EU-GMP指南-第1部分第2章-人员.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 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 present 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 those 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 these persons is not responsible for the duties described in Article 51 of Directive 2001/83/EC1, an adequate number, but at least one, Qualified Person(s) designated for the purpose. 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 separate 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 senior management should therefore take care that roles, responsibilities, and authorities are defined.高层管理应任命关键管理人员，包括生产负责人、QC负责人，如果这些人中的至少一个不承担2001/83/EC第51款中描述的职责，则应有充足数量，至少一个人应任命为QP。一般来说，关键岗位应由全职人员担任。生产和QC负责人必须相互独立。如果组织机构庞大，可能需要任命2.6和2.7中所列的职责人员。另外，依据各公司规模和组织结构不同，可能需要分别任命QA或QU负责人。如果存在这种功能，一般2.6，2.7和2.8中描述的职责会由QC负责人和生产负责人分担，高层管理则需要保证对这些职位的角色、责任和权限进行定义。2.6 The duties of the Qualified Person(s) are described in Article 51 of Directive 2001/83/EC, and can be summarised as follows:QP的责任在2001/83/EC第51款中已有描述，可以归纳如下a) for medicinal products manufactured within the European Union, a Qualified Person must ensure that each batch has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorisation2;在欧共体之内生产的药品，必须有一具备资格人员QP，保证每批产品均按照其所在成员国法规和上市许可的要求进行生产和检查。(b) in the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the European Union a Qualified Person must ensure that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation. The Qualified Person must certify in a register or equivalent document, as operations are carried out and before any release, that each production batch satisfies the provisions of Article 51.如果药品来源于欧共体之外的国家，不管该产品是否在欧共体内生产，QP必须保证所有生产批次均在某个成员国接受了全面质量检查，至少对所有活性物质进行了定量分析，进行了所有其它必要的检测或检查，以保证药品符合上市许可的要求。QP必须签发一份登记的文件或等同的文件，以保证在放行前所有操作均已完成，所有生产批准均满足第51款的要求。The persons responsible for these duties must meet the qualification requirements laid down in Article 493 of the same Directive, they shall be permanently and continuously at the disposal of the holder of the Manufacturing Authorisation to carry out their responsibilities.上述职责负责人的资质应符合同样法令第49款中的要求，人员应在上市许可持有人公司长期持续行使其职责。The responsibilities of a Qualified Person may be delegated, but only to other Qualified Person(s).QP的职责可以转授权，但只能是转授权给其它QP。Guidance on the role of the Qualified Person is elaborated in Annex 16.QP的角色指南在附件16中说明。2.7 The head of the Production Department generally has the following responsibilities:生产部门负责人一般具有如下职责i. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality;保证产品的生产和存贮符合适当的文件的要求，以获得所需的品质。ii. To approve the instructions relating to production operations and to ensure their strict implementation;批准与生产操作有关的指令，保证其被严格遵守。iii. To ensure that the production records are evaluated and signed by an authorized person;保证生产记录由经授权的人员评估并签字。iv. To ensure the qualification and maintenance of his department, premises and equipment;保证生产部门、厂房设施和设备得到确认和维护。v. To ensure that the appropriate validations are done;保证已进行了适当的验证。vi. To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.保证生产部门人员所需的初始和后续培训已实施，满足需要。2.8 The head of Quality Control generally has the following responsibilities:质量控制负责人一般具有如下职责i. To approve or reject, as he sees fit, starting materials, packaging materials, intermediate, bulk and finished products;批准或拒收，由负责人判定，起始物料、包装材料、中间体、散装和制剂成品。ii. To ensure that all necessary testing is carried out and the associated records evaluated;保证实施所有必须的测试，并对相关记录进行评价。iii. To approve specifications, sampling instructions, test methods and other Quality Control procedures;批准质量标准、取样指令、检验方法和其它质量控制程序。iv. To approve and monitor any contract analysts;批准及监控所有合同分析人员v. To ensure the qualification and maintenance of his department, premises and equipment;保证质量部门、设施和设备得到确认和维护vi. To ensure that the appropriate validations are done;保证已进行适当的验证vii. To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.保证质量部门人员所需的初始和后续培训已实施，满足需要。Other duties of Quality Control are summarised in Chapter 6.质量控制的其它职责在第6章中进行了归纳。2.9 The heads of Production, Quality Control and where relevant, Head of Quality Assurance or Head of Quality Unit, generally have some shared, or jointly exercised, responsibilities relating to quality including in particular the design, effective implementation, monitoring and maintenance of the quality management system. These may include, subject to any national regulations:生产部门、质量控制部门负责人，及质量保证或质量部门负责人（适当时），一般会共同承担，或联合进行一些与质量相关的职责，包括质量管理体系的设计、有效实施、监控和维护。这些职责可能会包括，受到所有国家法规的约束。i. The authorisation of written procedures and other documents, including amendments;书面程序和其它文件，包括修订内容的批准ii. The monitoring and control of the manufacturing environment;生产环境的监控和控制iii. Plant hygiene;工厂卫生iv. Process validation;工艺验证v. Training;培训vi. The approval and monitoring of suppliers of materials;原料供应商的批准和监控vii. The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities;对分包生产商和提供其它GMP相关外包服务提供商的批准和监控，viii. The designation and monitoring of storage conditions for materials and products;原料和产品存贮条件的设计和监控ix. The retention of records;记录保存x. The monitoring of compliance with the requirements of Good Manufacturing Practice;GMP符合性监控xi. The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality;检查、调查和取样，以监控产品质量影响因素xii. Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement参与工艺性能、产品质量、质量管理体系和倡议持续改进的管理评审xiii. Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.保证及时有效沟通，加强现有向适当级别管理层提出质量议题的通道Training 培训2.10 The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.生产商应该给所有在生产和存贮区工作的人员和化验室工作的人员（包括技术人员、维修人员和清洁人员）以及其他工作行为可能会影响到产品质量的人员进行培训。2.11 Besides the basic training on the theory and practice of the quality management system and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.对新进的人员除了进行GMP的理论和实践方面的基本培训外，还要进行与所承担的工作直接相关的培训。培训应该是一项持续进行的工作，并需要定期对培训的结果进行评估。应制定培训计划，并由生产负责人或质量负责人批准。培训活动要进行记录。2.12 Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitising materials are handled, should be given specific training.在污染高危区域工作的人员，如洁净区或处理高活性、毒性、感染或过敏性材料的区域，需要进行特别培训。2.13 Visitors or untrained personnel should, preferably, not be taken into the production and quality control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.参观人员和未经培训的人员，最好不要进入生产区或质量控制区，如果不可避免，他们必须事先进行培训，特别是针对人员洁净和个人防护用品的使用方面。同时陪同他们进行密切指导。2.14 The pharmaceutical quality system and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions.对药品质量体系的概念，和所有其他有助于理解和应用的方法，都应该在培训中进行全面的讨论。Personnel Hygiene 人员卫生2.15 Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. Hygiene programmes should be promoted by management and widely discussed during training sessions.应建立详细的卫生清洁程序，适用于工厂的各种需要。应包括健康、清洁方法和工作服使用方面的操作程序。在生产区或质量控制区工作人员必须对这些程序理解并严格执行，卫生规程必须由管理层进行审定，并在培训过程中进行广泛的讨论。2.16 All personnel should receive medical examination upon recruitment. It must be the manufacturers responsibility that there are instructions ensuring that health conditions that can be of relevance to the quality of products come to the manufacturers knowledge. After the first medical examination, examinations should be carried out when necessary for the work and personal health.所有人员在入职时均应进行健康检查。生产商必须根据自己的产品情况，制定相关的人员卫生要求。在首次健康检查之后，还要在工作需要的时候或个人健康状况需要的时候进行检查。2.17 Steps should be taken to ensure as far as is practicable that no person affected by an infectious disease or having open lesions on the exposed surface of the body is engaged in the manufacture of medicinal products.采取有效的防御措施，保证参与药品生产人员没有传染病和体表暴露伤口。2.18 Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out.所有进入生产区域的人员均应着与生产操作相适当的防护性工作服2.19 Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in