Validation of Active Pharmaceutical Ingredients - Hardcover

Berry, Ira R.; Harpaz, Daniel

Hardcover

ISBN 10: 1574911198 ISBN 13: 9781574911190

Verlag: CRC Press Inc, 2001

Inhaltsangabe

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.

Über diesen Titel

Über die Autorin bzw. den Autor

Ira R. Berry

Details zur Ausgabe

• Verlag: CRC Press Inc
• Erscheinungsdatum: 2001
• Sprache: Englisch
• ISBN 10: 1574911198
• ISBN 13: 9781574911190
• Einband: Gebundene Ausgabe
• Anzahl der Seiten: 618
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: Nicht verfügbar