德信诚培训网
更多免费资料下载请进： 好好学习社区 Standard Operation for the Coating Process
包衣工序基本操作规程
1 Purpose/目的
确保包衣过程正确地进行。

2 Scope/范围
本规程是关于素片的包薄膜衣或糖衣的生产过程。

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 ：N/A
与健康安全体系的相关性：不相关
3.3 Environment control system ：N/A
与环境控制体系的相关性：不相关
3.4 HACCP system ：N/A
与危害风险控制体系的相关性：不相关
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。