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Publisher: Taylor & Francis Group
Focusing on the three overall activities that bring an API to market--process development, manufacturing, and governmental regulation and approval--this guide compiles a wide range of information for 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/assurance, and validation, as well as plant manufacturing activities such as materials management and facility maintenance and safety.Nuslim, S. is the author of 'Active Pharmaceutical Ingredients Development, Manufacturing, and Regulation' with ISBN 9780824702939 and ISBN 082470293X.
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