动物饮用水无菌验证.docx

编号No.：PQP-15XX-1.0 性能确认Performance Qualification起草于2015年04月Prepared April 2015 名称Title动物饮用水无菌确认Microbial level qualification of laboratory animal drinking water房间号Room NoNA验证的仪器、设备或程序Instrument/Equipment/Procedure to be Validated设备供应商Supplied by: NA设备序列号Equipment Register: NA设备编号Equipment NumberNA验证方案的批准Approval of the Validation Protocol审核和批准了相关SOP、标准和日程表之后在下表签字Sign here after reviewing and approving the SOPs, standards and schedules头衔Title姓名Name签名Signature日期Date起草人Written By:验证负责人VD王海洋Haiyang Wang批准人Approved By:主管Supervisor王海洋Haiyang WangQA负责人QA Manager刘振超Zhenchao Liu机构负责人Test facility manager夏玉叶Yuye Xia目录Table of Contents1通用说明和先决条件General Instructions and Prerequisite31.1目的Objective31.2设备描述Equipment Description31.3术语和定义32责任43文件和标准操作规程Documents and Standard Operating Procedures43.1完成本文件Completion of this Document43.2文件列表Qualification Documents44使用的仪器和标准品Test Instrumentation and Standards Used in the Qualification65性能确认Performance qualification66缺陷报告附件列表Deficiency Report Attachments List77批准Approvals87.1临时批准Interim Approval87.2最终批准Final Approval81 通用说明和先决条件General Instructions and Prerequisite1.1 目的Objective这份方案描述动物饮用水无菌的确认程序。This protocol will define the procedure to be followed for the Microbial level qualification of sterilized items in clean areas.1.2 方法描述Method Description1.2.1 未灭菌水：将SPF区域内的出水龙头用医用酒精擦拭后，打开水龙头，3 min后用灭过菌的饮水瓶取水，密闭备用。Unsterilized water: In SPF area, use medical alcohol to clean water tap first, then open the tap, after 3 minutes, collect water from the tap with a sterilized container, seal the container.1.2.2 灭菌水：按照1.2.1方法取水，取水后送到高压灭菌锅灭菌。Sterilized water: collect water according to the steps described in 1.2.1, then sterilize the water collected in the container in an autoclave.1.2.3 在超净工作台或生物安全柜内，取1 mL未灭菌水接种于营养肉汤培养基，然后将接种过的培养基放入生化培养箱培养。同样的方法取1 mL灭菌水接种于营养肉汤培养基，然后将接种过的培养基放入生化培养箱培养。In clean bench or biosafety cabinet, pipette 1 mL of unsterilized water into nutrient broth media, and then cultivate the inoculated nutrient broth media in a biochemical incubator. And so does the sterilized water.1.2.4 在超净工作台或生物安全柜内，取1 mL未灭菌水接种于营养琼脂培养基，然后将接种过的培养基放入生化培养箱培养。同样的方法取1 mL灭菌水接种于营养琼脂培养基，然后将接种过的培养基放入生化培养箱培养。In clean bench or biosafety cabinet, pipette 1 mL of unsterilized water into nutrient agar media, and then cultivate the inoculated nutrient agar media in a biochemical incubator. And so does the sterilized water.1.3 术语和定义关键缺陷-在关键缺陷项目被（解决）完成之前，验证工作不能签署通过。Critical Deficiency Validation may not be signed off until the item is closed out.非关键缺陷-验证工作可以签署通过，可是继续使用没有被缺陷影响的项目。NonCritical Deficiency Validation may be signed off and (continued) use of the item is not impacted by the deficiency.2 责任活动Activity责任方Responsible Party起草和批准方案Prepare and approve protocol苏州华测生物技术有限公司CTI BIOTECHNOLOGY (SUZHOU) Co., Ltd.协调验证活动Coordinate Validation Protocol Activities验证负责人VD-王海洋VD-Haiyang Wang提供使用仪器或设备的许可Provide access to itemNA提供服务支持许可Provide contractor support and accessNA安排测试（如果需要）Arrange laboratory testing (as required)验证负责人VD-王海洋VD-Haiyang Wang执行方案和起草报告Execute Protocol and prepare report验证负责人VD-王海洋VD-Haiyang Wang验证参与人员-李永超 Participant-Yongchao Li验证参与人员-王雨蒙 Participant-Yumeng Wang验证参与人员-姜英 Participant-Ying Jiang起草最终报告Prepare final report验证负责人VD-王海洋VD-Haiyang Wang批准最终报告Approve final report验证负责人VD-王海洋VD-Haiyang Wang机构负责人- 夏玉叶TFM-Yuye xia3 文件和标准操作规程Documents and Standard Operating Procedures3.1 完成本文件Completion of this Document本文件不可复制。所有数据都必须在原始文件或附加表格上完成。每份附加表格都必须签名和署日期。This document is not to be copied. All results must be completed on the original document or on supplementary records attached to this document. Each attachment must be signed and dated.本文件提供的空格都必须填写，如果不需要填写或者不适用，应当在相应空格里说明。如果某个数字或空格不需要，划对角线标明不适用，或填入NA。All spaces provided in the PQ document must be completed. If a result is not applicable or not required this should be stated in the space provided. If a number of spaces are not required, a diagonal line through all spaces with a Not Applicable sign may be used.本文件用黑色笔填写This document must be completed in black pen only.3.2 文件列表Qualification Documents需要以下文件以完成PQ The following documents are required for completion of the PQ文件Document文件号和/或文件名Document # and/or Title确认人Verified by:使用与维护规程Operation and maintenance SOPNA校验规程Calibration SOPNA培训记录Training RecordBTC-MAN-0305-1.2设备或仪器的使用日志Equipment /Instrument Log BooksBTC-EQU-0301-1.04 使用的仪器和标准品Test Instrumentation and Standards Used in the Qualification列举执行运行确认所需的仪器、标准品和其他物品。List of test instruments, reference standards and other materials required for the execution of the PQ. 仪器或标准品Instrumentor Standard序列号Serial No.证书编号Certificate No.计量日期Date Calibrated计量有效期至Calibration Due Date确认人Verified by:生化培养箱12070015NA脉动真空双扉灭菌柜20132261NANANA生物安全柜1374315030602NANANA超净工作台2013-82097NANANA数显恒温水浴锅0001289NANANA医用酒精批号：NANANA营养肉汤培养基批号：NANANA营养琼脂培养基批号：NANANA5 性能确认Performance qualification为系统关键参数的运行范围和可靠性提供可信根据。To provide confidence in the reliability and operating ranges critical operating variables of the system. 列举所要进行的测试List the tests to be completed here测试号Test #关键变量Critical Variable期望的运行范围Anticipated Operating Ranges责任分配Responsibility to Complete5.1未灭菌水无菌效果Microbial level of unsterilized water培养皿中无细菌生长No phenomenon of bacteria growth王雨蒙和姜英Yumeng Wang& Ying Jiang5.2灭菌水无菌效果Microbial level of sterilized water培养皿中无细菌生长No phenomenon of bacteria growth王雨蒙和姜英Yumeng Wang& Ying Jiang5.3未灭菌水培养后菌落数CFU of unsterilized water after cultivation0王雨蒙和姜英Yumeng Wang& Ying Jiang5.4灭菌水培养后菌落数CFU of sterilized water after cultivation0王雨蒙和姜英Yumeng Wang& Ying Jiang按照附件A的样式插入测试和结果记录表Insert test sheets and result formats per attachment A.6 缺陷报告附件列表Deficiency Report Attachments List一份显示安装确认过程中产生的缺陷报告和缺陷报告状态的列表。List deficiency reports produced during the Installation Qualification and their status. Refer to attached detailed reports. 缺陷报告号Deficiency Report #缺陷概要描述Deficiency Description Summary分类Classification完成Close out检查人Checked by日期Date关键Critical非关键Non Critical关键Critical非关键Non Critical关键Critical非关键Non Critical7 批准Approvals7.1 临时批准Interim Approval如果没有关键验证缺陷调查，就直接进行最终批准。如果有关键缺陷就暂停批准。如果有非关键缺陷存在就执行临时批准，但不能执行最终批准。If there are no outstanding Critical Validation Deficiency Investigations go to final approval. If there are critical deficiencies withhold approvals. If the deficiencies are non-critical provide interim approval but not