ISBN 9780824702939,Active Pharmaceutical Ingredients: Development, Manufacturing & Regulation

Active Pharmaceutical Ingredients: Development, Manufacturing & Regulation

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ISBN 9780824702939
Publisher

Routledge a Taylor & Francis Group

Publication Year 2005
ISBN-13

ISBN 9780824702939

ISBN-10 082470293X
Binding

Hard Back

Edition 2nd
Number of Pages 368 Pages
Language (English)
Subject

Pharmaceutical technology

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.

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. This guide 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.
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