林旭清洁验证培训稿

ntific evidence that a process is capable of consistently delivering quality products. (Guidance for Industry Process Validation: General Principles and Practices 2011)清洁验证-Cleaning validationSlide 9河北省食品药品监督管理局?欧盟cGMP 验证定义:Action of proving, in accordance with the principles of GMP, that any procedure, process equipment, material, activity of system actually leads to the expected results通过符合GMP原则的活动来证明任何程序,工艺设备,物料,系统活动实际上会导致预期的结果备注:QUALIFICATIONAction of proving that any equipment works correctly and actually leads to the expected results. The word validation is sometimes widened to incorporate the concept of qualificationGMP验证的定义(2)清洁验证-Cleaning validationSlide 10河北省食品药品监督管理局?CFDA GMP(2010修订版)验证定义:(三十二)确认证明厂房、设施、设备能正确运行并可达到预期结果的一系列活动。(三十八)验证证明任何操作规程(或方法)、生产工艺或系统能够达到预期结果的一系列活动。GMP验证的定义(3)