药品生产企业GMP(2010年修订)飞行检查情况分析.PDFVIP

·药事管理 · 药品生产企业 GMP(2010 年修订)飞行检查情况分析  * 陆仕华，韦莹莹，李杉，韦广辉 (广西壮族自治区食品药品审评查验中心，南宁 530029) 摘要：目的 进一步了解药品生产企业在GMP(2010 年修订)飞行检查中存在缺陷的规律和特点，为监管部门的监管提出 一些针对性的建议和措施。方法 分析2017 年广西食品药品审评查验中心组织对辖区内 11 家药品生产企业进行飞行检 查发现的缺陷情况。结果 11 家药品生产企业接受飞行检查，4 家企业被收回《药品GMP 证书》，1 家企业被限期整改， 缺陷主要集中在 6 个方面，分别为企业未按批准处方工艺组织生产；人员培训不到位；物料与产品管理混乱；生产管理 不到位；质量控制与保证抓得不够严；企业数据可靠性不强。结论 企业应加强自律，更新观念，进一步完善GMP 体系， 监管部门应适应新时代要求，改变和创新监管工作思路，提高飞行检查的震慑力和权威性，促使药品生产企业持续按GMP 要求执行。 关键词：药品；GMP ；飞行检查；生产企业；数据可靠性 中图分类号：R951 文献标志码：B 文章编号：1007-7693(2019)02-0228-04 DOI: 10.13748/ki.issn1007-7693.2019.02.021 引用本文：陆仕华, 韦莹莹, 李杉, 等. 药品生产企业 GMP(2010 年修订)飞行检查情况分析[J]. 中国现代应用药学, 2019, 36(2): 228-231. Analysis on the Unannounced Inspection of GMP(2010) in Pharmaceutical Enterprises * LU Shihua, WEI Yingying, LI Shan, WEI Guanghui (Guangxi Food and Drug Evaluation Inspection Center, Nanning 530029, China) ABSTRACT: OBJECTIVE To know more about the rules and characteristics of defects on unannounced inspection of the GMP(2010) on pharmaceutical enterprises, to provide reference and measures for supervision department. METHODS Analyzing the defects found in the unannounced inspection of 11 pharmaceutical enterprises organized by Guangxi Food and Drug Evaluation Inspection Center in 2017. RESULTS Eleven pharmaceutical enterprises accepted unannounced inspection and 4 of them were deprived of GMP certificates. A total of 6 major deficiencies were found: enterprises failing to approve prescription technology to organize production, personnel’s training was affirmed to be insufficient, material and products management was ineffective, production management was nonstandard, quality control and quality assurances was