关于过热灭菌的最终灭菌大容量注射剂，分多次灭菌柜灭菌，请问大家的取样的方式是什么？？？还有分次灭菌每个灭菌柜取样的取样是单独进行无菌检测，还是合并进行无菌 检测呢？？？ 2. What are the sampling requirements for sterility testing when a finished product batch of a terminally sterilised medicinal product is made up of more than one steriliser load? H+V October 2008The sampling plan for sterility testing should take account of the definition of a batch as stated in the glossary of the GMP guideline together with the recommendations of annex 1 section 93 (section 127 in the February 2008 revision). Each steriliser load is considered to be an independent sub-batch. Consequently, one sterility test should be performed per sub-batch. The number of samples per steriliser load should conform to European Pharmacopoeia requirements, section 2.6.1.3. Can there be any exceptions to this rule?For large-volume parenterals where the sterilisation cycle has been qualified with an overkill level, an alternative sampling plan in accordance with a specific internal procedure agreed with the supervisory authority can be accepted (unless already specified in the marketing authorisation).
This procedure should state the need to sample from each steriliser load including the coolest location identified during the steriliser qualification. The number of samples per load should be defined based on a risk-based approach and the overall number of samples per batch should conform to European Pharmacopoeia requirements, section 2.6.1.3. An alternative option, which would require a variation to relevant existing marketing authorisations, would be to introduce a system of parametric release, thereby avoiding the need to carry out the sterility test.
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 京ICP证150354号 互联网药品信息服务证书编号: (京)-非经营性-2024-0033
发表于 2016-6-28 21:35:51
置顶卡
变色卡
