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Quality Systems and Controls for Pharmaceuticals Book

Quality Systems and Controls for Pharmaceuticals
Quality Systems and Controls for Pharmaceuticals, , Quality Systems and Controls for Pharmaceuticals has a rating of 4 stars
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Quality Systems and Controls for Pharmaceuticals, , Quality Systems and Controls for Pharmaceuticals
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Digital Copy
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  • Quality Systems and Controls for Pharmaceuticals
  • Written by author Dipak Kumar Sarker
  • Published by Wiley, John & Sons, Incorporated, October 2008
  • 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 man
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Book Categories

Authors

Sect. A Most suitable environment 1

1 Introduction 3

2 Technology transfer and the climate of change 11

3 Quality systems structure and a maximum quality environment 15

Sect. B Setting process boundaries 29

4 Validation 31

5 Good manufacturing practices 57

6 Process control via numerical means 97

7 Product verification and the role of qualified personnel 111

8 In-process and on-process QC testing and control 119

Sect. C Starting from scratch 131

9 Applications of QA to new medicinal products and new chemical entities formulation 133

10 New products manufacturing 137

11 Questions and problems 151

References 169

Index 177


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