GMP实施阶段需要注意什么内容?

2023-02-28 · 法默康

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GMP实施阶段需要注意什么内容?封面图

正文内容

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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