完整性测试剖析.ppt

密理博中国有限公司 生物制药工艺部 Content 讲座目录 What is filter integrity? 什么是滤膜完整性? Why Integrity Test? 为什么做完整性测试? Regulations about integrity test 法规中对完整性测试的规定 FDA Guideline指南 (2003) Whatever filter or combination of filters is used, validation should include microbiological challenges to simulate worst-case production conditions…”对于由一个或多个滤器组成的过滤系统，对它的验证都应该包括在最差条件下进行的微生物挑战试验。 Regulations about integrity test法规中对完整性测试的规定 Revision of annex 1 to EC Guide to GMP for sterile medicinal products (1997) 欧盟对于无菌药品GMP指南的附件一(1997版) “The integrity of the sterilized filter should be verified before use and should b