药品生产企业GMP(2010年修订)飞行检查情况分析
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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。
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 poor and data was not reliable. CONCLUSION The enterprises shall innovate themselves, update their concepts, improve the GMP system. The supervision department shall change and innovate the regulatory thinking, to improve the deterrentness and authority of unannounced inspection, and encourage pharmaceutical enterprises to continuously implement the GMP.
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 poor and data was not reliable. CONCLUSION The enterprises shall innovate themselves, update their concepts, improve the GMP system. The supervision department shall change and innovate the regulatory thinking, to improve the deterrentness and authority of unannounced inspection, and encourage pharmaceutical enterprises to continuously implement the GMP.
引文
[1]国家食品药品监督管理总局令第14号[S].2015.
[2]国家食品药品监督管理总局.中华人民共和国药品管理法:修正案(草案征求意见稿)[EB/OL].[2017-10-23].http://www.sda.gov.cn/WS01/CL0050/178902.html.
[3]药品生产质量管理规范(2010年修订)[S].卫生部令第79号,2010.
[4]WANG L,ZHAO H J,MA H.On defective items according to2010 edition GMP certification in Liaoning province[J].Chin Pharm Affa(中国药事),2017,31(5):520-523.
[5]黄爱玲,赵华强.新版GMP药品实施过程中发现的问题及监管[J].中国医药指南,2014,12(2):374-375.
[6]LIU X L,HAN D B,LIU Q H.Defective items analysis and improvement suggestions on the new revised medicine GMPcertification and inspection of Chinese herbal pieces production enterprises in Qinghai province[J].Chin Pharm Affa(中国药事),2016,30(9):896-873.
[7]ZHANG T J,HAN W T,HAN J.Impact of data integrity on GMP inspection of Chinese pharmaceutical manufacturers[J].Chin J New Drugs(中国新药杂志),2017,26(9):985-989.
[8]FENG G,LIANG Y.Thoughts on improving data integrity of pharmaceutical production enterprises[J].China Pharm(中国药房),2017,28(13):1732-1735.
[9]CUI Y M,MO Y N,ZHOU P.Analysis of current situation and countermeasures of supervision of Chinese herbal medicine pharmacy management perspective[J].Lishizhen Med Mater Med Res(时针国医国药),2017,28(8):2004-2006.
[10]刘龙茜,张丽青.药品生产企业GMP飞行检查的研究与分析[J].企业改革与管理,2016(12):222.
[11]刘艳春.药品生产企业在新版GMP检查中存在的问题及改进措施[J].机电信息,2016,32(494):17-20.
[2]国家食品药品监督管理总局.中华人民共和国药品管理法:修正案(草案征求意见稿)[EB/OL].[2017-10-23].http://www.sda.gov.cn/WS01/CL0050/178902.html.
[3]药品生产质量管理规范(2010年修订)[S].卫生部令第79号,2010.
[4]WANG L,ZHAO H J,MA H.On defective items according to2010 edition GMP certification in Liaoning province[J].Chin Pharm Affa(中国药事),2017,31(5):520-523.
[5]黄爱玲,赵华强.新版GMP药品实施过程中发现的问题及监管[J].中国医药指南,2014,12(2):374-375.
[6]LIU X L,HAN D B,LIU Q H.Defective items analysis and improvement suggestions on the new revised medicine GMPcertification and inspection of Chinese herbal pieces production enterprises in Qinghai province[J].Chin Pharm Affa(中国药事),2016,30(9):896-873.
[7]ZHANG T J,HAN W T,HAN J.Impact of data integrity on GMP inspection of Chinese pharmaceutical manufacturers[J].Chin J New Drugs(中国新药杂志),2017,26(9):985-989.
[8]FENG G,LIANG Y.Thoughts on improving data integrity of pharmaceutical production enterprises[J].China Pharm(中国药房),2017,28(13):1732-1735.
[9]CUI Y M,MO Y N,ZHOU P.Analysis of current situation and countermeasures of supervision of Chinese herbal medicine pharmacy management perspective[J].Lishizhen Med Mater Med Res(时针国医国药),2017,28(8):2004-2006.
[10]刘龙茜,张丽青.药品生产企业GMP飞行检查的研究与分析[J].企业改革与管理,2016(12):222.
[11]刘艳春.药品生产企业在新版GMP检查中存在的问题及改进措施[J].机电信息,2016,32(494):17-20.