EMA问答：能否将相同包装的多个批次作为一个单独的“超级批次”？

恨我不成钢

EMA（欧盟药监局）近日发布新的GMP问答：能否将包装（内包或外包）相同产品（例如片剂、胶囊、含片）的多个批次作为单独的一个批次从而变成一个“超级批次”？

Is it acceptable to pack (primary and/or secondary packaging) multiple batches of the same product (e.g. tablets, capsules, lozenges) in order to obtain a single batch as a "super batch"? H+V July 2018

问：能否将包装（内包或外包）相同产品（例如片剂、胶囊、含片）的多个批次作为单独的一个批次从而变成一个“超级批次”？

Normally, such an approach should be avoided as each batch is made from the same initial quantity of material and should remain as an individual batch of finished medicinal product bearing a unique batch number. Therefore, any other approach should be thoroughly justified by applying the principles of Quality Risk Management (QRM) taking into account at least the following criteria:

答：通常情况下，应该避免这种方法，因为每个批次由相同的初始数量的物料制成，应该保留为具有唯一批号的单批成品药品。因此，任何其他方法都应通过应用质量风险管理（QRM）原则进行彻底证明，并至少考虑以下标准：

• length of time the equipment has been in use;
  设备的使用时长;
• pharmaceutical form of the drug product that cannot be homogenised (tablet, capsules, etc);
  药品的药物形式，不能均质化（片剂，胶囊等）;
• expiry date of the drug products;
  药品的有效期;
• ongoing stability study design and results;
  持续稳定性试验设计和结果;
• reference samples plan for each batch;
  每批对照样品的留取计划;
• criticality of the drug product and the risk of shortage that may arise from any quality issue;
  任何质量问题可能引起的药品的危险性和短缺风险;
• prior approval of the MAH.
  在批准MAH之前。
  
  

Irrespective of the outcome of the QRM, such an approach can only be accepted if each individual batch of the combined "super batch" undergoes all the in-process control and finished drug product testing as specified in the marketing authorisation dossier.

无论QRM的结果如何，只有当合并的“超级批次”的每一个单独批次经历了注册文件中规定的所有IPC和成品检验时，才能接受这种方法。

In the event of a recall, the entire “super batch” should be recalled.

一旦召回，应该召回整个“超级批次”。

恨我不成钢

我感觉这直接不符合“批”的定义。其他的都是废话，你们觉得呢 ？

预知子

超级批次有必要吗？一旦出现问题全部都要召回

leasua

纯属自己给自己增添麻烦