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% of the applications submitted by foreign pharmaceutical companies are approved each year. This thorough guide provides the needed solutions and guidance for both foreign and U.S. companies to achieve FDA compliance and authorization to market.
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance ebook
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance download
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance reviews
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance free ebook pdf epub
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