Pharmaceutical manufacturing handbook; regulations and quality.9780470259597 Pharmaceutical manufacturing handbook; regulations and quality. Ed. by Shayne Cox Gad. John Wiley John Wiley may refer to:
2008 841 pages $195.00 Hardcover RS192 With material on Food and Drug Administration regulations, international regulations, good manufacturing practices Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. , and process analytical technology Process Analytical Technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters and quality attributes. , this handbook covers the regulations and quality control issues that govern pharmaceutical manufacturing. The book also discusses quality assurance and validation, drug stability, contamination control Procedures to avoid, reduce, remove, or render harmless (temporarily or permanently) nuclear, biological, and chemical contamination for the purpose of maintaining or enhancing the efficient conduct of military operations. , and personnel training, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines guidelines, n.pl a set of standards, criteria, or specifications to be used or followed in the performance of certain tasks. . The full range of the manufacturing cycle is covered, from preformulation of a product to identification of sources of contamination and assessment of stability. The handbook, part of a two-volume set, will be useful to scientists, engineers, and managers involved in pharmaceutical manufacturing. Gad, a consultant, is the author of 29 books. ([c]20082005 Book News, Inc., Portland, OR) |
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