Good Manufacturing Practices for Pharmaceuticals

✍ Scribed by Graham P. Bunn (Editor)

Publisher: CRC Press
Year: 2019
Tongue: English
Leaves: 387
Series: Drugs and the Pharmaceutical Sciences: A Series of Textbooks and Monographs
Edition: 7th
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.

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Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holdings of DrugsFinished Pharmaceuticals: General Provisions (Subpart A)Organization and Personnel: (Subpart B)Buildings and Facilities: (Subpart C)Equipment: (Subpart D)