EUGMPpart1chapter220140216实施-中英文.docx

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERALPublic Health and Risk AssessmentMedicinal Product – quality, safety and efficacyBrussels, 16 August 2013EudraLexThe Rules Governing Medicinal Products in the European UnionVolume 4EU Guidelines forGood Manufacturing Practice forMedicinal Products for Human and Veterinary UsePart 1Chapter 2: Personnel人药与兽药GMP指南第2章：人员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.指南细则出版的立法基础：2001/83/EC法令第47款对人用药品的相关要求，2001/82/EC法令第51款兽用药相关的欧共体法规。本文件主要是2003/94/EC法令对人用药和91/412/EEC对兽用药品的GMP原则和指南的解释。Status of the document:Revision文件状态：修订Reasons for changes:Changes have been made in order to integrate the principles of “Pharmaceutical Quality System” as described in the ICH Q10 tripartite guideline. A section has been added on consultants变更理由：变更是为了整合ICH Q10三方协调指南中所描述的“药品质量体系”的原则。增加了顾问部分。Deadline for coming into operation:16 February 2014实施最后期限：2014年2月16日Principle原则The correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.药品的正确生产依赖于人。因此，生产商应配备充足的有资质的人员承担所有工作。所有员工应明确个人应承担的职责并有书面记录。所有人员应明白与其职责相关的GMP的原则，接受初始及后续培训，包括与其工作相关的卫生要求。General通则2.1 Th