无菌检查隔离系统SZ1806BURS.doc

用户需求说明书 User Requirement Specification 无菌隔离系统 Sterility Isolator System  Prepared 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  修订历史纪录 Revision History Revision 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  目录 1. 总则general Principles 5 2. 适用的法规和指南Applicable Regulations and Codes Referred 5 3. 缩写和定义Abbreviation and Definition 6 4.设备系统描述Equipment System Descriptions 6 5．Equipment system technical requirement设备系统技术要求 7 6.文件和培训Documentation and trainning Requirements 11 7. Assumption参考条件 13 8. Interfaces相关系统 13 9. Attached Drawings附图 13 1. 总则general Principles 1.1 This URS will be applicable for purchase of sterility isolator system in ALKPHARM. 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浙江昂立康制药有限公司无菌隔离系统的采购。新的设备在设计、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 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 doesn’t cover or restrict better design, higher standard, better function, configuration, performance, components and control system of Seller’s machines. Seller’s machines should comply with regulations of design, manufacturing, safety, environment protection and compulsory standards in China. In case of conflicts between Seller’s standards and Chinese regulations, the stricter one will prevail (not applica