原辅料如厂家规定有复验期可按厂家复验期走，如果没有。可以根据稳定性考察数据规定复验期。如有特殊储存要求物料可以适当缩短复验期。

厂家规定效期的前1个月或3个月或6个月，具体根据原料的使用周期自行确定即可，其主要目的是原料近效期 原料质量可能会出现不合格或超趋势，保证制剂的质量 因此需要近效期复验。

在识林全站检索“复验期”，可以查询到：

【FDA指南】

ANDA申报中对复验期信息的要求
What drug substance stability studies support the retest or expiration date and storage conditions for the drug substance?Can this question be answered by reference to a DMF?
Answer：The ANDA QOS should always include the retest or expiration date. The retest date or expiration is required to be present in the labeling of the drug substance container and to be present on all COAs. Drug substance stability data that supports the retest or expiration date should be included by reference to the DMF. SeeFDA QbR Frequently Asked Questions^[6]

^{从文中体现出的信息（The retest date or expiration is required to be present in the labeling of the drug substance container and to be present on all COAs.），复验期应从厂家放行检验开始计算。}