欧洲药典中的ICH Q3D实施：修订了2份通论

julia朱玉姣

GMP News
06/04/2016

ICHQ3D implemented in the European Pharmacopoeia: Revision of Two GeneralMonographs with Regard to Elemental Impurities

欧洲药典中的ICHQ3D实施：修订了2份通论

In a press release dated 30 November 2015, the EDQM announcedthe revision of two general pharmacopoeial monographs: "Substances forpharmaceutical use" (2034) and "Pharmaceutical preparations"(2619). The decision was taken during the 153rd session of the EuropeanPharmacopoeia Commission; the Commission follows its strategy for implementingtheICH Guideline Q3D "Guideline for ElementalImpurities" in the European Pharmacopoeia. A section "ElementalImpurities" has been added to both monographs which emphasizes that theprovisions laid down in General Chapter 5.20 of the Pharmacopoeia (identical inwording with ICH Q3D) apply to the limits of metallic impurities and to theircontrol. For pharmaceutical preparations and substancesfor pharmaceutical use outside the scope of Chapter 5.20 (e.g. unlicensedpatient-specific preparations, herbal products, radiopharmaceuticals, etc.),the manufacturer is obliged to perform a risk assessment with regard to thelimits of those impurities and - if necessary - to use validated analyticalprocedures for their determination. The principles to be applied forsuch a risk assessment arise from a press release from the EDQM dated 7 August 2015: it isexpected that the provisions defined on the Guidelines ICH Q3D or ICHQ9 are followed. Lastly, according to this press release, the controlstrategy of elemental impurities as well as the substantial demonstration ofsuitability of the analytical methods used in the marketing authorisationdossier remains in the responsibility of the manufacturer.

在2015年11月30日的媒体发布上，EDQM宣布将修订2份药典通论“药用物质”（2034）和“药物制剂”（2619）。这个决定是在第153次欧洲药典委员会会议上做出的，委员会遵循了欧洲药典中实施ICH Q3D元素杂质指南的策略。元素杂质的一个部分已经被加入到两个通论中，其中强调了通则5.20（与ICHQ3D用词一样）中制订的条款，适用于金属杂质的限度及其控制。对于不在5.20范围内的药物制剂和药用物质（例如，未授权的患者特定制剂、草药制品、放射性药品德平），生产商有义务针对这些杂质限度进行风险评估，必要时，采用经过验证的分析方法测定。适用于此风险评估的原则是在2015年8月7日的EDQM媒体发布上给出的：期望遵循ICH Q3D或ICH Q9指南中定义的条款。最后，根据此媒体发布的信息，元素杂质的控制策略和上市许可文件中所用的分析方法的适用性严谨证明也是生产商的职责。

Thedefinition of "Substances for pharmaceutical use" in the monograph2034 states: "Substances for pharmaceutical use are any organic orinorganic substances or excipients for the production of medicinal products forhuman or veterinary use. ... Substances for pharmaceutical use may be usedas such or as starting materials for subsequent formulation to preparemedicinal products. Depending on the formulation, certain substances may beused either as active substances or as excipients."

在通论2034中对“药用物质”的定义说：“药用物质是有机或无机物质，或辅料，它们用于人兽用药品的生产……药用物质可以直接使用，也可以用作后续配方的起始物料，来制备药品。根据制剂生产配方不同，特定的物质可以用作活性物质也可以用作辅料”。

The draftsof the two revised general monographs are accessible for free in the Journal"Pharmeuropa",Edition 28/2. You only need to register and log in with your password. Thecomment deadline for both monograph drafts ends on 30 June 2016.

两份修订后的通论可以在28/2版药典在线杂志上找到。征求意见截止日期为2016年6月30日。

迈克陈

学习，多谢楼主分享

孙艳红

给力

syhorchid

了解一下

北重楼

学习了解一下，太给力了

大毛小毛

  太给力了   谢谢

呼吸

涨智商了，多学习下英文