How to Create a Validation Master Plan?

Validation master plan (VMP) is a high-level document that summarizes the manufacturer’s overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturer’s qualification and validation work programme and defines details of and timelines for the work to be performed, including a statement of the responsibilities of those implementing the plan.

Steps for Creating a Validation Master Plan (VMP

1. Define the scope; equipment, systems, facilities, processes that needs to be validated.

2. Define the validation strategy and approach for each of the items defined under the scope.

3. Define and identify the roles, responsibilities and resources.

4. Define the processes to be followed along with individual deliverables.

5. Define the acceptance criteria for individual validation activities.

6. Define the validation schedule.

7. Integrate the QMS elements such as change management, deviation management and risk management to the validation processes.

8. Obtain review and approval from all stakeholders and top management so that everyone commits to implement the established plan as per the schedule.


Resource Person: Uchira Lakshan

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