EUROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE—GENERAL
Public Health and Risk Asssment
Medicinal Product – quality, safety and efficacy
Brusls, 16 August 2013
EudraLex鼻息肉的最佳治疗方法
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
Chapter 2： Personnel
人药与兽药GMP指南 第2章:人员
霓虹心Legal basis for publishing the detailed guidelines:苹果xp 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.尽量的近义词>初二下册语文
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。
动物大全图片Status of the document: Revision
普通二轮摩托车文件状态：修订
包头美食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 ction 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 The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. Senior management should determine and provide adequate and appropriate resources （human， financial， materials, facilities and equipment） to implement and maintain the quality management system and continually improve its effectiveness。 The responsibilities placed on any one individual should not be so extensive as to prent any risk to quality.
生产商应具备足够数量的人员，人员应具备必要的资质和实践经验。高层管理应决定和提供充足的和适当的资源(人员、经济、物料、厂房设施和设备)，以实现和维护质量管理体系，并持续提高其有效性。给单个人员的职责不应太多，造成对质量的风险.
2.2 The manufacturer must have an organisation chart in which the relationships between the heads of Production， Quality Control and where applicable Head of Quality Assurance or Quality Unit referred to in point 2。5 and the position of the Qualified Person(s) are clearly shown in the managerial hierarchy.
生产商必须具备组织机构图,根据2.5内容在其中标明生产负责人、QC负责人和QA或质量部门负责人的关系，QP的位置应在管理层级中明确标示。
2.3 People in responsible positions should have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of tho personnel concerned with the application of Good Manufacturing Practice.
承担职责的人员应具有指定的任务，任务应在书面岗位职责中记录,并具备足够的权限实现其职责。其职责可以转授予具有令人满意的资质层次的人员。与实施GMP相关人员的职责之间不应有漏项或无法解释的重叠.
2。4 Senior management has the ultimate responsibility to ensure an effective quality management system is in place to achieve the quality objectives， and, that roles， responsibilities， and authorities are defined， communicated and implemented throughout the organisation. Senior management should establish a quality policy that describes the overall intentions and direction of the company related to quality and should ensure continuing suitability and effectiveness of the quality management system and GMP compliance through participation in management review。
高层管理对保证具备质量管理体系以达到质量目标具有最终职责，其角色、职责、权限应在组织范围内进行定义、沟通和实施。高层管理应建立质量方针，在其中描述公司整体质量相关意图和方向，应通过参与管理评审保证质量管理体系持续适用和有效性,保证GMP符合性。
Key Personnel 关键人员
2.5 Senior Management should appoint Key Management Personnel including the head of Production， the head of Quality Control, and if at least one of the persons is not responsible for the duties described in Article 51 of Directive 2001/83/EC[1]， an adequate number, but at least one， Qualified Person（s） designated for the purpo. Normally, key posts should be occupied by full-time personnel. The heads of Production and Quality Control must be independent from each other. In large organisations, it may be necessary to delegate some of the functions listed in 2。6 and 2.7. Additionally depending on the size and organizational structure of the company， a parate Head of Quality Assurance or Head of the Quality Unit may be appointed。 Where such a function exists usually some of the responsibilities described in 2.6, 2。7 and 2.8 are shared with the Head of Quality Control and Head of Production and nior management should therefore take care that roles, responsibilities, and authorities are defined.
