发布时间 : 星期日 文章EU GMP part1 chapter6 20141001实施-中英文更新完毕开始阅读
Ref. Ares(2014)968036 - 28/03/2014
Brussels, 28 March 2014
EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
欧盟药品法规第4卷 EU Guidelines for
Good Manufacturing Practice for
Medicinal Products for Human and Veterinary Use
人兽用药GMP欧盟指南
Part 1
Chapter 6: Quality Control 第1部分第6章：质量控制
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.
出版详细指南的法律依据：指令2001/83/EC第47条关于人药统一编码和2001/82/EC第51条关于兽药统一编码规定。本文对指令2003/94/EC中人药和91/412/EEC中兽药的药品GMP原则和指南解释提供指南。 Status of the document:Revision 文件状态：修订
Reasons for changes:变更理由
Inclusion of a new section on technical transfer of testing methods and other items such as Out Of Specification results.
包括检验方法的技术转移作为新章节，包括其它项目例如OOT结果。 Deadline for coming into operation:1 October 2014 生效日期：2014年10月1日 Principle原则
This chapter should be read in conjunction with all relevant sections of the GMP guide Quality Control is concerned with sampling, specifications and testing as well as the organisation, documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. Quality Control is not confined to laboratory operations, but must be involved in all decisions which may concern the quality of the product. The independence of Quality Control from Production is considered fundamental to the satisfactory operation of Quality Control. 本章应与GMP指南中所有相关章节一起解读。质量控制主要关注取样、质量标准和检测，同时也与组织机构、文件记录和放行程序相关，这些程序保证了必要和相关的测试。只有当产品和物料的质量被判定为可以接受时，物料才可以放行使用，产品才可以放行销售。质量控制不仅局限于化验室操作，还必须包括所有可能与产品质量相关的其它决定。质量控制独立于生产被认为是质量控制可以令人满意地操作的基础。 General通则
6.1 Each holder of a manufacturing authorisation should have a Quality Control Department. This department should be independent from other departments, and under the authority of a person with appropriate qualifications and experience, who has one or several control laboratories at his disposal. Adequate resources must be available to ensure that all the Quality Control arrangements are effectively and reliably carried out. 每一个生产许可持有人均应具有一个质量控制部门。该部门应独立于其它部门，由一个具有相应资质和经验的人管理，他/她可以管理一个或几个化验室。化验室应具有充分的资源，以保证所有检测要求能有效可靠地实施。
6.2 The principal duties of the head of Quality Control are summarised in Chapter 2. The Quality Control Department as a whole will also have other duties, such as to establish,
validate and implement all quality control procedures, oversee the control of the reference and/or retention samples of materials and products when applicable, ensure the correct labelling of containers of materials and products, ensure the monitoring of the stability of the products, participate in the investigation of complaints related to the quality of the product, etc. All these operations should be carried out in accordance with written procedures and, where necessary, recorded.
质量控制负责人基本职责在第2章里进行了概括。质量控制部门作为一个整体，还具有其它职责，例如建立、验证和实施所有质量控制程序，监督物料和产品的对照和/或留样，保证物料和产品容器上标签正确，保证对产品稳定性进行监控，参与和产品质量相关的客诉的调查等等。所有这些操作均应根据书面程序进行，必要时，应进行记录。
6.3 Finished product assessment should embrace all relevant factors, including
production conditions, results of in-process testing, a review of manufacturing (including packaging) documentation, compliance with Finished Product Specification and examination of the final finished pack.
成品的评估应综合所有相关的因素，包括生产条件、中控检测结果、生产（包括包装）文件审核、成品符合质量标准和最终包装检查。
6.4 Quality Control personnel should have access to production areas for sampling and investigation as appropriate.
质量控制人员应有权限进入生产区域进行取样，及适当的调查。 Good Quality Control Laboratory Practice优良质量控制化验室规范
6.5 Control laboratory premises and equipment should meet the general and specific requirements for Quality Control areas given in Chapter 3. Laboratory equipment should not be routinely moved between high risk areas to avoid accidental cross-contamination. In particular, the microbiological laboratory should be arranged so as to minimize risk of cross-contamination.
化验室设施和设备应符合第3章里给出的QC区域通用和特殊要求。为避免交叉污染事故，化验室设备一般不应该设计为需要常常在高风险区域之间移来移去。特别是微生物化验室的布置，应尽可能将交叉污染的风险降至最低。
6.6 The personnel, premises, and equipment in the laboratories should be appropriate to the tasks imposed by the nature and the scale of the manufacturing operations. The use of outside laboratories, in conformity with the principles detailed in Chapter 7, Contract Analysis, can be accepted for particular reasons, but this should be stated in the Quality Control records.
化验室的人员、设施、设备应与其检验任务和生产规模相当。在有特殊原因情况下，可以使用外部分化验室，但应符合第7章“外包分析”中的原则，并要在质量控制记录上说明。
Documentation文件
6.7 Laboratory documentation should follow the principles given in Chapter 4. An important part of this documentation deals with Quality Control and the following details should be readily available to the Quality Control Department:
化验室文件应符合第4章中给定的原则。这部分文件一个重要部分与质量控制相关，质量控制部门应很容易获得以下详细信息 i. Specifications; 质量标准
ii. Procedures describing sampling, testing, records (including test worksheets and/or laboratory notebooks), recording and verifying;
描述取样、检测、记录（包括检测原始记录表和/或化验室笔记本）、记录和确认情况
iii. Procedures for and records of the calibration/qualification of instruments and maintenance of equipment;
仪器校正/确认，设备维保程序和记录
iv. A procedure for the investigation of Out of Specification and Out Of Trend results; OOS和OOT结果调查程序
v. Testing reports and/or certificates of analysis; 检测报告和/或分析报告
vi. Data from environmental (air, water and other utilities) monitoring, where required; 环境（空气、水和其它设施）监控数据，必要时