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检查要点1：组织机构图 （组织机构图来源于文件，不能只下个红头文，一切都要有文件支持）。
Check point 1: organization chart (the organization chart comes from documents, not just the next red headline, but everything should be supported by documents).
检查要点2：质量部是否独立设置、是否参与所有质量活动及审核GMP文件；
Inspection point 2: whether the quality department is set up independently, whether it participates in all quality activities and reviews GMP documents;
检查要点3：关键人员的职责是否清晰完整，招聘时也要有文件支持。如：资历、经验、技能等方面都要有文件作出规定；
Check point 3: whether the responsibilities of key personnel are clear and complete, and there should be document support during recruitment. For example, qualifications, experience, skills and other aspects shall be stipulated in documents;
检查要点4：企业负责人与实际负责人的关系，是否有授权；
Key point 4: whether the relationship between the person in charge of the enterprise and the actual person in charge is authorized;
检查要点5：培训管理部门的职责、年度培训计划、培训计划、培训方案、相关记录、培训考核、培训跟踪等。每个企业都存在人员培训不到位的情况，人员可以有培训不到位的现象出现但是有关培训的一整套文件不能有问题；
Key inspection points 5: responsibilities of training management department, annual training plan, training plan, training scheme, relevant records, training assessment, training tracking, etc. Every enterprise has the situation that the personnel training is not in place. The personnel can have the phenomenon that the training is not in place, but there can be no problem with the whole set of documents related to training;
检查要点6：卫生 人员更衣程序、健康体检、参观人员管理、工衣工服工鞋是否有编号、服装的清洁应有记录（先风险评估后作出的规定）。
Key inspection points 6: changing procedures of health personnel, physical examination, management of visitors, whether work clothes and shoes are numbered, and the cleaning of clothes should be recorded (regulations made after risk assessment).
以上就是为大家介绍的有关GMP审计公司的详细的介绍,希望对您有所帮助.如果您有什么疑问的话,欢迎联系我们.我们将以的态度,为您提供服务https://www.fmkgmp.com
The above is the detailed introduction of GMP audit company. I hope it will be helpful to you If you have any questions, please contact us We will provide service for you with our attitude https://www.fmkgmp.com