Pharmaceutical Master Validation Plan


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The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and related product applications are rejected by the FDA. In fact, only about 2 per cent of the applications submitted by foreign pharmaceutical companies are approved each year. This ...

Pharmaceutical Master Validation Plan 2001, Informa Medical, Boca Raton, FL

ISBN-13: 9781574443301