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  • 1
    Online Resource
    Online Resource
    Boca Raton :CRC Press,
    UID:
    almahu_9949865805102882
    Format: 1 online resource.
    Edition: First edition.
    ISBN: 9781003284970 , 1003284973 , 9781003814047 , 1003814042 , 9781003814009 , 100381400X
    Series Statement: Drugs and the pharmaceutical sciences
    Content: "The fact that GMP audits in the pharmaceutical and biotechnology industries have to be evaluated and with very limited resources has created a gap in this field. The lack of trained and qualified GMP auditors is on the rise in all organizations which are required to implement FDA, EMA, MHRA, WHO, TGA, PIC/S regulations. This volume is an essential reference source for those organizations operating in the field of health and presents the basic knowledge needed to perform audits. The author also provides useful tips and a selection of samples about GMP audits that are indispensable for professionals and health inspectors working in industry and health authorities"--
    Note: The concept of quality -- GMP audits -- GMP auditing in various areas -- Auditing pharmaceutical quality management system -- Alternative auditing methods -- Audit question examples.
    Additional Edition: Print version: Edik, Mustafa. GMP audits in pharmaceutical and biotechnology industries Boca Raton : CRC Press, 2024 ISBN 9781032257303
    Language: English
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