减少起始物料取样和检验的机会

北重楼

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，其中讲了可以减少原料和辅料的取样和检验的条件。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起始物料进行检验。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验结果，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验活动，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.对起始物料检验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验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----包括之前收到的批的评估，以及在减少自己内部的检验之前的符合性历史。
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。

EU GMP Part 1  Chapter 5: ProductionEU GMP指南第1部分第5章：生产
5.35   Manufacturers of finished products are responsible for any testing of starting materials[3] as described in the marketing authorisation dossier. They can utilise partial or full test results from the approved starting material manufacturer but must, as a minimum, perform identification testing[4] of each batch themselves according to annex 8.
制剂生产商对原辅料按上市许可申报文件中的描述所进行的全部检验项目承担责任。生产商部分或全部使用经过批准的原辅料生产商的检验结果，但必须至少根据附录8对每个批次进行鉴别检验。 5.36 The rationale for the outsourcing of this testing should be justified and documented and the following requirements should be fulfilled:
将上述检验外包应进行合理论证并记录，且应满足以下要求： i.        Special attention should be paid to the distribution controls (transport, wholesaling, storage and delivery) in order to maintain the quality characteristics of the starting materials and to ensure that test results remain applicable to the delivered material;

对于销售记录应特别注意（运输、批发、存贮和发运），以维持原辅料的质量特性，并保证所收到的物料质量仍与原始检验结果相符合。

ii.      The medicinal product manufacturer should perform audits, either itself or via third parties, at appropriate intervals based on risk at the site(s) carrying out the testing (including sampling) of the starting materials in order to assure compliance with Good Manufacturing Practice and with the specifications and testing methods described in the marketing authorisation dossier;
制剂生产商应亲自或委托第三方进行审计，审计时间间隔应基于对测试原辅料（包括取样）的场所的风险来确定，以保证其符合GMP，并按上市许可申报文件中描述的质量标准和检验方法进行检验。

iii.    The certificate of analysis provided by the starting material manufacturer/supplier should be signed by a designated person with appropriate qualifications and experience. The signature assures that each batch has been checked for compliance with the agreed product specification unless this assurance is provided separately;
原辅料生产商/供应商提供的分析报告应由指定的具备适当资质和经验的人员签字。签字表示保证每批均经过检查且符合共同同意的产品质量标准，否则应单独提供上述保证。

iv.     The medicinal product manufacturer should have appropriate experience in dealing with the starting material manufacturer (including experience via a supplier) including assessment of batches previously received and the history of compliance before reducing in-house testing. Any significant change in the manufacturing or testing processes should be considered;
制剂生产商应具备适当的与原辅料生产商打交道的经验（包括通过中间商采购的经验），包括对之前收到的批次的评估，在减少内控测试前对其历史符合性的评估。要考虑所有生产或检验程序的重大变更。 v.       The medicinal product manufacturer should also perform (or via a separately approved contract laboratory) a full analysis at appropriate intervals based on risk and compare the results with the material manufacturer or supplier’s certificate of analysis in order to check the reliability of the latter. Should this testing identify any discrepancy then an investigation should be performed and appropriate measures taken. The acceptance of certificates of analysis from the material manufacturer or supplier should be discontinued until these measures are completed.
制剂生产商还应（或通过一个单独批准的合同化验室）根据风险在一定时间间隔进行全检，并与原料生产商或中间商检验报告书上的结果进行比较，以检查后者的可靠性。如果该检验发现有不符合处，则应进行调查并采取适当的措施。在这些措施完成前，不应继续接受来自原料生产商或中间商的分析报告书。

转载自GMP办公室微信

zysx01234

有个卵用

beiwei5du

这个也是一种合理的可选择方式。比如某种检测项目，本身风险不大，同时检测频率不多，检测设备费用巨大（包括投资设备费用巨大），为什么不可以采取供应商评估的方式，在风险可接受的条件下，采纳供应商的检测结果以及周期性外包检测核实的方式呢？

2A2MXnrNlF

zysx01234 发表于 2016-11-10 08:39
有个卵用

井底蛙、别自为是。

jyc071000

感谢分享！