“审核活性物质供应链的可追溯性”是指什么？

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                                         “审核活性物质供应链的可追溯性”是指什么？

在EU的GMP章节1.10中有这样一句话：
"review of starting materials including packaging materials used in the product, especially those from new sources and in particular the review of supply chain traceability of active substances"
翻译成中文是：要审核用于产品的其实物料包括包装材料，特别是那些从新来源处得到的，而且特别要审核活性物质供应链的可追踪性。
这个条款怎么理解呢？在实际操作中，生产厂往往是仅仅声明某个API是哪里生产的，也许还会提供一些供应商初次审核和定期维护的信息。这些内容不足以满足“活性物质供应链可追踪性的要求”。
举一个例子，A国家工厂生产了原料药，到B国家分装，运到C国家分销中心，由C国家销往全球。
如果在供应链信息中只体现其中一个地点，那就是不合适的，这不能满足整个供应链的可追踪性。相信各类标签、票据也会有不一致的信息。
使用者审核资料中应该涵盖每一个涉及到的点。
而且，这条供应链是会发生变化的，所以应该要求供货方及时提供变化信息，另外使用方也应该定期主动确认之类信息的变化。
MHRA官方的博客给予相关的解读，原文如下：


http://www.gmp-compliance.org/gmp-news/pqr-a-common-misunderstanding-when-it-comes-to-starting-materials
In Chapter 1.10 of the EU-GMP Guidelines the requirements for the Product Quality Review are described, also demanding a "review of starting materials including packaging materials used in the product, especially those from new sources and in particular the review of supply chain traceability of active substances" (1.10 i)
But what does this exactly mean? Does a manufacturer only have to re-state who manufactures the API because always the same company is and was used? "No" is the answer according to a blog published by the U.K. Medicines and Healthcare Products Regulatory Agency MHRA. Ewan Norton, a GMDP inspector of MHRA's inspectorate, criticises that chapter 1.10i is often "misinterpreted by companies as simply being a requirement to state the manufacturer and supplier of the API, but actually the requirement is to fully map all the parties involved in the supply chain and periodically re-assess this for accuracy.  Chapter 5 (5.29) provides more detail on this and makes it clear that the Active Substance supply chain traceability starts at the 'active substance starting materials' i.e. the Registered Starting Materials for the API manufacturing process.

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