欧盟GMP指南 第5章生产(中英文20150123)

EU GMP 第1部分第5章生产

——增加基因毒性的评估生效时限

2015-02-25 11:50:00

（粉色字为2015年1月23日新增内容，红字斜体为2014年8月13日修订内容）

EUROPEAN COMMISSION

HEALTH AND CONSUMERS DIRECTORATE-GENERAL

Public Health and Risk Assessment

Medicinal products – quality, safety and efficacy

Ref. Ares(2015)283689 - 23/01/2015

Brussels, 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 Use

Part 1

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 use 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 use and Directive 91/412/EEC for veterinary use.

Status of the document: Revision [a]

Reasons for changes: Changes have been made to sections 17 to 20 to improve the guidance on prevention of cross-contamination and to refer to toxicological assessment guidance. Changes were also introduced in sections 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 inserted to clarify and harmonise expectations of manufacturers regarding the testing of starting materials while section (68) introduces guidance on notification of restrictions in supply.

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68条中引入了供应受限通知的内容。

Deadline for coming into operation: 1 March 2015. However, the toxicological evaluation mentioned in section 20 has to be carried out:

生效日期：2015年3月1日。 但是，在第6部分提到的基本毒性的评估实施日期如下：

from 1 June 2015 onwards for any medicinal product newly introduced into shared

manufacturing facilities;

共用生产设施中新引入的所有药品自2015年6月1日起，

before 1 December 2015 for medicinal products already produced in a shared manufacturing

facility producing only medicinal products for human use or both producing medicinal products for human use and veterinary medicinal products on 31 May 2015;

仅生产人用药品或人药兽药均生产的共用生产设施中，在2015年5月31日前已引入的药

品自2015年12月1日起实施

before 1 June 2016 for veterinary medicinal products already produced in a shared

manufacturing facility producing only veterinary medicinal products on 31 May 2015.

仅生产兽药产品的共用生产设施中，在2015年5月31日前已引入的兽药产品自2016年6

月1日起实施

Principle原则

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 supervised 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.

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 adversely 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 quarantined

immediately after receipt or processing, until they have been released for use 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 purchased 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 segregation 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。

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。

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