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1、20150319 欧盟 人用药活性物质 GDP原则(2015/C 95/01) Guidelinesof 19 March 2015on principles of Good Distribution Practice of active substances for medicinal products for human use人用药活性物质 GDP 原则指南(Text with EEA relevance)(2015/C 95/01)Introduction 概述These guidelines are based on the fourth paragraph of Article 4
2、7 of Directive 2001/83/EC (1).这些指南是基于指令 2001/83/EC(1)第 47 条的第 4 段。They follow the same principles that underlie the guidelines of EudraLex Volume 4, Part II, Chapter 17, with regard to the distribution of active substances and the Guidelines of 5 November 2013 on Good Distribution Practice of medici
3、nal products for human use (2).他们遵守在欧盟药品法第 4 卷第 2 部分第 17 章指南中规定的关于原料药销售，和 2013 年11 月 5 日人用药 GDP 规范相同的原则。These guidelines provide stand-alone guidance on Good Distribution Practice (GDP) for importers and distributors of active substances for medicinal products for human use. They complement the rule
4、s on distribution set out in the guidelines of EudraLex Volume 4, Part II, and apply also to distributors of active substances manufactured by themselves.这些指南为人用药所用的原料药的分销商和进口商提供了单独的 GDP 指南。它们补充了欧盟药品法第 4 卷第 2 部分指南中所设定的销售规定，也适用于销售自己生产的原料药的分销商。Any manufacturing activities in relation to active substan
5、ces, including re-packaging, re-labelling or dividing up, are subject to Commission Delegated Regulation (EU) No 1252/2014 (3) and EudraLex Volume 4, Part II.所有与原料药相关的生产活动，包括再包装、再标签或分装均受法规(EU) No 1252/2014 (3)和欧盟药品法卷 4 第 2 部分的管理。Additional requirements apply to the importation of active substances,
6、as laid down in Article 46b of Directive 2001/83/EC.适用于原料药进口的额外要求在指令 2001/83/EC 第 46b 中列出。Distributors of active substances for medicinal products for human use should follow these guidelines as of 21 September 2015.人用药原料药分销商自 2015 年 9 月 21 日起应遵守本指南。CHAPTER 1 SCOPE第 1 章- 范围These guidelines apply to
7、distribution of active substances, as defined in Article 1(3a) of Directive 2001/83/EC, for medicinal products for human use. According to that provision, an active substance is any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used i
8、n its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis.这些指南适用于人用药活性物质的分销活动，该活动在指令 2001/83/EC 第 1（3a ）条款中进行了定义。根据该条款，
9、原料药是指将用于药品生产的单一物质或混合物质，当其用于生产时，成为发挥药理、免疫或代谢活动的药品的一种活性成分，可以恢复、矫正或修复生理功能或进行医学诊断。For the purpose of these guidelines, distribution of active substances shall comprise all activities consisting of procuring, importing, holding, supplying or exporting active substances, apart from brokering.本指南所指原料药分销活动包
10、括所有活动由采购、进口、存贮、供应或出口组成，中间商除外。These guidelines do not apply to intermediates of active substances.这些指南不适用于原料药的中间体。CHAPTER 2 QUALITY SYSTEM第 2 章-质量体系Distributors of active substances should develop and maintain a quality system setting out responsibilities, processes and risk management principles. Ex
11、amples of the processes and applications of quality risk management can be found in EudraLex Volume 4, Part III: GMP related documents, ICH guideline Q9 on Quality Risk Management (ICH Q9).原料药分销商应建立和维护质量体系，设定职责、流程和风险管理原则。在EUDRALEX 第 4 卷第 3 部分： GMP 相关文件，ICH 指南 Q9 质量风险管理中可以找到质量风险管理流程和应用实例。The quality
12、system should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. It should ensure that:质量体系应具有足够的有资质的人员，具备适当的充足的设施、设备和场所。它应保证： active substances are procured, imported, held, supplied or exported in a way that is compliant with the requi
13、rements of GDP for active substances; 原料药的生产、进口、存贮、供应和出口应符合原料药 GDP 要求 management responsibilities are clearly specified; 管理职责清楚界定 active substances are delivered to the right recipients within a satisfactory time period; 原料药在令人满意的时间内被发送给正确的收货人 records are made contemporaneously; 记录同步制作 deviations fr
14、om established procedures are documented and investigated; 偏出已建立的程序的偏差要记录并调查 appropriate corrective and preventive actions, commonly known as CAPA, are taken to correct deviations and prevent them in line with the principles of quality risk management; 应采取适当的纠正和预防措施，通常大家作为 CAPA，来纠正和防止偏差，保证符合质量风险管理原则
15、 changes that may affect the storage and distribution of active substances are evaluated. 可能对原料药存贮和销售有影响的变更应进行评估The size, structure and complexity of the distributors activities should be taken into consideration when developing or modifying the quality system.在建立和修改质量体系时，要考虑分销商活动的规模、组织结构和复杂程度。CHAPT
16、ER 3 PERSONNEL第 3 章-人员The distributor should designate a person at each location where distribution activities are performed who should have defined authority and responsibility for ensuring that a quality system is implemented and maintained. The designated person should fulfil his responsibilities personally. The designated person can delegate duties but not responsibilities.分销商应在每个实施分销活动的地点指定一个人，该人员应被授权并有责任保证实施和维护一个质量体系。指定的人员应亲自履行其职责。
