留样样品所用包装材料必须与上市包装一致？

第一问：
Question：Why does ICH Q7 permit the use of a packaging system for reserve/retention samples that is ‘more protective than the marketed packaging system’ [ICH Q7, Section11.72]?
Answer：Unlike stability samples, the purpose of the reserve/retention sample is not to represent the quality of the batch in the market place but to allow future evaluation of the quality of the original API batch (e.g., in evaluation of potential counterfeits, etc.). Therefore,reserve/retention samples may be stored in packaging (and conditions) that better preserve the original state of the API.
问：为什么 ICH Q7允许对留样使用“比上市包装系统更具有保护性”的包装【ICH Q7第11.72部分】？
答：与稳定性样品不同，留样的目的不是为了代表上市批的质量，而是为了将来对原始的API批质量进行评估（例如，评估可能的假药等）。 因此，留样可以保存在更能保存原料药原始状态的包装（和条件）中。
注：本问答摘自ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Questions and Answers（2015-06-10）。
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必须一致