Understanding Validation Master Plans

As part of the "Validation Essentials" webinar, Paul Pluta, Ph.D., explained the importance of robust and comprehensive validation master plans. As Dr. Pluta discussed, validation master plans should describe a company's general validation approach from design and development through continuous improvement. The validation master plan should consist of a program description at the site along with chapters or individual validation master plans for each area of validation (e.g., process, equipment, cleaning, computer). Furthermore, Dr. Pluta said, the validation master plan must be continually updated for regulatory inspections and audits. In this presentation, Dr. Pluta discussed the purpose of a validation master plan, the necessary contents of such a document, and provides an outline of a validation master plan chapter on cleaning validation.

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