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Validation of Active Pharmaceutical Ingredients Ed by Ira A.Berry and Daniel Harpaz

By: Berry, Ira A.
Contributor(s): Harpaz, Daniel.
Material type: materialTypeLabelBookPublisher: Boca Raton CRC Press 2001Edition: 2nd ed.Description: 588p.ISBN: 9781574911190.Subject(s): PharmaceuticsDDC classification: 615.152
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Item type Current location Collection Call number Status Date due Barcode Item holds
Book Book Institute of Pharmacy
General 615.152 VAL (Browse shelf) Available P0003403
Book Book Institute of Pharmacy
Reference 615.152 VAL (Browse shelf) Not For Loan P0001446
Total holds: 0

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. The second edition is fully revised, updated, and expanded to include new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. New terminology has been introduced and the old terminology has been better defined to improve the understanding of related concepts and principles. With this book, readers gain a working knowledge of the regulatory process that will facilitate their organization's compliance.

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