ECA新闻：减少起始物料取样和检测的机会

GMP News
09/11/2016

Opportunities for Reducing Sampling and Testing of Starting Materials

减少起始物料取样和检测的机会

Chapter 5 of the EC GMP Guide for the area of production was already updated last year. However, not everybody really knows that it contains concrete information about the conditions when testing and sampling of APIs and excipients can be reduced. Particularly sections 5.35 and 5.36 include requirements and thus show possibilities for a reduction.

EU GMP指南第5章生产在去年进行了更新。但是，并不是所有人都真的知道其中有一些具体的信息，是讲原料药和辅料的取样和检测可以减少的条件。尤其是第5.35和5.36包括有相关要求，而其中显示出减少的可能性。

Basically, the manufacturers of finished products are responsible for every testing of starting materials as described in the marketing authorisation dossier. Yet, part of or complete test results from the approved starting material manufacturer can be used, but at least their identity has to be tested - as described in the in the marketing authorisation dossier.

基本来说，制剂生产商负责按上市许可申报文件中所述对对起始物料进行检测。但是，可以使用经过批准的起始物料生产商的一部分或全部检测结果，但至少必须按上市许可申报资料中所述做鉴别项。

If one chooses to outsource the testing activity to the supplier, this has to be justified and documented. Moreover, a few additional measures have to be fulfilled, like:

如果制剂商选择外包检测活动，则必须进行论述和记录。另外，还必须满足一些其它的措施要求，如：

• Particular attention should be paid to the distribution controls (transport, wholesaling, storage, delivery) to ensure that ultimately the test results are still applicable to the delivered material.
• 要特别注意销售控制（运输、批发、存贮、发货），以确保检验结果最后还是适用于所发送的物料。
• Performance of risk-based audits at the sites executing the testing and sampling of starting materials to verify the GMP compliance and to ensure that the specifications and testing methods are used as described in the marketing authorisation dossier.
• 对起始物料检测和取样场所实施基于风险的审计，核实GMP符合性，确认所用的质量标准和检测方法与上市许可资料所述一致。
• The certificate of analysis of the manufacturer/supplier of the starting material should be signed by a designated person with appropriate qualifications and experience. The signature confirms the compliance with the agreed product specification.
• 起始物料的生产商/供应商检验报告应有负责人签名，其应具备适当的资质和经验。签字确认符合协议的产品质量标准。
• The medicinal product manufacturer should have adequate experience in dealing with the starting material manufacturer - including assessment of batches previously received and the history of compliance before reducing own, internal testing.
• 药品生产商应具备足够的处理起始物料生产商的经验----包括之前收到的批评估，以及在减少自己内部的检测之前的符合性历史。
• At appropriate intervals, the medicinal product manufacturer or another approved contract laboratory has to carry out a full analysis to compare the test results with the results of the certificate of analysis of the material manufacturer or supplier, and thus to check their reliability. In case of discrepancy, an investigation has to be performed and appropriate measures taken. The certificates of analysis cannot be accepted until those measures are completed.
• 按照适当的间隔，制剂生产商或经过批准的合同化验室必须进行全检，将结果与原料生产商或供应商的分析报告结果进行比较，检查其可靠性。如果有差异，则必须进行调查，采取适当的措施。在完成这些措施之前不能接受分析报告。
  

You can access the complete Chapter 5 "Production" of the EU GMP Guide here.

在上述网址可以找到完整的EU GMP指南第5章“生产”。

来源：

Julia

谢谢分享！！！！！