为满足当今FDA GMP和其他国际质量体系要求而进行了全面修订。本省时指南指导您按照当前的法规和法律要求，逐步记录、实施和指导质量体系，从设计概念到采购、制造、检验和测试、分发、安装和维护。包括FDA新的GMP质量体系法规，以及向制造商、分销商、服务机构和FDA检查员提供的官方指导文件副本。威廉·科特里亚（William Cotriar，PE）和劳伦斯·鲍尔（Lawrence Bauer，PhD）是美国质量控制学会（American Society for Quality Control）的研究员，曾担任马尔科姆·鲍德里奇（Malcolm Baldrige）国家质量奖（National Quality Awards）的主考人。

Completely revised for meeting today's FDA GMP and other international quality system requirements. This timesaving guide leads you step-by-step through documenting, implementing, and directing quality systems from design concept through purchasing, manufacturing, inspection and testing, distributing, installing, and servicing according to current regulatory and legal requirements. Includes FDA's new GMP Quality System regulation and copies of official guidance documents to manufacturers, distributors, service organizations, and FDA inspectors. William Cotliar, PE, and Lawrence Bauer, PhD, are fellows of the American Society for Quality Control and have served as examiners on the Malcolm Baldrige National Quality Awards.