稳定性包装问题

皮皮风云

在FDA关于稳定性研究指南的Guidence文件看到对于药品包装的要求（如下）：
一般情况不需要采用不同批次的包装材料，除非包装材料可能会对药品性能和/或运输产生影响。请教各位蒲友，哪些包装材料属于此类呐？不解~~
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?
A4: It is not necessary to use different lots of APIs or packaging material, except in cases where the packaging material could affect drug product performance and/or delivery. A minimum of two lots of the drug substance should be used to prepare the three primary batches of drug product.

pfz2867

你这翻译的不对吧，应该是API可以不用市售包装

915_雨

重点不同：是考察药品的稳定性，不是考察包材相容性，所以不必追求不同批的包材。

飞凌大圣

举个例子吧，不一定很恰当：
原来是纸盒包装的，现在你要换成不锈钢盒包装，肯定是有差异的