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1、人用药所用辅料的GMP水平确定用正式风险评估指南Guideli nesof 19 March 2015on the formalised risk assessme nt for ascerta ining the appropriate goodmanu facturi ng practice for excipie nts of medici nal products for huma nuse(Text with EEA releva nee)(2015/C 95/02)In troduct ion概述These guideli nes are based on the fifth pa
2、ragraph of Article 47 of Directive 2001/83/EC (1).这些指南是基于指令 2001/83/EC(1)第47条款第5段落的。Accordi ng to the seco nd paragraph of Article 46(f) of Directive 2001/83/EC, the manu facturi ng authorisatio n holder is required to en sure that the excipie nts are suitable|for use in medici nal products by ascer
3、ta ining what the appropriate good manu facturi ng|practice (GMP) is. The appropriate GMP for excipie nts of medici nal products for huma n|use shall be ascerta ined on the basis of a formalised risk assessme nt in accorda nee with these guideli nes. The risk assessme nt shall take into acco unt req
4、uireme nts un der other appropriate quality systems as well as the source and intended use of the excipients and previous in sta nces of quality defects. The manu facturi ng authorisati on holder shall en sure that the appropriate GMP ascerta ined is applied. The manu facturi ng authorisati on holde
5、r shall docume nt the measures take n.根据指令2001/83/EC(1)第46(f)条款第2段，生产许可持有人应保证辅料适用于其在药品 中的用途，确认怎样的GMP是适当的。人药用辅料适当的GMP应根据这些指南，基于正式的风险评估进行确定。风险评估应考虑在其它适当质量体系下的要求，以及辅料来源和辅料用途，和之前的质量缺陷情况。生产许可持有人应保证所确定的适当的GMP是适用的。生产许可持有人应记录所采取的措施。The excipie nt risk assessme nt/risk man ageme nt procedure should be in cor
6、porated in the pharmaceutical quality system of the manu facturi ng authorisati on holder.辅料风险评估/风险管理程序应结合在生产许可持有人的药品质量体系中。Manu facturi ng authorisatio n holders should have the risk assessme nt/man ageme nt docume ntati on for appropriate GMP for excipie nts available on site for review by GMP in s
7、pectors. Con siderati on should be give n to shari ng releva nt in formati on from the risk assessme nt with the excipie nt manu facturer to facilitate con ti nu ous improveme nt.生产许可持有人应有针对辅料所用的适当的GMP要求的风险评估/管理文件记录，并能提供能GMP审核人员审核。应考虑与辅料生产商共享风险评估所产生的相关信息，以促进持 续改进。A risk assessment as set out in thes
8、e guidelines should be carried out for excipients for authorised medici nal products for huma n use by 21 March 2016.自2016年3月21日起，人用上市药品用的辅料应实施这些指南中要求的风险评估。CHAPTER 1 SCOPE第1章范围These guideli nes apply to the risk assessme nt for ascerta ining the appropriate GMP for excipie nts for medici nal product
9、s for huma n use. Accord ing to Article 1(3b) of Directive 2001/83/EC, an excipie nt is any con stitue nt of a medici nal product other tha n the active substa nee and the packagi ng material.这些指南适用于风险评估，来评价应用适当的GMP于人用药所用辅料管理。根据指令2001/83/EC的第1(3b)条款，一种辅料是药品中除活性物质和包装材料外任意的组成部分。These guideli nes do no
10、t cover substa nces added to stabilise active substa nces that cannot exist on their own.这些指南不涵盖添加入药品中用于那些不能单独存在，而需要在活性物质中添加稳定剂来使活性物质稳定的成份。CHAPTER 2 DETERMINATION OF APPROPRIATE GMP BASED ON TYPE AND USEOF EXCIPIENT第2章基于辅料类型和用途的适当的GMP决策In EudraLex Volume 4, Guideli nes for Good Manu facturi ng Pract
11、ice, Medici nal Products for Human and Veterinary Use, Part III: GMP related documents, ICH guideline Q9 on Quality Risk Man ageme nt (ICH Q9), prin ciples and examples of tools for quality risk|man ageme nt that can be applied to differe nt aspects of pharmaceutical quality, in clud ing excipie nts
12、, can be found. |在欧盟药品法卷4，人用和兽用药品 GMP指南，第3部分，GMP相关文件，ICH指南Q9 质量风险管理中，可以找到能应用于药品质量，包括辅料，不同方面的质量风险管理的原则 和工具实例。These quality risk management principles should be used to assess the risks presented to the quality, safety and fun cti on of each excipie nt and to classify the excipie nt in questi on, e.g.
13、 as low risk, medium risk or high risk. Quality risk management tools such as those listed in EudraLex Volume 4, Part III, ICH Q9 (e.g. hazard analysis and critical control points HACCP) should be used for this purpose.这些质量风险管理原则应用于评估每种辅料所呈现的质量、安全和功能方面的风险For each excipie nt from each manu facturer u
14、sed, the manu facturi ng authorisati on holder should ide ntify the risks prese nted to the quality, safety and function of each excipie nt|from its source be that ani mal, min eral, vegetable, syn thetic, etc. through to its in corporati on in the fini shed pharmaceutical dose form. Areas for con s
15、iderati on should in clude, but are not limited to:来自于每个生产商的每种辅料，生产许可持有人应从其来源-动物、矿物、植物、合成等-识别每种辅料的质量、安全和功能风险，通过其结合于制剂成品的方式。要考虑的内容应包括但不仅限于：tran smissible spon giform en cephalopathy;TSE风险potential for viral contamination;病毒污染的可能性pote ntial for microbiological or en dotox in/pyroge n con tam in ati on
16、;微生物或内毒素/热原污染可能性potential, in general, for any impurity originating from the raw materials, e.g.aflatox ins or pesticides, or gen erated as part of the process and carried over, e.g. residual solve nts and catalysts;原料中产生的任何杂质存在的可能性，例如，黄曲霉素或杀虫剂，或作为工艺一部分产生和带入的杂质，例如，残留溶剂和催化剂sterility assuranee for excipients claimed to be sterile;声明无菌的辅料的无菌保证pote nti
