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S. Haider – Pharmaceutical Master Validation Plan

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 approv  

Wydawnictwo:
CRC Press
ISBN:
1574443305

liczba stron:
208

kategoria:
zdrowie, medycyna

język:
polski

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