实施ICH Q3D的实用建议

julia朱玉姣

The "Industry Coalition" givespractical advice for the control of elemental impurities in active substancesand excipients

“行业同盟”提出活性物质和辅料中元素杂质控制的实用建议

The requirements of the "Guideline for Elemental Impurities ICH Q3D" publishedin December of last year mean a considerable expense for the affectedpharmaceutical companies and drug manufacturers in terms of laboratory andpersonnel upgrading (see also our news about "ICH Q3D - Elemental Impurities" of 07 January 2015).In addition, the deadlines for the implementation of this guideline are quitetight. (June 2016 for newly approved drugs and December 2017 for alreadyapproved drugs, see our news "CHMP adopts ICH Q3D Guideline as "Scientific Guideline"of 21 January 2015).

去年12月公布的“ICH Q3D元素杂质指南”中的要求意味着受影响的制药公司和药品生产商化验室有一笔可观的花费支出，并且要对人员升级（参见我们2015年1月7日的新闻“ICH Q3D元素杂质”）。另外，这个指南的实施日期实在是很紧。（新批准的药品要在2016年6月实施，已批准的药品要在2017年12月实施，参见我们2015年1月21日新闻“CHMP采纳ICH Q3D指南作为“科学指南”。）

Inthe March issue of "Pharmaceutical Technology Europe", an article ofthe "Industry Coalition" has been published with the title "Implementation of ICH Q3D Elemental Impurities Guideline:Challenges and Opportunities", which is intended to support theefffected companies with a number of pragmatic pieces of advice in theimplementation of these requirements.

在3月发行的“欧洲制药技术”中，有一篇“行业同盟”发布的题为“ICH Q3D元素杂质指南实施：挑战和机遇”的文章，其意在支持受影响的公司，提供许多实用建议来实施这些要求。

The"Industry Coalition" (exact name: "Coalition for RationalImplementation of Elemental Impurities Requirements") is a consortium ofeconomic/industrial associations (members include IPEC Europe, IPEC Americas,The Generic Pharmaceutical Association GPhA, etc.) and has been in existencesince 2011. The aim of the coalition is to provide information regardingelemental impurities. To this end, the Coalition has developed a standardisedprocedure (standardised information request) according to whichspecific information can be requested through the use of a form. Moreinformation about the "Industry Coalition", their goals and projectscan be found in a Position Paper which appeared in "PharmaceuticalTechnology Europe" in November 2012.

“行业同盟”（确切的名称为“元素杂质要求理性实施同盟”）是一个经济/行业协会组织（成员包括IPEC欧洲，IPEC美国，仿制药物协会GPhA等），自2011年就存在了。同盟的目标是提供关于元素杂质的信息。在结尾，同盟开发出了一种标准化的程序（标准化程序申请），根据该程序可以通过使用表格来申报获得特定的信息。关于“行业同盟”的更多信息，可以在上述链接“立场文件”中找到其目标和项目，它出现在2012年11月的“欧洲制药技术”中。

TheGuideline ICH Q3D calls upon drug manufacturer to conduct a risk assessment aspart of a strategy for the control of element impurities, but withoutspecifying which aspects need to be considered in such an assessment. Here, thearticle of the "Industry Coalition" provides helpful hints; itis described how, for example, production equipment (various types of steel),processing aids (activated carbon, silica gel, etc.), inorganic reagents, solvents,packaging materials and closure systems are to be included in the riskassessment. A detailed section is dedicated to the subject of excipients,regarding which the assessment of risks is often particularly difficult interms of element impurities, due to the unclear origin or the complexcomposition of the excipients.

ICH Q3D指南要求药品生产商实施风险评估，作为控制元素杂质的策略的一部分，但并没有说明在该评估中需要考虑哪些方面。这里，“行业同盟”的文章中提供了有用的提示，它描述了，例如，在风险评估中如何包括生产设备（不同类型的钢类）、工艺助剂（活性炭、硅胶等）、无机试剂、溶剂、包装和密闭系统。有一个详细的部分专门是关于辅料的，说明了元素杂质风险评估中哪些方面特别困难，因为辅料会有一些未知来源或复杂组成。

Theapproaches described by the "Coalition" may be useful for manycompanies in their efforts to meet the requirements of the Guideline ICH Q3D.In this context, the document which has recently been published by theEMA  entitled "Elemental impurities in marketed products. Recommendations forimplementation" should also be considered.

“同盟”中描述的方法可能对许多公司都有帮助，帮助他们符合ICH Q3D指南的要求。在此，还应考虑EMA最近公布的题为“已上市药品中的元素杂质：实施建议”的文件。

毒手药王邓智先

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