设备设施工艺清洗等验证.pdf

题目 题目 验证主计划Validation Master Plan 验证主计划Validation Master Plan 设备验证Equipment validation 设备验证Equipment validation 设施(HVAC, 水) 验证Facilities (HVAC, 设施(HVAC, 水) 验证Facilities (HVAC, water) validation water) validation 工艺验证Process validation 工艺验证Process validation 清洗验证Cleaning validation 清洗验证Cleaning validation 验证定义 验证定义 Definition of Validation Definition of Validation Validation is establishing documented evidence Validation is establishing documented evidence which provides a high degree of assurance that a which provides a high degree of assurance that a specific process will consistently produce a product specific process will consistently produce a product meeting its predetermined specifications and quality meeting its predetermined specifications and quality characteristics. characteristics. “Guidance on General Principles of Process Validation”. “Guidance on General Principles of Process Validation”. Office of Compliance, CDER, FDA, May 1987 Office of Compliance, CDER, FDA, May 1987 联邦法规 联邦法规 21 CFR 211.110(a) 21 CFR 211.110(a) written procedures shall be established and …written procedures shall be established and … followed that describe the in-process controls, followed that describe the in-process controls, and tests, or examinations to be conducted on and tests, or examinations to be conducted on appropriate samples of in-process materials of appropriate samples of in-process materials of each batch. Such control procedures shall be each batch. Such control procedures shall be established to monitor the output and to validate established to monitor the output and to validate the performance of those manufacturing process that may