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跟踪检查广西壮族自治区31家药品生产企业实施新版GMP后的缺陷情况分析
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| 篇名： | 跟踪检查广西壮族自治区31家药品生产企业实施新版GMP后的缺陷情况分析 |
| TITLE： | |
| 摘要： | 目的：进一步提高药品生产企业对新版《药品生产质量管理规范》（GMP）的实施水平。方法：根据新版GMP标准及《药品生产现场检查风险评定指导原则》对广西辖区内11个地级市31家药品生产企业进行跟踪检查，分析药品生产企业实施新版GMP的缺陷及其原因并提出改进建议。结果与结论：31家药品生产企业中，通过新版GMP跟踪检查的有30家（96.8％）；共发现缺陷331项，集中在设备、厂房与设施、质量控制与质量保证3个方面，分别为76、47、43项，占所有缺陷项目比分别为23.0％、14.2％、13.0％。缺陷出现的原因主要为机构与人员培训，厂房与设施、设备管理维护及定期校验不到位；物料与产品未制定有效期或复验期；相关确认与验证内容不全；质量控制、保证和质量管理、文件和生产管理不规范、不完善；自检方案过于简单等。建议药品监管部门建立健全法律法规体系，探索药品GMP跟踪检查新模式（如突击检查、细化检查等），加强检查员队伍培训力度，统一检查尺度；药品生产企业应严格按照新版GMP的要求进行生产，注重对重点知识的更新，加强培训的针对性，通过多方合力切实有效地保证药品质量。 |
| ABSTRACT： | OBJECTIVE： To further enhance the implementation level of new Good Manufacturing Practices （GMP） in pharmaceutical enterprises. METHODS： Based on the new GMP criteria and Guidelines for Risk Assessment of Pharmaceutical Production Site Inspection， a tracking inspection was conducted for the 31 pharmaceutical enterprises in 11 prefecture-level cities of Guangxi area. Defects of implementing new GMP and their causes were analyzed， and the suggestions were put forward. RESULTS & CONCLUSIONS： In the 31 pharmaceutical enterprises， there were 30 enterprises （96.8％） passed the new GMP tracking inspection. Totally 331 defect items were found， focusing on equipment （76 items， 23.0％）， factory and facilities （47 items， 14.2％）， quality control and quality assurance （43 items， 13.0％）. Causes for defects were mainly institutions and staff training， factory and facilities， equipments management， maintenance and periodic check were far from satisfactory； material and product did not specify a validity period or a retest period； relevant confirmation was incomplete with verification； the quality control， assurance， management， document and production management were not standard and completed； and self-test program was too simple， etc. It is suggested that drug regulatory authorities should establish and improve the legal system， explore new patterns of drug GMP tracking inspection （such as sudden unannounced inspection， detailed inspection）， strengthen inspector team training and unify inspection scale. And the pharmaceutical enterprises should produce drugs in line with the requirements of new GMP， focus on the update of key knowledge， strengthen relevance of training to ensure the drugs quality effectively by multilateral force. |
| 期刊： | 2017年第28卷第19期 |
| 作者： | 陆仕华，韦莹莹，韦广辉 |
| AUTHORS： | LU Shihua，WEI Yingying，WEI Guanghui |
| 关键字： | 新版《药品生产质量管理规范》；缺陷；跟踪检查；质量管理体系 |
| KEYWORDS： | New Good Manufacturing Practices； Defect； Tracking inspection； Quality management system |
| 阅读数： | 317 次 |
| 本月下载数： | 8 次 |
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