| 贾娜,王璐,王晓,李妮,邹雨,魏晶,赵红菊.化学药品注册批准前检查常见问题及思考[J].中国药事,2019,33(3):246-249 |
| 化学药品注册批准前检查常见问题及思考 |
| Problems and Reflections on Pre-approval Inspection of Chemical Drug Registration |
| 投稿时间：2018-11-02 |
| DOI：10.16153/j.1002-7777.2019.03.002 |
| 中文关键词: 化学药品 注册 批准前检查 问题 思考 |
| 英文关键词: chemical drugs registration pre-approval inspection problems reflection |
| 基金项目: |
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| 摘要点击次数: 1555 |
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| 中文摘要: |
| 目的：对化学药品批准前检查过程中发现的问题进行汇总，为药品审评审批制度改革新形势下生产企业提供参考。方法：结合当前法律法规以及药品注册检查要求，对药品注册生产现场检查过程中发现的问题进行归类分析，从人员、厂房与设施、设备、物料、文件、生产和质量管理七部分进行阐述。结果与结论：通过认证的药品生产企业在现场检查过程中出现各类问题，应在检查前做好充分工作，同时严格按照GMP要求进行管理，以期生产出高质量的药品。 |
| 英文摘要: |
| Objective:To summarize the problems found in pre-approval inspection of chemical drugs so as to provide references for pharmaceutical manufacturers under the new situation of the reform of the drug review and approval system. Methods:Combined with the current laws and regulations as well as the requirements of drug registration inspection, the problems found during the on-site inspection of production process for drug registration were classified and analyzed. Seven parts including personnel, plants and facilities, equipment, materials, documents, production and quality management were discussed. Results and Conclusion:Certified pharmaceutical manufacturers still had all kinds of problems in the process of on-site inspection. Full preparations should be made before the inspection, and management should be carried out in strict accordance with GMP requirements in order to produce drugs with high quality. |
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