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biopharmaceuticals biochemistry and biotecnology - Walsh G.

Walsh G. biopharmaceuticals biochemistry and biotecnology - John Wiley & Sons, 2003. - 572 p.
ISBN 0-470-84327-6
Download (direct link): biochemistryandbiotechnology2003.pdf
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Chapter 3
The drug manufacturing process
The manufacture of pharmaceutical substances is one of the most highly regulated and rigorously controlled manufacturing processes known. In order to gain a manufacturing licence, the producer must prove to the regulatory authorities that not only is the product itself safe and effective, but that all aspects of the proposed manufacturing process comply to the highest safety and quality standards. Various elements contribute to the safe manufacture of quality pharmaceutical products. These include:
• the design and layout of the manufacturing facility;
• raw materials utilized in the manufacturing process;
• the manufacturing process itself;
• the training and commitment of personnel involved in all aspects of the manufacturing operation;
• the existence of a regulatory framework which assures the establishment and maintenance of the highest quality standards with regard to all aspects of manufacturing.
This chapter aims to overview the manufacturing process. It concerns itself with four major themes: (a) a description of the infrastructure of a typical manufacturing facility, and some relevant operational issues — much of the detail presented in this section is equally applicable to facilities manufacturing non-biological-based pharmaceutical products; (b) sources of biopharmaceuticals; (c) upstream and downstream processing of biopharmaceutical products; and (d) analysis of the final biopharmaceutical product. Before delving into specific aspects of pharmaceutical manufacturing, various publications, such as international pharmacopoeias and guides to good manufacturing practice for medicinal products, will be discussed. These publications play a central role in establishing criteria which guarantee the consistent production of safe and effective drugs.
INTERNATIONAL PHARMACOPOEIA
Many thousands of pharmaceutical substances are routinely manufactured by the pharmaceutical industry. Two of the most important determinants of final product safety and efficacy are: (a) the standard of raw materials used in the manufacturing process; and (b) the standard (i.e. specification) to which the final product is manufactured. Most pharmaceutical substances are
Biopharmaceuticals: Biochemistry and Biotechnology, Second Edition by Gary Walsh John Wiley & Sons Ltd: ISBN 0 470 84326 8 (ppc), ISBN 0 470 84327 6 (pbk)
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