The Validation Master Plan

12-point Checklist & Regulation Summary

Recently a QA manager in a pharmaceutical company asked our Regulatory Compliance Experts about how to create a Validation Master Plan. In this article we outline the guidance in US and EU, and offer links to references that can help you build and improve your VMP.

In the US, a Validation Master Plan is not technically a regulatory requirement; in the EU, it is.  For the US, the actual regulatory requirement is that you have a clearly defined and documented validation program.  In EU,  you are subject to receiving a note of deficiency if you don't have a Validation Master Plan in place. In both areas, even if you have documents that are equivalent to a Validation Master Plan, it's preferred to have them in a master document.