Validation Master Plan (VMP), Part 1: Differences in Terminology, Content, and Applications

摘要

This discussion addresses basic considerations associated with the topic of the Validation Master Plan (VMP). While VMP isrna well-known term, its use, structure, and content is not consistent across organizations and in the industry. Organizationsrnmay utilize VMP very differently in their respective sites. Further, alternate VMP terminology may be used in organizations.rnThis discussion identifies four different VMP types commonly used in pharma and related industries. These include siterndocuments, function documents, major project documents, and single project documents. Different terminology, content, andrnapplications in VMPs lead to confusion. Sites should consider developing a procedure that defines VMP and all other termsrnused at their site with consideration for industry and regulatory standards. Such a procedure will unify terminology used byrnpersonnel in the respective areas of the site and help to clarify communications.rnThe site Validation Approval Committee (VAC) has a vital responsibility to the manufacturing site and is critical to the successrnof the site validation program. Whatever structure and content, the site VAC should consider the VMP as their document. ThernVAC should consider themselves to be a surrogate FDA (or other regulatory agency) auditor when they are reviewing VMP.rnClarifying and unifying VMP terminology used at a site should be a joint responsibility of the VMP and the site validationrnfunction. The terminology, content, and applications of VMP should be consistent with industry and regulatory norms andrnexpectations.