GMP高效包衣机使用和清洁规程

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1 Purpose/目的

To ensure that the high efficiency coating machine is operated correctly./确保高效包衣机的正确操作。

2 Scope/范围

本规程适用于包衣岗位的BG150F 高效包衣机的包衣操作。

3 Related management systems/体系相关性

3.1 Quality management system or GMP system ：Yes

与质量管理体系或GMP 体系的相关性：相关

3.2 Health and safety system ：Yes

与健康安全体系的相关性：相关

3.3 Environment control system ：Yes

与环境控制体系的相关性：相关

4 Responsibility/职责

4.1 It is the responsibility of the Production Manager to ensure that operators are trained

against this procedure

生产经理负责确保按本程序对操作人员进行培训。

4.2 It is the responsibility of persons trained against this procedure to ensure they always

follow it exactly

受训人员负责确保正确遵循本程序。

5 Contents/内容

5.1 检查及设备安装