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1、GMP初次培训:讲述GMP基础知识及企业实施GMP的意义;
1. Initial GMP training: describe the basic knowledge of GMP and the significance of implementing GMP in enterprises;
2、协助企业进行硬件改造:为企业提供规范可行的硬件改造意见;
2. Assist enterprises in hardware transformation: provide normative and feasible hardware transformation suggestions for enterprises;
3、监督检查改造过程及对改造效果的评价;
3. Supervise and inspect the transformation process and evaluate the transformation effect;
4、GMP软件体系建立、实施磨合;
4. GMP software system establishment and implementation running-in;
5、GMP文件编写(内容、格式)培训;
5. GMP document preparation (content and format) training;
6、GMP文件初稿审核、修改;
6. Review and revision of the first draft of GMP documents;
7、监督、检查GMP文件在实际工作中运行情况,并调整、改进,再运行磨合;
7. Supervise and check the operation of GMP documents in actual work, adjust and improve them, and then run in;
8、企业拟订内审计划、方案;
8. The enterprise formulates internal audit plans and plans;
9、参与内审过程,针对发现的问题提出改进措施;
9. Participate in the internal audit process and propose improvement measures for the problems found;
10、通过改进来完善GMP体系。
10. Improve the GMP system through improvement.
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