中英文美国FDAGMP检查.pptxVIP

Conducting an FDA Inspection执行FDA检查;Inspections…检查 …;Objectives of Inspection检查的目标;The Law says...法律规定...;The Law says…法律规定...;The CGMP Regulation CGMP法规;The CGMP Regulation CGMP 法规;Conducting an FDA Inspection: Objectives进行FDA检查的目标;Compliance Program Guidance Manual 符合性项目指南手册7356.002 “Drug Manufacturing Inspections” “药品生产检查”;What type of inspection can be done?可以进行什么类型的检查？;Quality 质量;Records记录;Records记录;Records记录;More Records更多的记录;Quality System质量体系;Quality System cont.质量体系 续;Facilities and Equipment System设施和设备系统;Facilities and Equipment System设施和设备系统;Facilities and E