The Master Validation Plan is extremely important and essential to any process validation. It is here that you determine the overall approach that you plan to take, the budget, the assumptions, the timeline, etc. This document serves several purposes:
– Secures the priority, authorization, and resources from management to proceed with a validation
– Assures the success of the project through proper planning
– Flushes out and avoids surprise issues in the middle of a validation, by presenting the overall planned approach
– Indicates to an auditor that the company is committed to executing the validation
An MVP is also listed as part of a Validation in the Global Harmonization Task Force guidance.
