FDA原料药和制剂稳定性试验问答.pdf

201308 FDA 指南：ANDA：原料药和制剂稳定性试验问答（中英文） C. Drug Product Manufacturing and Packaging 药品生产和包装 Q1: Can the split bulk solution filled into different fill volumes be considered different batches? 将散装溶液装入不同分装体积应作为不同批号吗？ A1: No. Split filling one batch of bulk solution into different fill volume sizes does not constitute discrete batches. 不。分装一个批号散装溶液至不同分装体积不构成分批。 Q2: Can you clarify the packaging recommendations for the submission batches for blow-fill-seal containers? 可否说明一下对吹瓶/灌装/封口的包装形式申报批有什么包装方面的建议？ A2: Blow-fill-seal containers are not an exception from regular packaging and are usually packaged inside a secondary container or a carton. The secondary packaging should be included in all three batches. ICH Q1A(R2) addresses secondary packaging usefulness (see section II, B, 4, Drug Product Container Closure System (2.2.4)). 吹瓶/灌装/封口的包装形式仍是常规包装的一种，通常还会有外包装或纸箱包装。三个批次均应进行外包 装。ICH Q1A(R2)里说明了外包装是有用的。（参见第II 部分，B，4，药品包装（2.2.4）） Q3: Should all three batches be stored in final proposed packaging? 所有三个批次均应以完整的包装形式存贮吗？ A3: Yes. You should package all three batches in the container closure system proposed for marketing. Q1A(R2) addresses this question (see section II, B, 4, Drug Product Container Closure System (2.2.4)). 是的。需要将三批产品以上市申请的包装形式进行包装。Q1A(R2)中说明了该问题（参见第II 部分，B， 4，药品包装（2.2.4））。 Q4: What is the Agency’s position on using different lots of APIs and/or packaging materials? How many API lots should be used in the manufacture of finished product lots used to support the ANDA? 法规当局对于采用不同批次原料药和/或包装材料是什么态度？在药品生产中可以使用多少批次原料药来 支持ANDA？ A4: A minimum of two lots of the drug substance[ 1] should be used to prepare the three primary batches of drug product. It is not necessary to use different lots 1 of packaging material, except in cases where the packaging material could affect