关于最终灭菌的无菌制剂的批次划分问题

beiwei5du

3) Definitions of Batch / Lot: A Master Formula is required for each batch and batch size. A “batch” or “lot” as definedin the WHO GMP guideline (TRS 908 Annex 4) is”
“batch (or lot)A defined quantity of starting material, packaging material, or productprocessed in a single process or series of processes so that it isexpected to be homogeneous. It may sometimes be necessary todivide a batch into a number of sub-batches, which are later broughttogether to form a final homogeneous batch. In the case of terminalsterilization, the batch size is determined by the capacity of the autoclave.In continuous manufacture, the batch must correspond to a definedfraction of the production, characterized by its intended homogeneity.The batch size can be defined either as a fixed quantity or as the amountproduced in a fixed time interval”.
In general, the term “batch” more often refers to intermediates or final formulated bulkswhich are in one or a few large containers, while “lot” usually refers to the final productin the final container. They are, however, interchangeable as indicated in WHO’s GMPguideline glossary.  


第六十条  除另有规定外，无菌药品批次划分的原则：
（一）大（小）容量注射剂以同一配液罐最终一次配制的药液所生产的均质产品为一批；同一批产品如用不同的灭菌设备或同一灭菌设备分次灭菌的，应当可以追溯；
（二）粉针剂以一批无菌原料药在同一连续生产周期内生产的均  质产品为一批；
（三）冻干产品以同一批配制的药液使用同一台冻干设备在同一生产周期内生产的均质产品为一批；
（四）眼用制剂、软膏剂、乳剂和混悬剂等以同一配制罐最终一次配制所生产的均质产品为一批。


关于“In the case of terminal sterilization, the batch size is determined by the capacity of the autoclave”如何理解？？？

scslk0045

和中国GMP一样，依据灭菌柜灭菌能力（经过验证）来确定批量。

beiwei5du

scslk0045 发表于 2016-11-5 06:54
和中国GMP一样，依据灭菌柜灭菌能力（经过验证）来确定批量。

中国的：
大（小）容量注射剂以同一配液罐最终一次配制的药液所生产的均质产品为一批；同一批产品如用不同的灭菌设备或同一灭菌设备分次灭菌的，应当可以追溯；
而冻干是按照：
冻干产品以同一批配制的药液使用同一台冻干设备在同一生产周期内生产的均质产品为一批； 我个人也觉得结合配制和灭菌一起考虑，使用灭菌柜灭菌能力为批量！