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影子
第11楼2012/10/30
这个是针对原料药的，来自ICH Q7：
11.7 留样 Reserve/Retention Samples
11.7.0 留样的包装和储存是为了今后可能会对原料药批号的质量进行评价，而不是以将来的稳定性测试为目的的。
The packaging and holding of reserve samples is for the purpose of potential future evaluation of the quality of batches of API and not for future stability testing purposes.
11.7.1 适当标识的每一批原料药的留样应当保留到有制造商规定的该批号的有效期过后一年，或该批产品分发后三年，以长的为准。对于有复测期的原料药，相似的留样应当保留到制造商全部分发完该批号后三年。
Appropriately identified reserve samples of each API batch should be retained for 1 year after the expiry date of the batch assigned by the manufacturer, or for 3 years after distribution of the batch, whichever is longer. For APIs with retest dates, similar reserve samples should be retained for 3 years after the batch is completely distributed by the manufacturer.秋醉虞阳(wangjianhua1102) 发表:保证质量可追溯，为同类产品生产提供参考和相关审核要求？留样期限是保质期+1年？
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秋醉虞阳
第13楼2012/10/30
原本是药姐！其他产品也差不多吧。我记得食品行业也一样的。
影子(hyheying) 发表:这个是针对原料药的，来自ICH Q7：
11.7 留样 Reserve/Retention Samples
11.7.0 留样的包装和储存是为了今后可能会对原料药批号的质量进行评价，而不是以将来的稳定性测试为目的的。
The packaging and holding of reserve samples is for the purpose of potential future evaluation of the quality of batches of API and not for future stability testing purposes.
11.7.1 适当标识的每一批原料药的留样应当保留到有制造商规定的该批号的有效期过后一年，或该批产品分发后三年，以长的为准。对于有复测期的原料药，相似的留样应当保留到制造商全部分发完该批号后三年。
Appropriately identified reserve samples of each API batch should be retained for 1 year after the expiry date of the batch assigned by the manufacturer, or for 3 years after distribution of the batch, whichever is longer. For APIs with retest dates, similar reserve samples should be retained for 3 years after the batch is completely distributed by the manufacturer.
