1、日期Author起草人Reviewed by审核人Approved by批准人Document History:文件历史：Revision版本作者Description描述002009.09.20First vesion01Table of Contents:目录：1. Introduction 介绍32. Overview 总览32.1. Scope 范围32.2. System Description 系统描述02.3. Organization and Responsibilities 组织和责任23. References 参考34. Definitions 术语45. Protoco
2、l Addenda 方案附录66. Documentation 文档编制66.1. Data and Results 数据和结果66.2. Deviations 偏差66.3. Executors Signature List 执行者签名列表77. Corrective Action Form 纠偏表88. Materials and Equipment 物料和设备109. Performance Qualification Procedure 性能验证程序119.1. Verification of Standard Operating Procedures 标准操作程序验证119.2. O
3、perations of the Particle Monitoring System 粒子监测系统的操作119.3. General Performance 总体性能1110. Performance Qualification Test Scripts 性能验证测试脚本1210.1. Verification of Standard Operating Procedures 标准操作程序验证1210.2. Operations of the Particle Monitoring Systems 粒子监测系统的操作1410.3. General Performance 总体性能1911.
4、Appendix of Data Sheets 数据表附录2111.1. Preparation for Sampling Data Sheet 采样准备数据表2211.2. Sampling Data Sheet 采样数据表2511.3. Alarming Data Sheet 报警数据表2811.4. Report Generation Data Sheet 报告生成数据表3111.5. Backup activities Data Sheet 备份活动数据表3411.6. System Maintenance Data Sheet 系统维护数据表3711.7. Performance D
5、ata Sheet 性能数据表401. Introduction 介绍This Performance Qualification was prepared by XXX, Inc. to provide documented evidence that the XXX System in XXX Pharmaceutical Co., Ltd XXX Production Zone operates in accordance with approved procedures during the normal operation of the monitored process.性能验证文
6、件是由 XXX 准备，用于证明 XXXX 制药有限公司 XX 生产区的粒子监测系统在被监测生产过程的正常运转期间的运行符合被核准的流程。2. Overview 总览2.1. Scope 范围This scope of this protocol is limited to the verification of performance requirements as specified in approved operating procedures for the system as outlined in the table below.此文件范围仅限于按照被批准的操作程序来运行系统的性能
7、验证需求，如下表所列：Table 1: Procedural RequirementsProcedure程序Requirements要求Operation of the Particle Monitoring System粒子监测系统操作System Startup系统启动Preparation for Sampling采样准备Sampling采样Alarm Generation and Response警报产生及响应Report Generation报告产生Backup, Restore and Disaster Recovery备份、还原和灾难恢复Daily Database Backup
8、每日数据库备份Configuration Backup配置备份Database and Configuration Restoration数据库和还原Disaster Recovery灾难恢复System Maintenance系统维护Pump Maintenance真空泵维护Particle Sensor Maintenance粒子传感器维护Computer Maintenance计算机维护表 1：程序要求2.2. System Description 系统描述2.2.1. The Particle Monitoring System has been designed to provide
9、 real-time and historical information to equipment operators, managers and quality personnel with regard to actual particle count that may affect sterile processes within the production environment and other background environments which support production and other critical processes.粒子监测系统是为了向设备操作
10、者、管理者和质量控制人员提供可能影响到关键过程的实际的粒子数量级别的实时及历史信息而设计的。2.2.2. The Particle Monitoring System provides real time monitoring to via Pharmaceutical Net software and external alarming devices to achieve the appropriate awareness.粒子监测系统使用粒子计数器（又叫粒子传感器），实时监测软件，和外部报警设备（报警塔）来实现相应的功能。2.2.3. Particle Monitoring粒子监测2.2
11、.3.1. The Airnet II particle counter utilizes an external vacuum source to maintain a constant flow rate of 1 CFM （cubic foot per minute） of air through a focused laser beam in the sample chamber. As particles pass through and obstruct the beam, light is scattered and focused by a set of parabolic m
12、irrors onto a photo- detector which registers the magnitude of light and categorizes the particle as either fitting within the 0.5m or 5.0m particle channels.Airnet II 粒子传感器利用外部真空源维持 1CFM（28.3 升/分钟）的空气采样流量，通过在采样腔体中的激光束。当粒子穿过并遇到激光束时，光线就会被散射并由一套抛物柱面的反射镜聚集到光电探测器上，光电探测器记录光线的大小数量并将通过的粒子归类到 0.5m 或 5.0m 的粒
13、子通道。2.2.3.2. Power to the Airnet II particle counters is provided by a central DC power supply installed in the system control panel.Airnet II 粒子传感器由安装在系统控制柜中的中央直流电源供电。2.2.3.3. Real-time particle count data is transferred from the Airnet II particle counters to a computer （hereafter Real Time Statio
14、n） running Pharmaceutical Net Real Time Station software.实时粒子计数数据由粒子传感器传送到一个运行 Pharmaceutical Net 实时监测站软件计算机上（后面称为实时监测站）。2.2.3.4. The Real Time Station compares data from the Airnet II particle counters against hardware, system and data limits defined in the software, and provides status notificatio
15、n.实时监测站对比从粒子传感器得来的数据和软件所设定的数据，并给出状态报告。2.2.3.5. Hardware and system limits are hard-coded in the software, and include flow errors, laser errors, communication errors and database errors.硬件和系统的极限被硬编码在软件中，包括流量错误，激光错误，通信错误和数据库错误。2.2.3.6. Pump and sensor power are controlled by the operator。真空泵及传感器的电源有操
16、作人员控制。2.2.4. Enode I/O ControllerEnode 输入/输出控制器2.2.4.1. ENODE is a proprietary, modular I/O management device designed in this system to provide an interface between the RTS and relay outputs to the alarm station.ENODE 是一个专利，是模块化的 I/O 管理设备，在本系统中作为 RTS 和报警站继电输出之间的接口。2.2.4.2. The ENODE is completely c
17、ontrolled by Pharmaceutical Net software and does not require configuration of ladder logic.ENODE 完全由 Pharmaceutical Net 软件控制，不需要梯形图逻辑编程。2.2.4.3. Input and Output configuration for the ENODE is required and can be found in the Hardware Design Specification.ENODE 在使用前需进行输入输出配置，这在硬件设置说明文件中描述。2.2.5. Ad
18、ditional Functionality 附加功能2.2.5.1. Alarm and warning limits are configurable for all sample points. Up to four levels （0 3） of alarming are available, as well as the ability to designate the individual levels as warnings or alarms. This system uses levels 1 for warnings and levels 2 and 3 for alarm
19、s.所有采样点均设有警报及警告极限。报警设置有 4 个级别（03），可分别被设为警告或者警报。此系统中，级别 1 为警告，级别 2 和 3 为警报。2.2.5.2. Data which falls outside of specified limits is reported on screen （along with a color indication）, in the Event Log （along with date, time, user logged on, and detailed description of the alarm）, and as an external a
20、larm notification to the alarm tower module.若数据超出设定极限，在现实屏幕上会有报告（有颜色区分），产生时间记录（包含日期、时间、登录用户和报警描述），外部警报设备警报塔会发出提示。2.2.5.3. The Alarm Tower is managed by the ENODE Relay Output module which is configured in this system to output a 24 volt signal to the green lamp module when there are no warnings or a
21、larms, the yellow lamp module when there are warnings, and simultaneously to the red lamp and audible alarm modules when there are alarms. Alarm outputs are exclusive, such that only the highest priority alarm status is reported at the alarm tower （Alarms have a higher priority than warnings）.警报塔由 E
22、node 继电输出模块管理控制。当系统无任何警告或者警报时绿灯获得 24V 输出信号；当系统有警告时，黄灯获得 24V 输出信号；当系统有警报时，红灯和声音警报同时获得 24V 信号。警报输出是高一级别的。警报塔输出最高优先级的报警（警报优先级高于警告）2.2.5.4. When pressed, a momentary push-button （hereafter Alarm Reset Button） latches a relay in the system control panel to silence the audible portion of the alarm.当按下复位按钮
23、，控制箱内的继电器会被触动，使声音警报消除。2.3. Organization and Responsibilities 组织和责任The validation team consists of the members defined in the Quality Plan document.验证小组包含 QP 文件中所定义的参与人员。3. References 参考 Guidance for Industry Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice, US
24、 department of Health and Human Services, Food and Drug Administration, September 2004. 行业规范 - 无菌处理生产的无菌药品产品 - 现行药品生产质量管理规范，美国卫生与公众服务部，食品药品管理局，2004 年 9 月。 All documentation developed as a result of the implementation of this project will comply with the following GMP regulatory requirements and/or r
25、ecommendations: 本项目执行所产生的所有文件均遵循如下 GMP 规范的要求和/或建议：o 21 CFR, Part 210, Current Good Manufacturing Practice in the Manufacturing, Processing, Packing or Holding of Drugs; General.o 21CFR,Part211,CurrentGoodManufacturingPracticeforFinished Pharmaceuticals.o 21 CFR, Part 11 Electronic Records; Electroni
26、c Signatures.o FDA, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002.o FDA, Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices, September 9, 1999.o ISO 9001:2000, Quality Systems Model for quality
27、 assurance in design, development, production, installation and servicing.o ISPE/GAMP Forum, Good Automated Manufacturing Practices （GAMP） Version 4, 2001.o Food and Drug Administration, Guidance for Industry: Part 11, Electronic Records; Electronic Signatures Scope and Application （August 2003）.o E
28、C Guidance on Manufacture of Pharmaceuticals Annex 1.（Manufacture of Sterile Medicinal Products） 2008.4. Definitions 术语 BLOb Binary Large Object 二进制大型对象 BSD Berkeley Software Distribution 伯克利软件分布 C/CF Counts per Cubic Foot 每立方尺计数 C/M3 Counts per Cubic Meter 每立方米计数 CFM Cubic Foot per Minute （usually
29、airflow） 每分钟立方尺 CFR Code of Federal Regulations 美国联邦法规 cGMP current Good Manufacturing Practices 现行药品生产质量管理规范 CSV Comma Separated Variable 逗号分隔值 DC Direct Current 直流电 DCP Data Collection Point （sample point） 数据收集点（采样点） DLL Dynamic Link Library 动态链接库 EC European Commission 欧盟委员会 Encrypted Database electronic file storage system that is considered unalterable by the end user 不得由终端用户变更的电子文档存贮器 EMS Environmental Monitoring System 环境监测系统 ENODE PMS Device I/O Management PMS 输入输出管理设备 FDA US Food and Drug Administration 美国食品药品管理局 FS
