Active Pharmaceutical Ingredients, Second Edition: Development, Manufacturing, and Regulation

Active Pharmaceutical Ingredients, Second Edition: Development, Manufacturing, and Regulation

by Stanley Nusim, Nusim Nusim
     
 

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

Overview

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.

Product Details

ISBN-13:
9780824702939
Publisher:
Taylor & Francis
Publication date:
05/28/2005
Series:
Drugs and the Pharmaceutical Sciences Series, #205
Pages:
368
Product dimensions:
9.00(w) x 6.20(h) x 0.90(d)

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