起始材料的每个容器必须取样做鉴别？

罗伊鲱

23.05.2018

Must eachcontainer of a starting material be sampled for identification?

起始材料的每个容器必须取样做鉴别？

The Canadian health authority haslisted the question "Does everyindividual container of a raw material need to be sampled for identification(ID) purposes" in their section "Good ManufacturingPractices (GMP) Questions and Answers" and answered it as follows:
加拿大卫生部门在其“生产质量管理规范（GMP）问答”一节中列出了“是否原材料的每个容器都需要抽样用于鉴别（ID）”的问题，并回答如下：
For human medicines, eachcontainer of a batch ofstarting material mustbe tested for the identity of its content. Therefore, each container of eachstarting material, including excipientsand active pharmaceutical ingredients (APIs),must be opened and sampled. After that, two options are possible:
对于人用药物，一批起始物料的每个容器都必须检测内容物的身份。因此，每种起始材料（包括赋形剂和API）的每个容器都必须打开并取样。在此之后，可能有二种选择：
1. Each sample is tested foridentity by a discriminatory method (it is not necessary to perform all IDtests in compliance with the specifications, e.g. as per USP, but the ID testmust be specific).
1. 通过有辨识力的方法对每份样品进行鉴别测试（不需要按照标准执行所有ID测试，例如根据USP，但ID测试必须是特异性的）。
2. If a starting material istested for potency, the second option is to mix and merge individual samplesfrom each container into a composite sample. However, not more than tenindividual samples should be used in a compositesample. A specific ID test must be performed for each compositesample; a content determination is also to be executed.
2. 如果测试起始物料的效力，第二种选择是将每个容器的单独样品混合并合并成一个复合样品。但是，一个复合样品中不应使用超过10个单独样品。必须对每个复合样本进行特异的ID测试；含量测定也要被执行。
At the end of the question, apractical example on how the sampling of 72 containers of the same batch ofstarting material should be performed is included.
在问题的最后，还包括了一个关于如何对同一批起始物料的72个容器进行取样的实例。
The complete question as well asits answer can be found in the Health Canada's Good Manufacturing Practices (GMP) Questions and Answersunder Raw Material Testing - C.02.009 & C.02.010.
完整的问题及其答案可以在加拿大卫生部的GMP问答中原材料测试－C.02.009和C.02.010下找到。
Strictly speaking, theserequirements only apply for the Canadian market. Nevertheless, theseregulations may be viewed as state of the art recommendations worldwide.
严格地说，这些要求只适用于加拿大市场。尽管如此，这些规定可以被视为全球技术水平的建议。

原文：https://www.gmp-compliance.org/g ... -for-identification

我要吃苹果

tga法规要求 出口tga必须遵守

快活王

这样的话，后期是不是只有使用拉曼光谱才会方便了。现在FDA应该是允许对供应商审计确认后不用对每个容器进行鉴别测试。

紫气东来2018

投料前每件物料做近红外图谱鉴别，国际上比较认可。

beiwei5du

按照内容来说，每袋取样是必须，至于是否做每袋鉴别则不是强行的（比如pooled sample)

XQW

输液原料葡萄糖每次几百甚至上千件，能每件取吗？

syhorchid

谢谢分享

xqliu

谢谢提供分享

lhd000000

谢谢分享