EU gmp ANNEX 19 留样
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There may be exceptional circumstances where this requirement can be met without retention of duplicate samples e.g. where small amounts of a batch are packaged for different markets or in the production of very expensive medicinal products.

“EU GMP Annex 19 Reference and Retention Samples”

这段话中duplicate如何理解？

2024-03-18 17:15 匿名     
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奥星出版的欧盟GMP法规汇编-2018是如下翻译的


2024-03-18 18:57 亦心     
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沐清风 2024-03-19 10:45

认同这个翻译，这样和后边的不同包装，最少保留一支样品对应起来，

Where a batch is packaged in two, or more, distinct packaging operations, at least one retention sample should be taken from each individual packaging operation. 

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个人理解，结合上下文，duplicate应该指的是reference sample和retention sample同时保留，即同样的样品出于不同的目的保留了双份。

但是特殊情况下，如果一些药品批量小或者非常昂贵，如果已经保留了前一个目的的样品，后者就可以豁免。

2024-03-18 19:42 YoyoXU     
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Annex 19 留样（retained sample）包括2类，reference sample (a sample of a batch of starting material, packaging material or finished product) 和 retention sample（a sample of a fully packaged unit from a batch of finished product）。

在批量小或药品贵重的情况下，可以没有重复的retention sample，只保留reference sample即可（也就是reference sample 已经包括了retention sample）。

2024-03-18 20:09 Sumei     
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沐清风 2024-03-19 10:40

按照这个解读，只保留reference sample，也需要两倍的样品量，这样和后边的这句话就没有衔接了

For finished products, in many instances the reference and retention samples will be presented identically, i.e. as fully packaged units. In such circumstances, reference and retention samples may be regarded as interchangeable.

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