20151022 ECA新闻：原料药的供应链要记录到什么程度？EMA给出了回答

20151022 ECA新闻：原料药的供应链要记录到什么程度？EMA给出了回答  

GMP News
22/10/2015

To what extent does the supply chain for APIs have to be documented? The EMA provides the answer

原料药的供应链要记录到什么程度？EMA给出了回答

Pharmaceutical companies facing an official GMP inspection should be prepared that the Inspector will ask to see a complete documentation of the supply chain of the active ingredients (including appropriate risk assessments) - going back to the starting materials which were used for the synthesis of the APIs. In an update of the Question & Answer collection to the GMP Guide Part 1: "Basic requirements for medicinal products: Chapter 5: qualification of suppliers" the EMA has recently clarified this. According to this, medicinal product manufacturers have to demonstrate that each active ingredient delivery comes from an approved supplier, which, in turn, has to make available the complete documentation of the supply chain for the starting materials. The medicinal product manufacturer has to verify the entire supply chain on a regular basis according to risk-based criteria.

药业公司现在正面临官方GMP检查，检查中检查员会要求查看原料药供应链的完整记录（包括适当的风险评估）--追溯回用于原料药合成的起始物料。在最近更新的GMP问答汇总第一部分“药品基本要求：第5章：供应商确认”中，EMA最近对此进行了澄清。据此，药品生产商必须证明每个原料药运输自一个经过批准的供应商，也就是说，必须有起始物料的供应链的完整文件记录。药品生产商必须根据基于风险的标准定期核实整个供应链。

Below, the wording of the statement of the EMA:

以下是EMA声明原文：

"The supply chain for each active substance must be established back to the manufacture of the active substance starting materials. This should be documented and must be kept current. The risks associated with this supply chain should be formally documented. Control of each incoming consignment of active substance should include verification that it has been received from the approved supplier and approved manufacturer. The entire supply chain should be verified for a supplied batch periodically to establish a documented trail for the batch back to the manufacturer(s) of the active substance starting materials. The frequency of this verification should be based on risk."

“必须建立每个活性物质的供应链，可以追溯至活性物质起始物料。这些必须进行记录，必须保持更新。与此供应链相关的风险应有正式文件记录。每次收到的活性物质货物的控制应包括核实它是来自批准的供应商和批准的生产商。应定期核实收到货物的整个供应链，以建立文件化途径，可以追溯回活性物质起始物料的生产商。此核实的频次应基于风险决定。”

转载自：http://zhuyujiao1972.blog.163.com/blog/static/98694727201592210950644/

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