| 贾娜,赵红菊,汪丽.药品生产企业现场检查过程中计算机化管理系统存在的问题及对策[J].中国药事,2017,(2):127-129 |
| 药品生产企业现场检查过程中计算机化管理系统存在的问题及对策 |
| Problems and Countermeasures of Computerized System in On-site Inspection Process of Pharmaceutical Manufacturing Enterprises |
| 投稿时间：2016-08-11 |
| DOI：10.16153/j.1002-7777.2017.02.002 |
| 中文关键词: 药品生产质量管理规范 现场检查 计算机化管理系统 数据可靠性 |
| 英文关键词: GMP on-site inspection computerized system data integrity |
| 基金项目: |
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| 中文摘要: |
| 目的：对药品生产企业计算机化管理系统方面存在的问题进行归类分析，供相关单位借鉴和参考。方法：对药品生产企业进行《药品生产质量管理规范》（GMP）现场检查，探讨分析计算机化管理系统方面存在的问题。结果与结论：部分药品生产企业对于新法规不理解，执行不规范，不能完全保证数据的可靠性。应在日常GMP管理过程中逐步完善，为生产质量管理提供依据。 |
| 英文摘要: |
| Objective: To classify and analyze the problems of computerized system in pharmaceutical manufacturing enterprises, so as to provide references for the related enterprises.Methods: The existing problems were discussed through the feld inspection of pharmaceutical manufacturing enterprises.Results and Conclusion: With some drug manufacturers not understanding the new regulatory documents, and the implementation being not standardized, these manufacturers cannot fully guarantee the integrity of the data, which should be gradually improved in the daily GMP management process so as to provide the basis for production quality management. |
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