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Content of Site Master File 现场主文件清单 1. GeneralInformation on the Manufacturer 企业总体情况 1.1 Contactinformation on the manufacturer 企业联系信息 - Nameand official address of the manufacturer; 企业名称、注册地址； - Namesand street addresses of the site, buildings and production units located on thesite; 企业生产工厂以及工厂内建筑及生产车间名称和地址； - Contactinformation of the manufacturer including 24 hrs telephone number of thecontact personnel in the case of product defects or recalls; 企业联系方式（包括出现产品缺陷或召回事件时24小时联系人电话）; - Identificationnumber of the site as e.g. GPS details, D-U-N-S (Data Universal NumberingSystem) Number (a unique identification number provided by Dun& Bradstreet)of the site or any other geographic location system. 现场识别号码，例如GPS详细情况，D-U-N-S号码（数据通用编号系统）（一个由Dun& Bradstreet提供的独特识别号码）或者任何其他地理定位系统。 1.2 Authorisedpharmaceutical manufacturing activities of the site. 药品生产许可范围 - Copyof the valid manufacturing authorization issued by the relevant CompetentAuthority in Appendix 1; or when applicable, reference to the Eudra GMPdatabase. If the Competent Authority does not issue manufacturing authorizations,this should be stated; 附件1中提供相关监管机构签发的有效生产许可文本复印件，必要时，可参考EudraGMP数据库。如遇监管机构不签发生产许可情况，应予以说明。 - Briefdescription of manufacture, import, export, distribution and other activitiesas authorised by the relevant Competent Authorities including foreignauthorities with authorized dosage forms/activities, respectively; where notcovered by the manufacturing authorization; 简要描述由相关监管机构许可的生产、进口、出口、分销和其他活动，包括许可文件中没有提及的国外机构许可的剂型/生产活动等; - Typeof products currently manufactured on-site (list in Appendix 2) where notcovered by Appendix 1 or the EudraGMP database; 在附件2中列出附录1或EudraGMP数据库中没有提及的工厂目前生产的产品类型; - Listof GMP inspections of the site within the last 5 years; including dates andname/country of the Competent Authorities having performed the inspection. Acopy of current GMP certificate (Appendix 3) or reference to the EudraGMPdatabase should be included, if available. 近5年工厂接受GMP检查情况，包括检查时间和实施检查的监管机构名称及国家。如果有，请在附件3中提供当前的GMP证书的复印件或参考EudraGMP数据库。 1.3 Anyother manufacturing activities carried out on the site 工厂目前进行的其它生产活动 - Descriptionof non-pharmaceutical activities on-site, if any. 如工厂有非药品生产活动，请说明。 2. QualityManagement System of the Manufacturer 生产企业质量管理体系 2.1 Thequality management system of the manufacturer 生产企业质量管理体系 - Briefdescription of the quality management systems run by the company and referenceto the standards used; 简要描述公司质量管理体系运行情况以及参考的标准； - Responsibilitiesrelated to the maintaining of quality system including senior management; 包括高级管理层在内的质量体系相关职责，。 - Informationof activities for which the site is accredited and certified, including datesand contents of accreditations, names of accrediting bodies. 工厂质量体系获得认证认可的情况，包括认证认可日期、认可内容、认可机构名称等。 2.2 Releaseprocedure of finished products 成品放行程序 - Detaileddescription of qualification requirements (education and work experience) ofthe Authorised Person(s)/ Qualified Person(s) responsible for batchcertification and releasing procedures; 详细描述负责批确认与放行程序的授权人的资质要求; - Generaldescription of batch certification and releasing procedure; 概述批确认与放行程序； - Roleof Authorised Person/ Qualified Person in quarantine and release of finishedproducts and in assessment of compliance with the Marketing Authorisation; 授权人/产品放行人在待验与放行以及上市许可一致性评估中的职责； - Thearrangements between Authorised Persons/ Qualified Persons when severalAuthorised Persons/ Qualified Persons are involved; 当涉及多名授权人时的工作安排； - Statementon whether the control strategy employes Process Analytical Technology (PAT)and/or Real Time Release or Parametric Release. 请说明是否应用过程分析技术（PAT）及实时或参数放行产品。 2.3 Managementof suppliers and contractors 供应商和合同商的管理 - Abrief summary of the establishment/knowledge of supply chain and the externalaudit program; 简述公司供应链以及外部审计项目等情况； - Briefdescription of the qualification system of contractors, manufacturers of activepharmaceutical ingredients (API) and other critical materials suppliers; 简述合同商、原料药生产企业及其他关键物料供应商的资质确认系统； - Measurestaken to ensure that products manufactured are compliant with TSE(Transmittinganimal spongiform encephalopathy)guidelines. 采取哪些措施确保生产品种符合TSE （动物传染脑海绵状病）指南要求。 - Measuresadopted where counterfeit/falsified products, bulk products(i.e.unpackedtablets), active pharmaceutical ingredients or excipients are suspected oridentified. 对假药以及原辅料等造假风险较高的地区，采取哪些措施予以控制。 - Use ofoutside scientific, analytical or other technical assistance in relation tomanufacture and analysis; 委托生产和委托检验及其它项目委托情况 - Listof contract manufacturers and laboratories including the addresses and contactinformation and flow charts of supply-chains for outsourced manufacturing andQuality Control activities; e.g. sterilization of primary packaging materialfor aseptic processes, testing of starting raw materials etc, should bepresented in Appendix 4; 合同生产企业和实验室名单，包括以下信息：地址、联系方式、委托生产和质量检验活动的供应链流程图；例如：无菌工艺产品所用内包装材料灭菌、起始物料的检验等均应在附录4中予以表述清楚； - Briefoverview of the responsibility sharing between the contract giver and acceptorwith respect to compliance with the Marketing Authorisation (where not includedunder 2.2). 简述委托方和受托方在产品放行中的责任（不包括在2.2中）。 2.4 QualityRisk Management (QRM) 质量风险管理（QRM） - Briefdescription of QRM methodologies used by the manufacturer; 简述企业质量风险管理方法 - Scopeand focus of QRM including brief description of any activities which areperformed at corporate level, and those which are performed locally. Anyapplication of the QRM system to assess continuity of supply should bementioned. 按公司不同层级（集团和生产厂）简述质量风险管理的范围和重点，包应提及任何评估供应持续性的质量风险管理体系应用。 3. Personnel 人员 - Organisationchart showing the arrangements for quality management, production and qualitycontrol positions/titles in Appendix 5, including senior management andAuthorised Person(s) / Qualified Person(s); 企业质量管理、生产和质量控制及其负责人的组织机构图，包括高级管理层和授权人等（附件5）； - Numberof 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、储存及分销的员工数量。 4. Premises and Equipment 厂房和设备 4.1 Premises 厂房 - Short description of plant; size of the site andlist of buildings. If the production for different markets, i.e. for local, EU,USA, etc. takes place indifferent buildings on the site, the buildings should be listed with destinedmarkets identified (if not identified under 1.1); 简述生产工厂情况，包括场地面积和各建筑物名称等，如不同建筑物生产的品种面向当地以及欧盟、美国等不同市场，应在特定市场的建筑物上注明（如未在1.1明确） - Simpleplan or description of manufacturing areas with indication of scale(architectural or engineering drawings are not required); Lay outs and flowcharts of the production areas (in Appendix 6) showing the room classificationand pressure differentials between adjoining areas and indicating theproduction activities (i.e.compounding, filling, storage, packaging, etc.) inthe rooms; 简述生产区域规模情况，附厂区总平面布局图、生产区域的平面布局图和流向图，标明比例（不需要建筑或工程图纸）。应当标注出房间的洁净级别、相邻房间的压差，并且能指示房间所进行的生产活动（例如：配料、灌装、储存、包装等）（附件6）； Lay-outs of warehouses andstorage areas, with special areas for the storage and handling of highly toxic,hazardous and sensitising materials indicated, if applicable; 仓库和储存区域的平面图，如果有，包括储存和处理高毒性、危险性与敏感物料的特殊区域。 - Briefdescription of specific storage conditions if applicable, but not indicated onthe lay-outs. 如有，请简述特殊储存条件情况，但不需在平面图上注明。 4.1.1 Briefdescription of heating, ventilation and air conditioning (HVAC) systems 简述空调净化（HVAC）系统 - Principlesfor defining the air supply, temperature, humidity, pressure differentials and air change rates, policy of airrecirculation (%). 简述空调净化系统设计原则，如送风、温度、湿度、压力差以及换气次数、回风等 (%)。 4.1.2 Briefdescription of water systems 简要描述水系统 - Qualityreferences of water produced; 水质设计标准 - Schematicdrawings of the systems in Appendix 7. 水系统示意图附录7 4.1.3. Brief description of other relevant utilities,such as steam, compressed air, nitrogen,etc. 简要描述其它相关公用设施，例如蒸汽、压缩空气、氮气等系统。 4.2 Equipment 设备 4.2.1 Listingof major production and control laboratory equipment with critical pieces of equipmentidentified should be provided in Appendix 8. 列出生产和检验用主要仪器、设备附录8。 4.2.2 Cleaningand sanitation 清洁与消毒 - Brief description of cleaning and sanitationmethods of product contact surfaces(i.e. manual cleaning, automatic Clean-in-Place, etc). 简述与药品直接接触设备、工器具的表面清洗、消毒方法及验证情况（例如：人工清洁、自动在线清洁等）。 4.2.3 GMPcritical computerised systems 与药品生产质量相关的关键计算机化系统 - Description of GMP critical computerised systems (excluding equipment specific Programmable Logic Controllers (PLCs)). 简述与药品生产质量相关的关键的计算机化系统情况（不包括逻辑编程器（PLCs））。 5. Documentation 文件 - Descriptionof documentation system (i.e. electronic, manual); 描述企业的文件系统（例如电子、纸质）； - Whendocuments and records are stored or archived off-site (includingpharmacovigilance data, when applicable): List of types of documents/records;Name and address of storage site and an estimate of time required retrievingdocuments from the off-site archive. 如文件和记录在生产工厂外保存（如有，包括药物警戒数据），请提供外存的文件/记录目录、储存场所的名称和地址以及从厂区外取回文件所需的时间。 6. Production 生产 6.1 Type of products 产品类型 (references to Appendix 1or 2 can be made): （可参考附件1或2）： - Typeof products manufactured including 生产品种类型 ▪ list of dosage forms of both human and veterinaryproducts which are manufactured on the site 工厂生产剂型一览表（包括人用与兽用产品） ▪ list of dosage forms ofinvestigational medicinal products (IMP) manufactured for any clinical trials on the site, and when differentfrom thecommercial manufacturing, information of production areas and personnel 工厂生产临床试验用药品（IMP）剂型一览表，如生产场所与上市生产品种不同，请提供生产区域和生产人员信息。 - Toxicor hazardous substances handled (e.g. with high pharmacological activity and/orwith sensitising properties); 毒性或危险物质的处理情况（如高活性和/或高致敏药品）； - Producttypes manufactured in a dedicated facility or on a campaign basis, ifapplicable; 如有，请说明专用设备或阶段生产制造产品情况； - ProcessAnalytical Technology (PAT) applications, if applicable: general statement ofthe relevant technology, and associated computerised systems. 如有，请说明过程分析技术（PAT）应用情况，并概述相关技术和计算机化系统应用情况。 6.2 Process validation 工艺验证 - Briefdescription of general policy for process validation; 简要描述工艺验证的原则； - Policyfor reprocessing or reworking. 返工或重新加工的原则。 6.3 Material management and warehousing 物料管理和仓储 - Arrangementsfor the handling of starting materials, packaging materials, bulk and finishedproducts including sampling, quarantine, release and storage; 起始物料、包装材料、半成品与成品的处理，包括取样、待检、放行与储存； - Arrangementsfor the handling of rejected materials and products. 不合格物料和产品的处理 7. QualityControl (QC) 质量控制 - Descriptionof the Quality Control activities carried out on the site in terms of physical,chemical, and microbiological and biological testing. 描述理化检验、微生物及生物学检验等质量控制活动。 8. Distribution, Complaints, Product Defects andRecalls 分销、投诉、产品缺陷与召回 8.1 Distribution(to the part under theresponsibility of the manufacturer) 分销（属于制造商职责内的部分） - Types(wholesale licence holders, manufacturing licence holders, etc) and locations(EU/EEA, USA, etc.) of the companies to which the products are shipped from thesite; 分销商类型（包括是否持有经营许可证或制造许可证等）及其所在地区（欧盟/欧洲经济区、美国等）； - Descriptionof the system used to verify that each customer / recipient is legally entitled to receive medicinal products fromthe manufacturer; 描述用来确认顾客/接受者的系统，以证明顾客有合法资格接收药品； - Briefdescription of the system to ensure appropriate environmental conditions during transit, e.g. temperature monitoring/ control; 简要描述产品在运输过程中确保其符合贮存条件要求的的措施，例如： 温度监测/监控； - Arrangementsfor product distribution and methods by which product traceabilityis maintained; - 产品分销管理以及确保其可追踪的方法。 -Measures taken toprevent manufacturers’ products to fall in the illegal supplychain 防止产品流入非法供应链的措施。 8.2 Complaints,product defects and recalls 投诉、产品缺陷与召回 - Briefdescription of the system for handling complains, product defects and recalls. 简要描述投诉处理、产品缺陷与召回系统。 9. Self Inspections 自检 - Shortdescription of the self inspection system with focus on criteria used forselection of the areas to be covered during planned inspections, practicalarrangements and follow-up activities. 简要描述企业自检系统，重点说明自检计划中涉及范围的选择标准、自检实施以及整改情况。 相关附件： Appendix 1 Copy of valid manufacturing authorisation 附件1 有效的制造许可文件复印件 Appendix 2 List of dosage forms manufactured including the INN-names or common name (as available) of active pharmaceutical ingredients (API) used 附件2 所有生产剂型目录，包括所用原料药的INN名称或通用名（如有） Appendix 3 Copy of valid GMP Certificate 附件3 有效的GMP证书复印件 Appendix 4 List of contract manufacturers and laboratories including the addresses and contact information, and flow-charts of the supply chains for these outsourced activities 附件4 合同生产企业和实验室情况一览表，包括地址和联系信息以及外包活动的供应链流程图。 Appendix 5 Organisational charts 附件5 组织机构图 Appendix 6 Layouts of production areas including material and personnel flows, general flow charts of manufacturing processes of each product type (dosage form) 附件6 生产区域平面图，包括物料和人员流向图，各类型（剂型）产品 生产工艺流程图 Appendix 7 Schematic drawings of water systems 附件7 水系统示意图 Appendix 8 List of major production and laboratory equipment 附件8 关键生产设备与实验室设备、仪器清单
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发表于 2016-1-7 11:58:56
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