| Document Type
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BL
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| Record Number
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976923
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| Doc. No
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b731293
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| Main Entry
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Sarker, Dipak K.
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| Title & Author
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Quality systems and controls for pharmaceuticals /\ Dipak K. Sarker.
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| Publication Statement
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Chichester, England ;Hoboken, NJ :: John Wiley & Sons,, ©2008.
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| Page. NO
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1 online resource (xxii, 182 pages)
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| ISBN
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0470056924
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: 0470056932
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: 0470773030
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: 0470773049
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: 9780470056929
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: 9780470056936
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: 9780470773031
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: 9780470773048
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9780470056929
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9780470056936
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| Bibliographies/Indexes
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Includes bibliographical references (pages 169-175) and index.
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| Contents
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Technology transfer and the climate of change -- Quality systems structure and a maximum quality environment -- Validation -- Good manufacturing practices -- Process control via numerical means -- Product verification and the role of qualified personnel -- In-process and on-process QC testing and control -- Applications of QA to new medicinal products and new chemical entities formulation -- New products manufacturing -- Questions and problems -- References.
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| Abstract
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Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models.℗¡. Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, stati.
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| Subject
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Pharmaceutical industry-- Quality control.
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Drug Industry.
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Pharmaceutical Preparations.
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| Subject
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Quality Control.
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Technology, Pharmaceutical.
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BUSINESS ECONOMICS-- Industries-- Pharmaceutical Biotechnology.
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Health Biological Sciences.
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| Subject
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Pharmaceutical industry-- Quality control.
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| Subject
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Pharmacy, Therapeutics, Pharmacology.
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| Dewey Classification
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338.4/76151
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| LC Classification
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RS189.S27 2008eb
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| NLM classification
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2008 M-556
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QV 735S245q 2008
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