Validation of Active Pharmaceutical Ingredients

Contributor(s):

Material type: Text

TextPublication details: Boca Raton CRC Press 2001Edition: 2nd edDescription: 588pISBN:

9781574911190

Subject(s):

Pharmaceutics

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	NIMA Knowledge Centre	9th Floor Reading Zone	General	615.152 VAL (Browse shelf(Opens below))	Available		P0003403
Reference Book	NIMA Knowledge Centre	6th Floor Silence Zone	Reference	615.152 VAL (Browse shelf(Opens below))	Not For Loan		P0001446

Total holds: 0

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Previous	615.152 SHA Quality in the Manufacture of Medicines and other Healthcare Products	615.152 SHA SOP Guidelines	615.152 SHA Validation in Pharmaceutical Industry	615.152 VAL Validation of Active Pharmaceutical Ingredients	615.152 VAL Validation of Pharmaceutical Processes: Sterile Products	615.152 WIL Good Manufacturing Practices For Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer	615.18 AMI A Measurement of Clinical Effectiveness and Cost-Effectiveness of Seasonal Influenza Vaccination in North American Population	Next

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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