Validation Master Plans: Progress of Implementation in the Pharmaceutical Industry

Background: Some international regulatory agencies require that companies develop a validation master plan (VMP) to govern their validation activities, but such a plan is not an explicit requirement of US regulations. This paper examines the progress that US pharmaceutical companies have made to implement VMPs for drug products manufactured and produced in accordance with the US FDA Good Manufacturing Practice for Finished Pharmaceuticals. Methods: A survey instrument was developed using an established framework with a focus on behavior and capability and disseminated electronically to midlevel and senior regulatory and quality professionals concentrated in the US. Results: Responses from 42 senior regulatory professionals showed that VMPs are incorporated into the quality systems of most companies but approaches to implementation differ. Small companies typically employ centralized VMPs whereas larger companies commonly decentralize their VMPs. Companies of all sizes most commonly use paper rather than electronic tools to organize and track validations including validations of equipment. Conclusion: The fact that VMPs are commonly used even when they are not mandated suggests that the VMP is becoming an industry standard and may suggest that global standards are playing a significant role in the quality approaches of US-based companies.