The Master Validation Plan (MVP) is a universally required document in regulated manufacturing industries, and often the first document requested in a regulatory audit. Virtually all pharmaceutical, medical device, and related healthcare manufacturing industries have some type of MVP in their facility.
Despite widespread awareness of MVP, few MVPs have the same structures content, understanding, or application. The MVP to certain individuals is not the same as the MVP to others. Validation managers comment about frustration with inconsistent terms used in MVP between industries, between companies, between various functional groups within the same organization. MVP is widely known in general, but specifics are not universally consistent.
Created by an industry expert for one of IVT Network's events, the Master Validation Plan SOP and Approval Template will help get your team compliant and consistent! It includes an overview description of MVP and applications implemented by various organizations, an actual MVP form that would be approved by relevant groups in the organization, and an SOP providing directions to create the MVP.
The Master Validation Plan Approval Form provides an example structured MVP document that would be approved by all key functions in an organization. The MVP provides basic physical plant information, manufacturing process flow, validation approach, and other site information. The sections of the example MVP include Manufacturing, Engineering, R&D, QA, and other relevant organizations. Components of these sections are described.
The Master Validation Plan SOP Form provides an example SOP for development of the MVP. It describes each functional element of the MVP to be used by functional areas in the organization. Additional basic elements such as the signature list, roles and responsibilities, revision history, and other sections are described. The Master Validation SOP is a prerequisite for creation and development of the Master Validation Plan.
The article “Master Validation Plan (MVP), Part 1. Differences in Terminology, Content, and Applications” provides basic considerations associated with the topic of the MVP. This expert discussion identifies four different MVP types commonly used in pharma and related industries. These include site documents, function documents, major project documents, and single project documents. Additional MVP documents are planned for publication in the Journal of Validation Technology.