EU GMP指南 第5章 生产
UROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Public Health and Risk Asssment
Medicinal products – quality, safety and efficacy
Brusls, 13 August 2014
Ares(2014)2674301
EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
EU Guidelines for
Good Manufacturing Practice for
Medicinal Products for Human and Veterinary U
Part 1
我们赢了Chapter 5: Production
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如何锻炼核心力量人兽药EU GMP指南第1部分第5章：生产
Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human u and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human u and Directive 91/412/EEC for veterinary u.
Status of the document: Revision.
Reasons for changes: Changes have been made to ctions 17 to 20 to improve the guidance on prevention of cross-contamination and to refer to toxicological asssment guidance. Changes were also introduced in ctions 26 to 28 on the qualification of suppliers in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP. The changes include supply chain traceability. Section (33) is inrted to clarify and harmoni expectations of manufacturers regarding the testing of starting materials while ction (68) introduces guidance on notification of restrictions in supply.
完成用英语怎么说变更理由：对17-20条进行变更，以改进指南中防止交叉污染的部分，及引用毒理学评估指南。还增加了26-28条关于供应商确认部分，以反映上市许可持有人所承担的保证活性物质根据GMP要求生产的责任。变更包括供应链可追溯性。加入第33条，以澄清并保持关于原辅料生产商期望一致性，增加保质期最长的食物68条中引入了供应受限通知的内容。
Deadline for coming into operation: 1 March 2015
生效日期：2015年3月1日
Principle
Production operations must follow clearly defined procedures; they must comply with the principles of Good Manufacturing Practice in order to obtain products of the requisite quality and be in accordance with the relevant manufacturing and marketing authorisations.
生产操作必须按规定的程序进行，必须符合GMP的原则，以确保产品达到所要求的质量，并满足相关生产许可和上市许可的要求。
General 通则
5.1 Production should be performed and supervid by competent people.
应由有能力的人员进行生产操作和生产监督。
5.2 All handling of materials and products, such as receipt and quarantine, sampling, storage, labelling, dispensing, processing, packaging and distribution should be done in accordance with written procedures or instructions and, where necessary, recorded.
干桂圆物料和产品的处理，如接收和待检、取样、贮存、发料、生产、包装和销售等应按照书面规程或指令进行，并作必要的记录。
5.3 All incoming materials should be checked to ensure that the consignment corresponds to the order. Containers should be cleaned where necessary and labelled with the prescribed data.
应对所有的进货进行检查，以确保到货的物料与订单相符，必要时对包装进行清洁，并贴签标明规定的内容。
5.4 Damage to containers and any other problem which might adverly affect the quality of a material should be investigated, recorded and reported to the Quality Control Department.
对包装破损及其它任何可能影响物料质量的问题应进行调查和记录，并报告质量控制部门。
5.5 Incoming materials and finished products should be physically or administratively q
uarantined immediately after receipt or processing, until they have been relead for u or distribution.
接收的物料和生产出的成品应立即进行物理或行政隔离，直至其被放行使用或销售。
5.6 Intermediate and bulk products purchad as such should be handled on receipt as though they were starting materials.
对于外购的中间体和待包装产品，在接收时视同原辅料接收。
5.7 All materials and products should be stored under the appropriate conditions established by the manufacturer and in an orderly fashion to permit batch gregation and stock rotation.
所有物料和产品都应按生产厂家确定的合适的条件贮存，并有序存放，以使批次间有区分及方便库存周转。支离破碎造句
5.8 Checks on yields, and reconciliation of quantities, should be carried out as necessary to ensure that there are no discrepancies outside acceptable limits.
应检查收率和数量平衡，确保差异未超出可接受的限度。
5.9 Operations on different products should not be carried out simultaneously or concutively in the same room unless there is no risk of mix-up or cross-contamination.
不同产品的生产操作不得在同一房间内同时或连续进行，除非该操作不会产生混淆或交叉污染风险。
5.10 At every stage of processing, products and materials should be protected from microbial and other contamination.
在生产的所有阶段，均应保护产品和物料不受微生物和其它污染。
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