现场注册核查应对

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由于新产品从研制至生产耗时长，企业人员变更频繁情况下，现任的质量管理人就得担此重任，从研制至检测至生产全过程熟悉，才能做到现场检查时，不慌不乱，有条不紊

                               
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gaowenhua

Due to the long time required for the development and production of new products, as well as frequent personnel changes in enterprises, the current quality management personnel have to bear this heavy responsibility. They must be familiar with the entire process from development to testing to production in order to ensure that on-site inspections are conducted calmly and orderly

                               
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组织机构图为最新版本且与现行管理人员匹配一致

                               
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The organizational chart is the latest version and matches the current management personnel

                               
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花名册，涵盖生产管理人员、质量管理人员、仓库管理人员、质量控制人员、采购人员等，以及关键人员资质。

                               
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Roster, covering production management personnel, quality management personnel, warehouse management personnel, quality control personnel, procurement personnel, as well as key personnel qualifications.

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企业营业执照，生产许可证，历次检查清单，GMP符合性检查；

                               
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Enterprise business license, production license, previous inspection checklist, GMP compliance inspection;

                               
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生产车间平面布局图、实验室布局图、仓库布局图、生产工艺流程图核查完整性。

                               
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Verify the completeness of the production workshop floor plan, laboratory layout, warehouse layout, and production process flow diagram.

                               
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