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GMP认证咨询方案主要分为五个阶段：
The GMP certification consultation program is mainly divided into five stages:
（一）初步阶段：调查诊断、协助企业合理调整、利用资源。
（1） Preliminary stage: investigate and diagnose, assist enterprises in reasonable adjustment and utilization of resources.
1、现场参观、与企业领导及质量管理人员交谈，了解企业现况；
1. Visit the site, talk with enterprise leaders and quality management personnel, and understand the current situation of the enterprise;
2、依据GMP规范，结合企业现况制定切实可行的GMP整改方案；
2. Formulate practical GMP rectification plans according to GMP specifications and in combination with the current situation of the enterprise;
3、协助企业建立或优化质量管理组织架构；
3. Assist enterprises to establish or optimize the quality management organization structure;
4、协助企业成立内部GMP认证小组；
4. Assist the enterprise to establish an internal GMP certification team;
（二）GMP实施阶段：
（2） GMP implementation stage:
GMP初次培训：
GMP initial training:
5、讲述GMP基础知识及企业实施GMP的意义。
5. Describe the basic knowledge of GMP and the significance of implementing GMP in enterprises.
协助企业进行硬件改造：
Assist enterprises in hardware Transformation:
6、为企业提供规范可行的硬件改造意见；
6. Provide standardized and feasible hardware transformation suggestions for enterprises;
7、监督检查改造过程及对改造效果的评价；
7. Supervise and inspect the transformation process and evaluate the transformation effect;
8、GMP软件体系建立、实施磨合；
8. Establish and implement GMP software system;
GMP软件体系建立、实施磨合：
Establishment and implementation of GMP software system:
9、GMP文件编写（内容、格式）培训；
9. GMP document preparation (content, format) training;
10、GMP文件初稿审核、修改；
10. Review and modify the first draft of GMP documents;
11、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；
11. Supervise and check the operation of GMP documents in actual work, adjust and improve them, and then run in;
企业拟订内审计划、方案；
The enterprise draws up internal audit plans and programs;
参与内审过程，针对发现的问题提出改进措施；
Participate in the internal audit process and put forward improvement measures for the problems found;
通过改进来完善GMP体系；
Improve the GMP system through improvement;
（三）GMP认证申报：
（3） GMP certification declaration:
GMP认证申报资料准备及申报：
Preparation and application of GMP certification application materials:
GMP文件编写（内容、格式）培训；
GMP document preparation (content, format) training;
GMP文件初稿审核、修改；
Review and modify the first draft of GMP documents;
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；
Supervise and check the operation of GMP documents in actual work, adjust and improve them, and then run in;
（四）GMP认证阶段：
（4） GMP certification stage:
预认证,迎接GMP现场检查：
Pre certification to meet GMP on-site inspection:
GMP认证前的迎审培训；
Training before GMP certification;
对企业预先认证,发现问题及时改进；
Pre certification of enterprises and timely improvement of problems found;
高效维护GMP体系运行，迎接GMP检查组现场检查；
Effectively maintain the operation of GMP system and meet the on-site inspection of GMP inspection team;
（五）GMP认证结束：
（5） End of GMP certification:
GMP认证结果跟进及领取证书：
Follow up the GMP certification results and get the certificate:
企业通过GMP现场检查后的进度跟踪；
Progress tracking after the enterprise passes the GMP on-site inspection;
领取GMP证书。
Get GMP certificate.
以上就是为大家介绍的有GMP咨询公司的详细的介绍,希望对您有所帮助.如果您有什么疑问的话,欢迎联系我们.我们将以专业的态度,为您提供服务https://www.fmkgmp.com
The above is a detailed introduction of GMP consulting company. I hope it can help you. If you have any questions, please contact us. We will provide services for you with a professional attitude https://www.fmkgmp.com