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Quality systems and controls for pharmaceuticals

Author: Dipak K Sarker
Publisher: Chichester, England ; Hoboken, NJ : John Wiley & Sons, ©2008.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:
"Quality Systems and Controls 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  Read more...
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Details

Genre/Form: Handbooks
Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Dipak K Sarker
ISBN: 0470056924 9780470056929 0470056932 9780470056936
OCLC Number: 225389043
Description: xxii, 182 pages ; 25 cm
Contents: 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.
Responsibility: Dipak K. Sarker.
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Abstract:

In today's global marketplace, particular problems can arise when limited control is exercised over new and high-risk medicines. Providing a multidisciplinary approach, Quality Systems and Control  Read more...

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