This newly-revised and specifically American edition of the best-selling original is the perfect introduction Good Manufacturing Practice (GMP) as it relates to manufacturing sterile products. Quality Rules in Sterile Products Manufacture is the ideal training resource for workers recently hired into the pharmaceutical, chemical, biotechnology, and bulk pharmaceutical industries. The central tool for many corporations' introductory training, retraining, and reinforcement programs, it covers all the sterile products GMP concepts required by the US FDA, the British MCA, and the European GMPs. In a simple, no-nonsense manner, the author explains the rationale of GMP and the key role played by workers in the production and packaging of pure, safe, and quality sterile products.