欧盟GMP补充条例翻译2014.11.25
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25.11.2014 Official Journal of the European Union L 337/1 EN
II (Non-legislative acts)非法律形式
REGULATIONS 章则 COMMISSION DELEGATED REGULATION (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use
欧洲议会和委员会对人用药品活性物质 GMP 原则和指南的补充条例 (Text with EEA relevance) 本文与欧洲经济区有相关性 THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6November 2001 on the Community code relating to medicinal products for human use (1), and in particular the third paragraph of Article 47 thereof,
欧洲委员会：考虑到欧盟条约的效用性，包括（2001/83/EC）条例及 2001 年 11 月 6 号欧盟委员会颁布的人用药品管理规范，特别是 47 章第三章节：
Whereas: 鉴于 (1) All active substances manufactured in the Union, including active substances intended for export, should be manufactured in accordance with the principles and guidelines of good manufacturing practice for active substances which at present are set out in the technical guidelines on manufacturing of active substances published by the Commission. It is necessary to lay down principles and guidelines of good manufacturing practice for active substances in a legally binding act.
在欧盟，所有活性物质（包括出口活性物质）生产都应符合活性物质 GMP 原则和指L 337/2 Official Journal of the European Union 25.11.2014 EN
南，也就是委员会目前颁布的活性物质生产工艺指南。以具有法律约束力的形式来制定活性物质GMP原则和指南很有必要。
(2) In order to promote the use of harmonised standards at global level, principles and guidelines of good manufacturing practice for active substances should be laid down in line with the guidelines for active substances established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
为了提高全球协调标准的使用频率，活性物质 GMP 原则与指南的制定应与国际会议颁布的人用药品注册技术统一要求一致。
(3) Principles and guidelines of good manufacturing practice should be set out in relation to all issues, operations and processes that are key to determining the quality of active substances, such as quality management, personnel, premises and equipment, documentation, material management, production, in-process quality controls, packaging, labelling, laboratory controls, returns, complaints and recalls, contracting out and repackaging. In order to ensure compliance with those principles and guidelines, the manufacturers of active substances should be required to establish and implement an effective system for managing the quality of those substances.
制定GMP原则和指南应考虑影响活性物质质量的所有因素，包括关键操作及过程，例如质量管理、人员、厂房和设备、文件、物料管理、生产、中间过程控制、包装、标签、实验室、退货、投诉和 召回、委托生产和包装等等。为了确保这些因素的合规性，生产商应建立并实施一个有效的质量管 理系统。
(4) Personnel in unsanitary conditions, wearing unsuitable clothing or practicing potentially contaminating activities in the manufacturing area may compromise the quality of the active substance. This should be prevented by practicing sanitation and health habits that are appropriate to the manufacturing operations performed. Those practices should be provided for in the quality management system established by the manufacturer of the active substance.
人员不卫生，不适宜穿着或可能会引起污染的活动，在生产区，都可能会对产品质量造成影响。然而，在生产区，良好的卫生和健康习惯就可以避免人员对产品质量的影响。生产商应在质量管理体系中建立良好的卫生和健康习惯要求。 25.11.2014 Official Journal of the European Union L 337/3 EN
(5) In order to ensure an adequate quality of the active substance, it is necessary to minimise potential contamination and cross-contamination by requiring the use of facilities, production processes and containers designed for this purpose, as well as appropriate contamination controls.
为了确保产品质量，有必要减少因设备设施使用、生产过程以及容器引起的潜在污染和交叉污染，同时应有适当的污染控制程序。
(6) It is of particular importance to prevent cross-contamination when producing active substances harmful to human health. Contamination of other products with highly sensitising active substances could pose a serious threat to public health since exposure to these substances very often results in the development of hypersensitivity and allergic reactions. For that reason, manufacturing of those active substances should only be allowed to take place in separate production areas. The use of separate production areas may also be necessary for the production of active substances with the potential to be harmful to human health because of their potency or their infective or toxic nature. For those substances, the manufacturer should perform an assessment of the risks to human health and the need for separate production areas.
