| 曹鸿雁,韩莹,胡敬峰.山东省无菌制剂生产质量风险分析与探讨[J].中国药事,2018,32(7):901-905 |
| 山东省无菌制剂生产质量风险分析与探讨 |
| Analysis and Discussion on Product Quality Risk of Sterile Preparations in Shandong Province |
| 投稿时间：2018-02-09 |
| DOI：10.16153/j.1002-7777.2018.07.010 |
| 中文关键词: 无菌制剂 药品生产质量管理规范 缺陷项目 质量风险 |
| 英文关键词: sterile preparation GMP defective items quality risks |
| 基金项目: |
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| 中文摘要: |
| 目的：发现山东省无菌制剂生产企业在生产质量管理方面存在的共性缺陷问题，探讨无菌制剂生产企业存在的主要风险点，为无菌制剂企业更加规范地实施GMP提供参考。方法：对2016-2017年山东省承担的无菌制剂认证检查情况进行统计分析。结果与结论：企业需要关注确认与验证、无菌药品附录、质量控制与质量保证、机构与人员等方面存在的质量风险，有针对性地改进提升。 |
| 英文摘要: |
| Objective:To discover the common deficiency in production quality management of sterile preparation manufacturing enterprises, to analyze main risks of sterile preparation manufacturing enterprises, and to provide references for implementing standard good manufacturing practice (GMP). Methods:The accreditation and inspection results of sterile preparation manufacturing enterprises undertaken by Shandong Province from 2016 to 2017 were statistically analyzed. Results and Conclusion:The manufacturing enterprises should focus on qualification and validation, appendix of sterile drugs, quality control and quality assurance, quality risks of facility and personnel in order to improve them accordingly. |
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