Validation Master Plan

How does the validation master plan relate with the other validation activities? Is it a general template from which the other validation works (e.g., process validation, cleaning validation) will arise from? (I am sorry for such a general question, that maybe everyone else already knows). Thank you very much!

The Validation Master Plan (VMP) – sometimes called Master Validation Plan (MVP) – the name really doesn’t matter - is the roadmap for all (non-product) validation activities.

The plan outlines the company operations, identifying what’s in scope for validation and what’s out of scope.

For example, the company may be doing commercial work only on one manufacturing line and they could exempt all the processes and equipment used on that line.

The VMP is used to establish how you take a risk-based approach to your validation activities.

We’ll talk a bit more about that later.

The VMP is often used to describe the structure of your validation program. You may recall the discussion regarding IQ/OQ/PQ – activities may be done in one or another qualification; the company just needs to be consistent. This is the place to establish the consistency.

The VMP should cover the entire facility. This enables the identification of inclusions and exclusions as mentioned above. It also enables facility-wide applications like HVAC, electricity, etc. to be assessed and an approach to validation established.