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Cleaning Validation Manual - 9781439826607

Un libro in lingua di Haider Syed Imtiaz Asif Erfan Syed Ph.D. edito da Taylor & Francis, 2010

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This book/CD-ROM manual serves the training needs of finished product pharmaceutical manufacturers who need to train workers involved in developing, manufacturing, auditing, and validating biopharmaceuticals. Written in a global context, the formulas for creating plans, SOPs, and validation protocols can be used in any part of the world. Throughout the manual, a pharmaceutical manufacturing site with both sterile and non-sterile operations is used as a case example. The book includes 20 detailed template protocols for cleaning specific types of equipment and stations, illustrated with b&w photos of equipment and cleaning tools. There is also information on how to establish a cleaning validation program, team roles and responsibilities, planning and execution phases, and testing and reporting. Guidelines from various bodies are provided. The CD-ROM contains adaptable training guidelines, written in plain language. The manual can be used by finished pharmaceutical manufacturers, biopharmaceutical manufacturers, biotechnology contract laboratories, and development labs. Haider is a consultant in quality assurance in the pharmaceutical industry. Asif is a quality control manager at a pharmaceutical company. Annotation ©2010 Book News, Inc., Portland, OR (booknews.com)

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