The Importance Of Validation Master Planning

By Kayla Fouch, Manager, Jordan Krist, Consultant, and Parla Hoelter, Manager Project Farma

A validation master plan (VMP) is a high-level, strategic document designed to outline the key components necessary for the entire commissioning, qualification, validation lifecycle (CQV). Establishing a VMP as early as possible is central to reaping the full benefits of having a single unified plan detailing what deliverables and strategies will be expected at a minimum when planning and executing a validation project.

For many early-stage companies, the value of establishing a VMP alongside other major guidance documents may appear to be overshadowed by more immediate concerns related to achieving speed-to-market. However, the primary utility of a VMP lies in its long-term efficiencies – by creating a framework upon which to build subsequent VPPs, companies position themselves to realize significant returns on time and resourcing as well as a reduction in remedial activities.