Ira R. Berry / Daniel Harpaz (eds.)

Validation of Active Pharmaceutical Ingredients

Herausgeber: Berry, Ira R.; Harpaz, Daniel

• Gebundenes Buch

Produktbeschreibung

Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.

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Produktdetails

• Verlag: CRC Press
• 2nd edition
• Seitenzahl: 620
• Erscheinungstermin: 31. Dezember 2001
• Englisch
• Abmessung: 260mm x 183mm x 38mm
• Gewicht: 1346g
• ISBN-13: 9781574911190
• ISBN-10: 1574911198
• Artikelnr.: 23311939

Autorenporträt

Ira R. Berry

Inhaltsangabe

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.