| 钱利武,罗京京,王浩,刘小琼,王慧.药品GMP检查中质量控制与质量保证方面存在的主要问题及建议[J].中国药事,2020,34(1):17-21 |
| 药品GMP检查中质量控制与质量保证方面存在的主要问题及建议 |
| Main Problems of Quality Control and Quality Assurance in Drug GMP Inspection and the Suggestions |
| 投稿时间：2019-05-29 |
| DOI：10.16153/j.1002-7777.2020.01.003 |
| 中文关键词: GMP 质量控制与质量保证 缺陷项目 上市许可持有人 |
| 英文关键词: GMP quality control and quality assurance defective item MAH |
| 基金项目: |
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| 中文摘要: |
| 目的：探讨安徽省药品GMP检查中质量控制和质量保证方面缺陷项目的分布规律和特点，为药品上市许可持有人有针对性地提升质量控制与质量保证水平和监管部门加强药品生产监管提供依据和思路。方法：对2017-2018年安徽省230家药品生产企业GMP现场检查中发现的质量控制与质量保证方面缺陷项目进行汇总分析。结果：大多数企业对样品检验、实验室物料管理和偏差调查等方面的条款理解不透彻，执行不到位，与药品GMP要求有一定差距。结论：药品上市许可持有人是药品质量的责任主体，应不断提高认识，在药品的质量控制与质量保证方面持续改进，确保人民群众的用药安全有效。 |
| 英文摘要: |
| Objective: To explore the distribution and characteristics of defective items in quality control and quality assurance in drug GMP inspection of Anhui Province, and provide evidences and ideas for drug marketing authorization holders (MAH) to improve quality control and quality assurance level and for regulation departments to strengthen drug production regulation. Methods: The defective items in quality control and quality assurance found in the on-site GMP inspection of 230 pharmaceutical manufacturers of Anhui province from 2017 to 2018 were summarized and analyzed. Results: Most enterprises did not fully understand the terms of sample testing, laboratory material management and deviation survey, and the implementation was not in place. There was a certain gap with the GMP requirements for drugs. Conclusion: MAH, the main body responsible for the quality of drugs, should continuously improve awareness, the quality control and quality assurance of drugs, and ensure the safety and effectiveness of drugs. |
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