Creating a Master Validation Plan

By : Sami Power

You might be wondering what master validation plan is and how to create one for your organization. This article can help you understanding the principle of master validation plan and what is involved in creating one.

If you are in pharmaceutical business you have already noticed that you need a validation plan for qualifying your equipments, processes, cleaning systems, buildings and facilities. It is a regulatory requirement for you to create one and implement in your site. If you are to make your product safe, pure, effective and identifiable at all times for human use, you definitely need to create an effective MVP.

An effort to define master validation plan (MVP):
MVP is a strategic document which identifies the elements to be validated, the approach to be taken for validation of each element, the organizational responsibilities and the documentation to be produced in order to ensure full consideration is given to product quality aspects. It will show how the separate validation activities are organized and inter-linked. Overall it provides the details and relative timescales for the validation work to be performed.

You have to create standard operating procedures for the preparation of validation documents which are approved by the Quality Assurance.

When does a MVP required:
A MVP 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 MVP should be available prior to starting any of the validation activities

What should a MVP contains?
Each MVP 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 content of the MVP 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.

Reporting requirement for master validation plan:
Each MVP 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.