Pharmaceutical Manufacturing Handbook: Regulations And Quality

With material on Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, 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, and personnel training, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. 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. Annotation c2008 Book News, Inc., Portland, OR (booknews.com)

SHAYNE COX GAD, PhD, DABT, ATS, is the Principal of Gad Consulting Services. Dr. Gad has more than thirty years of experience as a toxicologist, statistical consultant, manager, and general consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of twenty-nine books and numerous papers, presentations, and other publications.