Validation master plans: Progress of implementation within the pharmaceutical industry

This paper presents the materials necessary for qualifying the researcher's study in partial fulfillment of the requirements for the Doctoral Degree of Regulatory Science at the University of Southern California. The research that it describes examined the progress of implementation of validation master plans (VMPs) in U.S. pharmaceutical companies that manufacture and produce drug products in accordance with the U.S. FDA Good Manufacturing Practice for Finished Pharmaceuticals. The study began with a literature review to gain insight into the evolution of thinking with respect to manufacturing and equipment validation and the current expectations regarding the implementation of VMPs. It introduced a combined framework with a focus on behavior and capability that was used to guide the analysis of the progress and problems that are perceived by industry in the implementation of VMPs. A survey of 42 senior regulatory professionals showed that VMPs are incorporated into the quality systems of most companies, but those companies differ in their approaches to implementation. Small companies typically employ centralized VMPs whereas larger companies commonly decentralize their VMPs Both large and small companies most commonly use documentation systems that still rely heavily on paper rather than electronic tools to organize and track validations including validations of equipment. Their VMPs generally have established retention policies that reduce the reliance of companies on the memories of individuals. Results suggest that VMPs are commonly used in US companies even when such systems are not mandated by US regulation.