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| 完善制药企业药品研发质量管理体系的探讨 |
| Discussion on improving the quality management system of R&D in pharmaceutical enterprises |
| 投稿时间：2019-03-25 修订日期：2019-06-03 |
| DOI： |
| 中文关键词: 制药企业 药品研发 质量管理体系 |
| 英文关键词: pharmaceutical enterprises pharmaceutical product R&D; quality management system |
| 基金项目: |
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| 中文摘要: |
| 目的：为我国制药企业药品研发质量管理体系的建立和完善提供建议与思考。方法：通过分析我国和FDA药品监管机构的检查报告、访谈制药企业研发质量管理负责人，了解我国制药企业研发质量管理的现状，为研发质量管理体系的建立和完善提供建议。结果与结论：完善的药品研发质量管理体系应包括以下几点：①设立独立的研发质量管理部门并充分赋权；②分类建立文件体系，使质量管理有章可循；③加强培训，确保培训效果；④建立有效的质量考核管理制度，确保质量体系有效运行。 |
| 英文摘要: |
| Objective: To provide concerns and suggestions for the establishment and improvement of the quality management system for R&D in pharmaceutical companies in China. Methods: Analyze the inspection report from FDA and China"s pharmaceutical regulatory authority, interview the person in charge of R&D quality management, and understand the status quo of R&D quality management in pharmaceutical companies in China. Ultimately provide suggestions of the establishment and improvement of R&D quality management system. Results and Conclusion: The perfect quality management system for pharmaceutical product R&D should include the following points: ①Establish an independent R&D quality management department, clarify relevant responsibilities and fully empower it to ensure the responsibility of R&D quality; ②Establish a document system to ensure quality management; ③Strengthen training and ensure the effectiveness of training; ④Establish an effective quality assessment system to ensure the effective operation of the quality system. |
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