to existing equipment. A MVP is not required for projects, which involve the installation or alteration of a single item of equipment – these should be documented on separate validation plans and reports.

The master validation plan should be available prior to starting any of the validation activities. For some sites, both a site MVP (for the site’s validation requirements) and project specific MVPs may exist. The site validation committee should provide co-ordination as appropriate.

What Should a Master Validation Plan Contain?

Each master validation plan shall describe the scope of the activities and address relevant key elements of validation affected by the change, indicating the actions and documents that will be needed. The key elements are those factors that can have an effect on product quality.

The MVP shall identify all the components to be included within a validation project. Flow diagrams or matrixes can be useful to provide an overview and monitoring tool. A high level process map or flowchart of the manufacturing process should be included.

Following the issue of the master validation plan, detailed risk assessments (system and component impact assessments) should be carried out to identify items requiring qualification.

The content of the master validation plan should reflect the complexity of the extent of the validation activities to be undertaken. At minimum the MVP should address the following:

1. Title, statement of commitment and approval page.

2. Summary description of the project and its scope.

3. A statement of validation policy and the objectives of the validation activity

4. References to other existing validation documents.

5. A description of the organization and responsibilities for validation

6. The validation strategy to be adopted opposite Facilities and Systems(process equipment and services including automated systems), Materials, Quality Control, Personnel including training.

7. The intent in respect of Process Validation and Cleaning Validation for each of the drug product range.

8. The documentation management and control system to be used.

9. A description of the validation change management process.

10. An indicative relative timescale plan.

11. Clear acceptance criteria against which the outcome of the validation exercise will be judged.

The requirements for the above should be reflected in a completed Responsibility Chart for all deliverable documentation.

For large projects involving many materials, a Materials Validation Plan may be used. For smaller projects, a Materials Validation Plan is optional. The Plan or lower tier documentation alone may cover the qualification of materials. 

The headings of the MVP may be based on the above list. A project may be organized in different ways, however, depending on the character of the project.

The validation plan should demonstrate that the validation activities have been considered and are being organized in a structured manner. 

A master validation plan should be presented as a formal document which is suitable both as an internal guide and for scrutiny by a member of a regulatory inspectorate. It should therefore be concise, easy to read and not excessively duplicate text from documents held elsewhere in the Quality System.

Reporting Requirement for Master Validation Plan

Each validation plan should result in a report confirming that all validation activities have been completed satisfactorily.

It is recommended that a Summary Validation Report (or Master Validation Report) is prepared which summarizes activities undertaken, presents the overall conclusions and provides cross references to any associated reports or follow up actions.

Changes to Master Validation Plan

Master Validation Plan should be prepared and managed by members of the manufacturing site where the exercise is to be carried out and utilize personnel competent for the tasks assigned. Where consultants are used to prepare MVPs, their work should be subject to the same level of scrutiny and approval as in-house documentation.

Any changes from a master validation plan after issue, should be agreed with the steering committee for the project. The MVP should not be revised once the activities it describes have started. The changes should be recorded in the project documents derived from the MVP and be reported in the Master Validation Report.