[share_ebook] Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation (Drugs and the Pharmaceutical Sciences)


Author: Stanley Nusim

Date: 2005-05-25

ISBN: 082470293X

Pages: 368

Language: English

Publisher: Informa Healthcare

Category: Study


Posted on 2011-07-15, by LionFar.

Description


Title:Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation (Drugs and the Pharmaceutical Sciences)
Author:Stanley Nusim
Publisher:Informa Healthcare
ISBN:082470293X
ISBN13:
Date2005-05-25
Pages:368
Language:English
Format: PDF
Size:8.7 MB

Description: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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