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Validation of Active Pharmaceutical Ingredients

Contributor(s): Material type: TextTextPublication details: Boca Raton CRC Press 2001Edition: 2nd edDescription: 588pISBN:
  • 9781574911190
Subject(s): DDC classification:
  • 615.152 VAL
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Holdings
Item type Current library Item location Collection Call number Status Date due Barcode Item holds
Book Book NIMA Knowledge Centre 9th Floor Reading Zone General 615.152 VAL (Browse shelf(Opens below)) Available P0003403
Reference Book Reference Book NIMA Knowledge Centre 6th Floor Silence Zone Reference 615.152 VAL (Browse shelf(Opens below)) 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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