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OverviewTo successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. Topics include: Safety, efficacy, and environmental/regulatory requirements Analysis of the recent movement of API manufacturing from the U.S. and Europe to countries such as India and China The FDA’s intensified foreign inspection program Multi-use and flexible design facilities The shift from maintenance scheduling to built-in reliability This second edition focuses on the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the United States and international regulatory agencies. Full Product DetailsAuthor: Stanley Nusim , Stanley NusimPublisher: Taylor & Francis Inc Imprint: CRC Press Inc Edition: 2nd edition Volume: 205 Dimensions: Width: 15.20cm , Height: 2.50cm , Length: 22.90cm Weight: 0.680kg ISBN: 9781439803363ISBN 10: 1439803366 Pages: 456 Publication Date: 23 December 2009 Audience: Professional and scholarly , Professional & Vocational Format: Hardback Publisher's Status: Active Availability: In Print  This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of ContentsReviewsAuthor InformationStanley Nusim Tab Content 6Author Website:Countries AvailableAll regions |
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