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1、药检所Document No.编码:URS-无菌隔离系统用户需求说明书 Page 1 of 13用户需求说明书User Requirement Specification无菌隔离系统Sterility Isolator System药检所Document No.编码:URS-无菌隔离系统用户需求说明书 Page 2 of 13Prepared by 起草Name 姓名Signature 签字Date 日期Reviewed by 审核Name 姓名Signature 签字Date 日期Approved by 批准Name 姓名Signature 签字Date 日期Richard. Clarke药
2、检所Document No.编码:URS-无菌隔离系统用户需求说明书 Page 3 of 13修订历史纪录Revision HistoryRevision版本Revision Date修订日期Reason for Revision/Change Request修订/更改要求的原因Revised By修订人药检所Document No.编码:URS-无菌隔离系统用户需求说明书 Page 4 of 13目 录1. 总则 GENERAL PRINCIPLES .52. 适用的法规和指南 Applicable Regulations and Codes Referred .53. 缩写和定义 ABBR
3、EVIATION AND DEFINITION.64.设备系统描述 EQUIPMENT SYSTEM DESCRIPTIONS.65Equipment system technical requirement 设备系统技术要求 .76.文件和培训 DOCUMENTATION AND TRAINNING REQUIREMENTS .117. ASSUMPTION 参考条件 .138. INTERFACES 相关系统 .139. ATTACHED DRAWINGS 附图 .13药检所Document No.编码:URS-无菌隔离系统用户需求说明书 Page 5 of 131. 总则 GENERAL
4、 PRINCIPLES1.1 This URS will be applicable for purchase of sterility isolator system in SIFDC. Design, manufacturing and performance of the machine shall be state-of-the-art, in compliance of GMP requirements of China, EU and US FDA.本用户需求书所列技术要求适用于上海荣盛生物药业有限公司无菌隔离器系统,设备在设计、制造技术及性能上达到国际先进水平,符合中国、欧盟和
5、FDA 的 GMP 要求。1.2 This URS describes basic requirements on the machine, including: performance, critical technical parameters, safety, installation and compliance with GMP requirements of China, EU and US FDA. This URS will also be taken in account during the following qualifications and validations
6、activities, including IQ/OQ/PQ protocol and report.本 URS 描述了该仪器的基本需求,包括:工作性能需求、关键技术参数要求、安全要求、符合中国、欧盟和 FDA 的 GMP 要求和安装及其他要求。同时,这份用户要求文件也是开展后续相关验证工作的基础,包括: IQ 草案和报告、OQ 草案和报告、PQ草案和报告。1.3 Basic requirements in this URS doesnt cover or restrict better design, higher standard, better function, configurati
7、on, performance, components and control system of Sellers machines. Sellers machines should comply with regulations of design, manufacturing, safety, environment protection and compulsory standards in China. In case of conflicts between Sellers standards and Chinese regulations, the stricter one wil
8、l prevail (not applicable to compulsory standard).在本 URS 中用户仅提出基本的技术要求和设备的基本要求,并未涵盖和限制卖方设备具有更高的设计与制造标准和更加完善的功能、更完善的配置和性能、更优异的部件和更高水平的控制系统。投标方应在满足本 URS 的前提下提供卖方能够达到的更高标准和功能的高质量设备及其相关服务。卖方的设备应满足中国有关设计、制造、安全、环保等规程、规范和强制性标准要求。如遇与卖方所执行的标准发生矛盾时,应按较高标准执行(强制性标准除外) 。2. 适用的法规和指南 Applicable Regulations and Cod
9、es Referred以下为在本用户需求标准 URS 中所参考的文献标准:1. EN 292 1 & 2 Safety of Machinery Basic Concepts, General Principles for Design.EN 292 1 & 2 机械安全-基本概念,设计的一般理论药检所Document No.编码:URS-无菌隔离系统用户需求说明书 Page 6 of 132. EN 60204-1 Safety of Machinery - Electrical Equipment of Machinery.EN 60204-1 机械安全-机械电气设备3. ASME Cod
10、e. ASME 法规4. GAMP 4 Good Automated Manufacturing Practice Guide for Validation of Automated Systems in Pharmaceutical Manufacture 生产自动化管理规范第 4 版 5. cGMP Current Good Manufacturing Practice Guide of Automated Systems in Pharmaceutical Manufacture. 现行药品生产质量管理规范6. GEP Good Engineering Practice. 良好工程管理规
11、范7. 21CFR Part 11 Electronic Records; Electronic Signatures, 电子记录;电子签名8. GMP requirement of China.中国:药品生产质量管理规范9. GMP requirement of EU. 欧盟:药品生产质量管理规范10. Chinese pharmacopeia. 中国药典11. US pharmacopeia. 美国药典12. EU Pharmacopeia. 欧洲药典3. 缩写和定义 ABBREVIATION AND DEFINITIONName缩写Description注释I/O Input / Out
12、put. 输入/输出IQ Installation Qualification 安装确认OQ Operation Qualification 运行确认PQ Performance Qualification 性能确认SOP Standard Operation Procedure 标准操作规程URS User Requirements Specification. 用户需求标准4.设备系统描述 EQUIPMENT SYSTEM DESCRIPTIONS4.1 基本描述 General Descriptions 无菌隔离系统主要用于产品的无菌测试,能够有效地降低或消除无菌测试的假阳性风险,保证无
13、菌检验操作环境及检验结果的准确性、真实性。相比传统无菌洁净室,隔离系统能够避免人员在内活动,因此不存在人员潜在的微生药检所Document No.编码:URS-无菌隔离系统用户需求说明书 Page 7 of 13物污染风险。采用传递隔离器代替传统的传递窗,实现物品的表面杀菌处理。避免在物料传递时引起的污染。4.2 Scope of supply 供货范围1)QIS-1800S 型 4 手套操作口实验舱,主操作面 2 操作口,次操作面 2 操作口 1 台;2)QIS-V102 型过氧化氢灭菌器 1 台;3)QIS-600 型内置式集菌仪(ISOLATOR 专用型号) 1 台;5Equipment
14、 system technical requirement 设备系统技术要求For each requirement specification, suppliers should answer Yes or No at the remarks column to indicate the satisfactory level of provided equipment. Suppliers may offer more advanced and reliable measures if the equipment did not meet the requirement. Please provide the details in w