EU gmp reference sample与retention sample
其他

EU gmp annex19中关于 reference sample与retention sample的描述是否适用于原料药?我看里面主要是对成品制剂做出了规定,原料药应该不适用吧,只要保证有两倍全检量作为留样量应该就足够了吧。

2024-03-28 09:48 用户pidx     
1个回答

Reference sample:  a sample of a batch of   starting material ,   packaging material  or  finished product  which is  stored  for the purpose of being analysed should the need arise during the  shelf life  of the batch concerned. Where stability permits, reference samples from critical intermediate stages (e.g. those requiring analytical testing and release) or  intermediates , that are transported outside of the manufacturer's control, should be kept.

Retention sample: a sample of a fully packaged unit from a batch of finished product. It is stored for identification purposes. For example, presentation, packaginglabelling, patient information leaflet, batch numberexpiry date should the need arise during the shelf life of the batch concerned. 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.

这里边提到的starting material是指制剂的起始物料就是API的意思,而retention sample只适用于制剂。

2024-03-28 17:16 匿名     
史地小学生 2024-03-28 18:48

这里的 starting material 是指制剂的起始物料,也就是原辅料,除了API,还有辅料。

Starting material :Any substance used in the production of a medicinal product, but excluding  packaging materials .

——EU GMP 第一部分 - 药品的基本要求