Qualification protocol of Compressed air
system
压缩空气系统确认方案
Prepared by起草： Date日期：
Reviewed by审阅： Date日期：
Approved by批准： Date日期：
Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 2 页
Table of contents 目 录
1.0 Instruction引言 ................................................................................. 3 1.1 Summarize概述 ............................................................................ 3 1.2 State of Equipment设备的基本情况 ............................................... 3 2.0 Purpose验证目的 .............................................................................. 4 3.0 Responsibility验证职责 .................................................................... 4 3.1 Validation team验证小组 ............................................................... 4 3.2 Equipment department设备部 ....................................................... 5 3.3 Quality department质量部 ............................................................. 5 4.0 Validation scope验证范围 ................................................................ 6 5.0 Validation content验证内容 .............................................................. 6 5.1 Installation Qualification(IQ)安装确认 ............................................. 6 5.2 Operation Qualification(OQ)运行确认 ............................................ 9 5.3 Performance Qualification性能确认 ............................................ 10 5.4 Re-validation and re-validation period拟定再验证及验证周期 ..... 11 5.5 Conclusion 验证方案结论 ............................................................ 12 6.0 Approval of validation protocol验证方案最终批准 ........................ 12
Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 3 页
Content正文
1.0 Instruction引言：
1.1 Summarize概述：Compressed air met Criteria was provided for manufacturing process produced from air compressor in this Compressed air system and cleaning treated. 本压缩空气处理系统是通过空压机制取的压缩空气，经过净化处理后为生产工艺提供合格的洁净空气。
System process 系统流程：
Air→Air compressor→Compressed air→Compressed air tank→pre-filter(Class C) →Refrigeration Air Dryer→Filter(Class T) →Filter(Class A) →Filter(Class H) →Cleaning air.
空气→空压机→压缩空气→贮气罐→前置过滤器（C级）→冷冻式干燥机→空气过滤器（T级）→空气过滤器（A级）→空气过滤器（H级）→洁净空气。
1.2 State of Equipment设备的基本情况：
Item项目 No编号 Name名称 Model型号 Series系列号 Manufacturer 生产厂家 release date 出厂日期 Contact联系人 Arrival date 到货日期 Owner Department 使用部门 Position 放置地点 Owner 管理员 Air compressor 空压机 Tank of compressed air 贮气罐 Refrigeration Air Dryer 冷冻式干燥机 Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 4 页
Services name 服务单位名称 Services address服务单位地址 Tel联系电话 Checked by检查人： Reviewed by复核人： Date检查日期： Date复核日期： 2.0 Purpose验证目的：
2.1 Checking the air compressed system and ensure the qualification of installation、operation、 performance to meet designed criteria 检查并确认该压缩空气处理系统安装、运行、性能等各项技术指标符合设计要求。
2.2 Ensure the archive of relatively data and file to meet the requirement of GMP. 确保相关资料和文件的存档管理符合GMP要求。
2.3 Inspect compressed air if it's meet the requirement of manufacture.检查处理后的压缩空气是否达到生产要求。
3.0 Responsibility验证职责：
3.1 Validation team验证小组：
3.1.1 Responsible for approval of protocol负责验证方案审批。
3.1.2 Responsible to coordinate the work of validation, ensure the implement of this protocol effectively.负责验证的协调工作以保证本验证方案规定项目的顺利实施。
3.1.3 Responsible for approval of validation report.负责验证报告的审批。 3.1.4 Responsible for signing and issue the certification of validation负责验证证书的发放。
3.1.5 Responsible for affirmed the period of validation负责验证周期的确认。
Qualification protocol of Compressed air system压缩空气系统验证方案 共 12 页 第 5 页
3.2 Equipment department设备部：
3.2.1 Responsible for draft the protocl负责验证方案的起草。
3.2.2 Responsible for installing,adjusting the equipment and recording.负责设备的安装、调试并作好相应记录。
3.2.3 Responsible for the calibration of equipment and meter.负责仪器仪表的校正。
3.2.4 Responsible for collected all validation data and submit to the validation team. 负责收集各项验证记录，报验证小组。
3.2.5 If this protocol need to change because of specific cause, Equipment department should be responsible to fill 'the application and approval form of protocol change.若因特殊原因需变更原验证方案时，应负责填写“验证方案变更申请及批准书”，报验证小组批准。
3.2.6 Responsible for providing mainly parameter of equipment.负责提供与设备有关的主要参数。
3.2.7 Responsible for operation、cleaning and maintenance of equipment.负责设备的操作、清洗和维护保养。
3.2.8 Responsible for implement of this protocol.负责验证方案的实施。 3.2.9 Responsible for identified the re-validation period and protocol.负责拟定再验证方案及周期。
3.3 Quality department质量部：
3.3.1 The representative of Quality department should be involved in the approval of validation protocol and report.质量部负责人参与验证方案、验证报告的审阅。