工艺验证与GMP认证课件.ppt

工艺验证与GMP认证 姚日生 大多数人认为制药工艺验证是美国人“发明的”-此项药品质量技术管控是US 的FDA的Theodore E. Byers 和 Bernard T. Loftus提出的。 The truth is that many of our fundamental concepts of pharmaceutical process validation came to us from “Validation of Manufacturing Processes,” Fourth European Seminar on Quality Control, September 25, 1980, Geneva, Switzerland, and Validation in Practice, edited by H. Sucker, Wissenschaftliche Verlagsegesellschaft, GmbH, Stuttgard, Germany, 1983. 三个关联词 Qualification 确认-针对设施、仪器和设备、原料和产品等， 注重“做的结果”，保证“做的东西正确”。 Validation