A Validation Master Plan (VMP) serves as a high-level, strategic document that provides a comprehensive roadmap for validation activities within pharmaceutical drug manufacturing operations. Its primary purpose is to establish a structured approach to validation, ensuring compliance with regulatory requirements such as 21 CFR Part 211 and EU GMP Annex 15. The VMP defines the scope, objectives, and responsibilities for validation efforts, while aligning them with the overarching goals of product quality, patient safety, and regulatory compliance.
A VMP is considered a “living” document. Its dynamic nature allowsit to evolve with the changing landscape of validation activities,regulatory requirements, and operational realities. This continuousreview and updating process ensures that the VMP remainsrelevant and effective in guiding validation efforts, maintainingcompliance, and aligning with the organization’s quality goals.
As the validation process progresses and changes occur in themanufacturing environment, the VMP is revised to reflect theseupdates. This adaptability is crucial for ongoing compliance andalignment with the organization’s quality objectives. By being aliving document, the VMP can effectively respond to newchallenges and opportunities, ensuring that the validation processremains robust and up to date.
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