Cleaning validation(CV) protocol 清洁验证方案

Cleaning validation(CV) protocol of

Mixing tank、Storage tank、Transfer vehicle and Pipeline 配液罐、储液罐、移液车及其管道清洁验证方案

Prepared by起草：Date日期：

Reviewed by审阅：Date日期：

Approved by批准：Date日期：

Table of contents

目录

1.0 Summarize概述 (3)

2.0 Purpose验证目的 (3)

3.0 Responsibility验证职责 (3)

3.1 Validation team验证小组 (3)

3.2 Production department生产部 (4)

3.3 Equipment department设备部 (4)

3.4 Quality department质量部 (5)

4.0 Validation scope验证范围 (5)

5.0 Validation content验证内容 (5)

5.1 Cleaning procedure清洗规程 (5)

5.2 Sample Plan取样计划 (5)

5.3 Test and Evaluation 测试和评估 (8)

5.4 Re-validation and re-validation period拟定再验证及验证周期 (9)

5.5 Conclusion 验证方案结论 (10)

6.0 Approval of validation protocol验证方案最终批准 (10)

1.0 Summarize概述: Mixing tank, storage tank, transfer vehicle and pipeline were used in alcohol wipe workshop for the 70% Isopropyl alcohol solution's storage and transporting. Because this system cleaning effect may affects the quality of the product, so we will perform a cleaning validation(CV) for this system. 配液罐、储液罐、移液车及其管道用于酒精擦片车间的药液配料、储存及药液运送，该系统的清洗效果直接影响到产品的质量，因此我们将对本系统进行一个清洁验证。

2.0 Purpose验证目的: Confirm cleaning procedure of mixing tank, storage tank, transfer vehicle and pipeline was reliability, to perform the cleaning procedure, right after a number of chemical pollution 确认配液罐、储液罐、移液车及其管道的清洗规程的可靠性，执行清洁程序后，不对后一批药液产生污染。

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。

3.2 Production department生产部：

3.2.1 Responsible for draft the protocol负责验证方案的起草。

3.2.2 Responsible for collected all validation data and submitted to the validation team. 负责收集各项验证记录，报验证小组。

3.2.3 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。

3.2.4 Responsible for operation、cleaning and maintenance of equipment.负责设备的操作、清洗和维护保养。

3.2.5 Responsible for implement of this protocol.负责验证方案的实施。

3.2.6 Responsible for identified the re-validation period and protocol.负责拟定再验证方案及周期。

3.3 Equipment department设备部：

3.3.1 Responsible for installing, adjusting the equipment and recording.负责设备的安装、调试并作好相应记录。

3.3.2 Responsible for the calibration of equipment and meter.负责仪器仪表的校正。

3.3.3 Responsible for providing mainly parameter of equipment.负责提供与设备有关的主要参数。

3.3.4 Responsible for assisting implement of this protocol.负责协助验证