Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation

Posted By: maxxum

Stanley Nusim (Editor), «Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation»
Informa Healthcare | ISBN 082470293X | Illustrate ed. (May 25, 2005) | PDF | 2.5 Mb | 368 pages

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Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. It offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety. Filling a gap in the literature, this guide covers all the essential information required to effectively plan and execute manufacturing APIs.

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