Regulations set forth by the FDA establish an expectation that all aspects of a regulated manufacturing process are well-established, documented, and controlled to ensure consistent high-quality products.
The Validation Master Plan (VMP) is critical in achieving this goal by documenting compliance requirements and explaining necessary validation activities across a manufacturing operation.
Unlike a written plan for a specific validation project, the VMP functions at the top layer control, establishing a defined approach to all validation activities and describing the risk-based strategy for achieving and maintaining a fully-qualified facility supported by all necessity validated processes.
Read on for a practical definition of a VMP, its purpose, its key components, a checklist for evaluation or development, and more.
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