Validation of Active Pharmaceutical Ingredients
Author:   Ira R. Berry ,  Daniel Harpaz (Harpaz Consulting Services, Suffern, New York, USA)
Publisher:   Taylor & Francis Inc
Edition:   2nd Revised edition
ISBN:  

9781574911190


Pages:   618
Publication Date:   31 December 2001
Format:   Hardback
Availability:   In Print   Availability explained
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Validation of Active Pharmaceutical Ingredients


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Author:   Ira R. Berry ,  Daniel Harpaz (Harpaz Consulting Services, Suffern, New York, USA)
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Edition:   2nd Revised edition
Dimensions:   Width: 17.80cm , Height: 3.50cm , Length: 25.40cm
Weight:   1.300kg
ISBN:  

9781574911190


ISBN 10:   1574911198
Pages:   618
Publication Date:   31 December 2001
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print   Availability explained
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 Contents

Introduction. The Legal Framework for the Regulation of APIs. The Legal Basis for Validation. Drug Master Files. FDA's Perspectives on API Manufacturing, cGMP Controls & Validation. Domestic & Foreign API Manufacturing Facility Audits & Findings. Validation of APIs: Case Study. API Validation. Impurities in Drug Substances & Products. Investigating Process Deviations. Technology Transfer. Postapproval Changes. Vendor Qualification & Certification. QA Systems. Cleaning for API Manufacturing Facilities. Validation of Sterile APIs. Validation of Biotechnology APIs. Microbiological Attributes of APIs. Excipients.

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Ira R. Berry

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