SMF编写及内容要求注释-EN+CN.docx

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1、EudraLexThe Rules Governing Medicinal Products in the European Union欧盟药事法规Volume 4第4卷Brussels, 10 December 20092009年12月10日，布鲁塞尔EU Guidelines to欧盟指南Good Manufacturing Practice Medicinal Products for Human and Veterinary Use人用药品及兽药生产质量管理规范Part III第III部分Explanatory notes for pharmaceutical manufacturer

2、s on the preparation of a Site Master File and content of a Site Master File药品制造企业现场管理档案（SMF）内容及编写要求注释翻译：徐禾丰2009年12月，第1版Draft agreed by GMP/GDPInspectors Working GroupsGMPGDP检查员工作组批准草案September 20092009年9月Release for public consultation发放征求意见15 December 20092009年12月15日Deadline for comments entr-gmpe

3、c.europa.eu and ADMGMDPema.europa.eu提交意见给 entr-gmpec.europa.eu与ADMGMDPema.europa.eu的最后期限31 March 20102010年3月31日Final text agreed by GMP/GDP Inspectors Working GroupsGMPGDP检查员工作组批准最后文本Adopted by European Commission欧盟委员会批准Deadline for coming into operation实施运行最后期限The Site Master File concept has been

4、developed by PIC/S and has become a standard expectation of EU authorities. Following a recent revision of the explanatory notes by PIC/S, it has been proposed that the status of the Site Master File is more formally linked to the EU regulatory framework.现场管理档案的概念由PICS开发，并已经成为欧盟当局的一个标准的期望。继最近PICS修订解

5、释性说明，已经建议SMF地位更加正式地连接到欧盟药政法规架构中。It is proposed that a new informational Part III of the EU GMP Guide is created for documents which are not themselves GMP guidelines and have no statutory force but which complement the GMP guidelines and related regulatory procedures such as, in this case, inspectio

6、ns.建议欧盟GMP指南第III部分编制为新的信息文件，但其本身不是一个GMP指南，也不具有法定效力，但作为GMP指南的一个补充和相关的药政程序，例如，检查。It is expected that in the future, further documents will be added to the new Part III and that such documents would be included following public consultation.希望在未来将有更多的文件添加到新的第III部中，并且这些文件也将包括在发放征求意见中。The document is ide

7、ntical to the content of the Site Master File by PIC/S and is published in parallel.该文件与PICS的现场管理档案内容一致，并平行发布。Table of contents目录1.INTRODUCTION.2.PURPOSE.12目的3.SCOPE.23范围24.CONTENT OF A SITE MASTER FILE.24现场管理档案内容Annex附件EU-GMP Part III(20091215) Site Master File欧盟GMP第III部分（20091215）现场管理档案1.INTRODUCT

8、ION1简介1.1The Site Master File is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the company, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and

9、 any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, a Site Master File need only describe those operations,e.g.analysis,packaging,etc.现场管理档案由制造企业编写，包括关于质量管理方针与公司活动、指定现场进行药品制造运行、和或质量控制、以及在相邻或附近的建筑里进行的任何相关操作的具体信息。如

10、果现场只进行药品生产的部分活动，现场管理档案只需描述这些操作，例如，分析、包装等。1.2When submitted to a regulatory authority, the Site Master File should provide clear information on the manufacturers GMP related activities that can be useful in general supervision and in the efficient planning and undertaking of GMP inspections. 当提交给药政机构

11、时，现场管理档案应当提供制造商GMP相关活动的清晰资料，这些资料在一般监管、有效地规划以及采取GMP检查中十分有用。1.3A Site Master File should be detailed enough but, as far as possible, not exceed approximately twenty-five to thirty A4 pages plus appendixes.现场管理档案应当足够详细，加上附录，用A4纸，应不超过大约25到30页。1.4The Site Master File should be a part of documentation bel

12、onging to the quality management system of the manufacturer and kept updated accordingly. The Site Master File should have an edition number and effective and expiry dates. It should be subject to regular review to ensure that it is up to date and representative of current activities. The format and

13、 headings should follow these guidance notes.现场管理档案应当属于制造企业质量管理体系文件的一部分，并相应地保持最新。现场管理档案应当有版本编号以及有效期。其应当定期进行审核，以确保它是最新，并代表当前的活动。格式和标题应该遵守这些指南的注释。1.5Wherever possible,simple plans, outline drawings or schematic layouts should be used instead of narrative. These plans etc should fit on A4 sheets of pap

14、er and copies should be readable.如果可能，用简单的平面图，略图或者图解代替文字叙述。这些平面图等应该印在A4纸上，印制应当清晰。2.PURPOSE2目的The aim of these Explanatory Notes is to guide the manufacturer of medicinal products in the preparation of a Site Master File that can be useful to the regulatory authority in planning and conducting GMP in

15、spections.本注释的目的是为了指导药品制造企业编写现场管理档案，该档案有利于管理当局策划和执行GMP检查。翻译：徐禾丰2009年12月，第1版第1页下载高清无水印EU-GMP Part III(20091215) Site Master File欧盟GMP第III部分（20091215）现场管理档案3.SCOPE3范围These Explanatory Notes apply to the preparation and content of the Site Master File. Refer to national regulatory requirements to estab

16、lish whether it is mandatory for manufacturers of medicinal products to prepare a Site Master File and supply it and version updates to the Supervisory Authority.本注释适用于现场管理档案的编写及其内容要求。请参阅国家法规要求，以确定是否强制药品制造企业制作现场管理档案，并向监管当局提交与更新版本。These Explanatory Notes apply for all kind of manufacturing operations

17、 such as production, packaging and labelling, testing, relabelling and repackaging of all types of medicinal products as well as active pharmaceutical ingredients. This guide could also be used in the preparation of a Site Master File or corresponding document by Blood and Tissue Establishments.这些注释

18、应用于所有类型的制造操作，例如，所有类型的产品以及原料药的生产、包装与贴签、测试、再贴签及再包装。本指南还可用于血液与组织机构的现场管理档案或相应文件的编制。4.CONTENT OF A SITE MASTER FILE4现场管理档案内容Refer to Annex for the format to be used.所采用格式参见附件。翻译：徐禾丰2009年12月，第1版第2页EU-GMP Part III(20091215) Site Master File欧盟GMP第III部分（20091215）现场管理档案Annex附件CONTENT OF A SITE MASTER FILE现场管理

19、档案内容1.GENERAL INFORMATION ON THE COMPANY公司一般信息1.1Contact information on the firm 公司联络信息Name and official address of the company;公司名称与官方地址；Names and street addresses of the site,buildings and production units; 现场、建筑与生产部门名称与街道地址；Contact information of the company including 24 hrs telephone number of t

20、he contact personnel in the case of product defects or recalls;.公司联络信息，包括在产品缺陷或召回时24小时联系人电话号码；Identification number of the site such as e.g. DUNS, if available; 如果有，该现场识别号码，例如，邓白氏公司号码；GPS details.GPS详细情况。1.2Pharmaceutical manufacturing activities as licensed by the Competent Authorities. 官方许可的药品制造活动

21、Brief description of manufacture, import, export, distribution and other activities as authorized by the relevant Competent Authorities including foreign authorities with authorized dosage forms/activities,respectively;简要描述相关官方所许可的制造、进口、出口、分销与其它活动，也包括国外官方许可的剂型活动；Copy of the valid manufacturing autho

22、risation issued by the relevant Competent Authority and, if available, also for API manufacturers in Appendix 1;or when applicable, reference to EudraGMP.相关官方签发的有效制造授权书副本，如果有，也适用于附录1的原料药制造企业；适用时，可参考EudraGMP。翻译：徐禾丰2009年12月，第1版第3页下载高清无水印EU-GMP Part III(20091215) Site Master File欧盟GMP第III部分（20091215）现场

23、管理档案Type of products currently manufactured on-site (list in Appendix 2); 当时现场所制造产品的类型（列于附件2）；General information if toxic or hazardous(i.e. with high pharmacological activity and/or with sensitising properties) substances are handled on the site;现场所处理的有毒或有害（例如，高药理活性，和或，敏感性质）物质一般信息；Key parameters (e

24、.g. toxicological, pharmacological) considered for the identification of toxic or hazardous substances handled on the site.现场所处理的有毒或有害物质所考虑关键参数（例如，毒理学、药理学）；Information of supervision of competent authorities, dates and outcome of latest GMP-inspections. A copy of current GMP certificate (Appendix 3)

25、 or reference to EudraGMP, should be included,if available.主管当局监督信息，日期及最新的GMP检查结果信息。如果可用，应当包括一份最新的GMP证书（附件3），或参考EudraGMP。1.3Any other manufacturing activities carried out on the site 在该现场进行的其它制造活动Description of non-pharmaceutical activities on-site,if any. 现场的非药品活动描述，如果有。2.QUALITY MANAGEMENT SYSTEM

26、OF THE COMPANY 公司质量管理体系2.1Description of the quality management system of the company 公司质量管理体系的描述Information of the quality management systems run by the company and reference to the relevant standards (as ISO,ICH.);公司所运行的质量管理体系信息以及参考的相关标准（例如，ISO、ICH.);Responsibilities related to the maintaining of

27、quality system including senior management;维护质量体系的相关责任，包括高级管理层；Information of accredited and certified activities carried out by the company, including dates and contents of accreditations, names of accrediting bodies.该公司进行的任命与证明活动信息，包括日期与任命内容、任命人的名称。翻译：徐禾丰2009年12月，第1版第4页EU-GMP Part III(20091215) Si

28、te Master File欧盟GMP第III部分（20091215）现场管理档案2.2Quality policy of the company公司质量方针Brief description of elements of the quality management system e.g. organisational structure, quality manual (or equivalent documentation), responsibilities,procedures, processes;简要描述质量管理体系要素，例如，组织结构、质量手册（或等效文件）、职责、程序、过程；

29、Description of system of product quality reviews and management review programme;描述产品质量审核系统与管理评审程序；Brief description of validation and change control policies of the company. 简要描述公司的验证与变更控制方针。2.3.Release procedure of finished products成品放行程序Name(s) of responsible person(s) / Qualified Person(s) respo

30、nsible for batch certification and releasing procedures;负责批认证与放行程序的责任人产品放行人姓名.eneral description of batch certification and releasing procedure;批认证与放行程序的总体描述；Details of products for which the control strategy employs PAT and/or Real Time Release or Parametric Release and a brief description of the p

31、rocedures employed;应用PAT，和或，实时放行或参数放行控制策略的产品详细情况，以及所使用的程序；Brief description of Quality Control Departments activities in the release of finished products e.g. if the review of batch documentation and release of final documentation takes place in this department;简要描述质量控制部门在产品放行中的活动，例如，是否进行批文件的审核以及是否最

32、终放行本部门文件。Role of Authorised Person/ Qualified Person in quarantine and release of finished products and in assessment of compliance with the Marketing Authorisation. QP activities should be specified, including arrangements when several QPs are involved;授权人产品放行人在待检与放行以及上市许可一致性评估中的角色。产品放行人的活动应当具体，如涉及

33、几个产品放行人时，应当描述其工翻译：徐禾丰2009年12月，第1版第5页下载高清无水印EU-GMP Part III(20091215) Site Master File欧盟GMP第III部分（20091215）现场管理档案作安排；Arrangements for the handling of rejected materials and products.处理不合格物料与产品的安排。2.4Qualification policy for contractors and starting materials manufacturers and other parties involved i

34、n the supply chain对承包企业、起始物料制造企及在供应链中所涉及的其他方的确认方针When applicable,brief summary of the QRM approach for the external audit program;如果可能，简要汇总对外部审计程序的质量风险管理方法；General policy for the control strategy of starting materials;起始物料控制策略的总方针；Brief description of the quality systems used to qualify contractors,

35、 API manufacturers and suppliers, and other critical materials suppliers, including details of any associated audit and vendor qualification programmes, and the application of any Quality Risk Management principles;简要描述用来确认承包企业、原料药制造企业与供应企业，以及其它关键物料供应企业的质量体系，包括任何相关的审计及客户确认程序，以及质量风险管理原则的应用；Measures t

36、aken to ensure that products manufactured are compliant with TSE (Transmitting animal spongiform encephalopathy) guidelines.保证产品制造符合TSE（动物传染脑海绵状病）指南所采取的措施。2.5Quality Risk Management Policy of the company 公司质量风险管理方针Brief description of QRM policy of the company;简要描述公司的质量风险管理方针；Scope and focus of QRM

37、including brief description of any activities which are performed at corporate level, and those which are performed locally. Details should be provided as to whether the system operates across site or limited in scope. Any application of the QRM system to assess continuity of supply should be discus

38、sed;质量风险管理的范围与焦点，包括简单描述在公司层以及基层进行的任何活动。应当详细描述系统是否跨生产场所或有限定范围。评估供应连续性的质量风险管理系统的任何应用均应被讨论。Responsibilities within QRM system and integration of QRM system in the overall quality system;翻译：徐禾丰2009年12月，第1版第6页EU-GMP Part III(20091215) Site Master File欧盟GMP第III部分（20091215）现场管理档案质量风险管理体系的职责，以及全面整合质量风险管理到质量

39、管理体系中。Description how the identification,assessment,control, communication and review of risks is carried out under the QRM system.描述在质量风险系统下如何对风险进行辨识、评估、控制、沟通与审核。2.6Documents and records stored or archived off-site (including pharmacovigilance data)不在现场存放或归档的文件与记录（包括药物警戒资料）List of documents/records

40、;文件记录目录；Name and address of storage site;存储现场的名称与地址；Time required retrieving documents.3.PERSONNEL人员Organisation chart showing the arrangements for quality management, production and quality control in Appendix 4 including senior management and Qualified Person(s);显示质量管理、生产和质量控制安排的组织机构图，见附录4包括高层管理人员

41、和产品放行人；Number of employees engaged in the quality management, production, quality control,storage and distribution respectively;从事质量管理、生产、质量控制、储存与分销的人员数量；Key personnel; qualifications andexperiencerequirementsand responsibilities;关键人员；资历与经验要求以及责任；Short description of training policy of the company;

42、initial and in-service training programmes, qualification procedure of personnel;简短描述公司的培训方针；初始与在职培训程序，以及人员确认程序；Health requirements for personnel engaged in production and in special activities;翻译：徐禾丰2009年12月，第1版第7页下载高清无水印EU-GMP Part III(20091215) Site Master File欧盟GMP第III部分（20091215）现场管理档案从事生产与特殊活动

43、的人员健康要求；Gowning and laundry policy of the company.公司的服装更换以及洗涤方针。4.PREMISES AND EQUIPMENT厂房与设备4.1Premises厂房Short description of plant; size of the site, type and age of buildings; 对工厂的简要描述：现场大小、建筑的类型与年龄；Simple plan or description of manufacturing areas with indication of scale (architectural or engin

44、eering drawings are not required);简单绘制或描述制造区域的规模（不需要建筑或工程图纸）；Lay out and flow charts of the production area should be provided in Appendix 5. They should show the room classification and pressure differentials between adjoining areas and indicate the production activities of the rooms. The productio

45、n operations for each product type/ dosage forms and department/process line types, including the steps for sampling and information related the open/closed phased or isolators used, should be presented in the Appendix;应当在附件5中提供生产区域的平面图与流程图。在平面图中应显示房间的种类、相临区域房间的压力差，并指出该房间的生产活动。应当在附件中展示每种产品类型剂型的生产操作，

46、以及部门加工线类型，包括取样步骤与开放密闭阶段或使用隔离器相关的信息也应描述在附录里；Description of special areas for the storage and handling of highly toxic, hazardous and sensitising materials, if applicable;如果有，描述储存与处理高毒性、危险性与敏感物料的特殊区域；Brief description of warehouses,storage areas and specific storage conditions if needed;简要描述仓库、储存区，如果需

47、要，特殊储存条件；If different buildings are used for domestic and export products, list the buildings.如果内销与出口产品使用不同的建筑，列明建筑。4.1.1Brief description of ventilation systems简要描述通风系统翻译：徐禾丰2009年12月，第1版第8页EU-GMP Part III(20091215) Site Master File欧盟GMP第III部分（20091215）现场管理档案Design criteria of the system e.g. Specification of the air supply, temperature, humidity, pressure differentials and air change rates, policy of air recirculation (%);系统设计标准，例如，供应气体规格标准、温度、湿度、压力差以及换气率、空气循环方针（