生化药品GMP附录实施情况的分析与探讨
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摘要
目的:《药品生产质量管理规范》(2010年修订)生化药品附录的颁布和实施,对生化药品生产企业提出了新要求。本文对生化药品GMP附录的实施情况进行了分析,对如何进一步推进生化药附录的实施提出了建议。方法:通过对附录实施前后国内生化药品检查情况汇总分析,阐述部分生化药品生产企业还存在一些薄弱环节,建议从生化药品生产企业贯彻落实GMP附录和进一步加强生化药品生产监管工作两方面加以推进。结果与结论:生化药品生产企业的质量管理与生化药品附录的要求存在一定差距,尤其是在供应链管理方面。在药品监督检查中,必要时应进行延伸检查,从源头进行监管。
Objective: The new annex of Good Manufacturing Practice(2010 Revision), which is for biochemical drugs, has put forward many new requirements for biochemical drug manufacturing companies. This paper analyzed the implementation of the new annex for biochemical drugs and put forward suggestions on how to further promote the implementation of the new annex for biochemical drugs. Methods: Inspection results of domestic biochemical drugs before and after the implementation of the new annex were analyzed, which brought forward the conclusion that there were still some gaps between the expectation of the annex and the current situation. It is suggested that the biochemical drug production enterprises should implement the annex as soon as possible, and the drug supervision and administration organizations should further strengthen the supervision. Results and Conclusion: There is still a certain gap between the quality management of biochemical drug manufacturing companies and the requirements of the new annex for biochemical drugs, especially in the aspect of supply chain management. Therefore, additional inspection should be carried out in drug supervision and inspection when necessary and supervision should be conducted from the source.
Objective: The new annex of Good Manufacturing Practice(2010 Revision), which is for biochemical drugs, has put forward many new requirements for biochemical drug manufacturing companies. This paper analyzed the implementation of the new annex for biochemical drugs and put forward suggestions on how to further promote the implementation of the new annex for biochemical drugs. Methods: Inspection results of domestic biochemical drugs before and after the implementation of the new annex were analyzed, which brought forward the conclusion that there were still some gaps between the expectation of the annex and the current situation. It is suggested that the biochemical drug production enterprises should implement the annex as soon as possible, and the drug supervision and administration organizations should further strengthen the supervision. Results and Conclusion: There is still a certain gap between the quality management of biochemical drug manufacturing companies and the requirements of the new annex for biochemical drugs, especially in the aspect of supply chain management. Therefore, additional inspection should be carried out in drug supervision and inspection when necessary and supervision should be conducted from the source.
引文
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[2]张天民,姚世文,唐永业.中国生化制药工业协会关于生化药物的定义和范围的建议[J].中国生化药物杂志,1995,(5):43-44.
[3]任丽萍,范慧红.我国生化药品的质量现状与展望[J].中国生化药物杂志,2016,10(36):1-4.
[4]卫生部.卫生部令第79号药品生产质量管理规范(2010年修订)[EB/OL].[2018-04-20].http://samr.cfda.gov.cn/WS01/CL1031/58500.html.
[5]许健.浅析新版GMP生化附录对生化制药企业的影响及对策[J].现代医学与健康研究,2017,(6):148.
[6]国家食品药品监督管理总局.生化药品附录[S].2017.
[7]贾晓艳.我国GMP附录《生化药品》简析[J].机电信息,2018,(8):1-3.
[8]广东省食品药品监督管理局审评认证中心.生化药企业洗牌加速[EB/OL].[2018-04-20].http://www.gdda.gov.cn/publicfiles/business/htmlfiles/gddec/splzckxx/201710/344105.htm.
[9]国家食品药品监督管理总局关于武汉华龙生物制药有限公司违法生产小牛血去蛋白提取物注射液的通告(2015年第21号)[EB/OL].[2018-04-20].http://samr.cfda.gov.cn/WS01/CL0087/121863.html.
[10]訾鹏.百特公司两种肝素钠误用发生医疗事故[J].中华医学信息导报,2007,(5):3-3.
[11]国家食品药品监督管理总局.2016年度药品检查报告[S].2017.
[12]国家食品药品监督管理总局.总局办公厅关于开展生化药品专项检查的通知(2017第135号)[EB/OL].[2017-10-10].http://www.gov.cn/xinwen/2017-10/10/content_5230810.htm
[13]重庆市食品药品监督管理局.2017年生化药品专项检查情况公示[S].2017.
[14]天津市场和质量监督管理委员会.关于2017年药品生产企业GMP跟踪检查暨京津冀联合检查情况的通告[EB/OL].[2018-04-20].http://www.tjmqa.gov.cn/xwzx/gs/yp GMPrz/20242.html.
[15]海南省食品药品监督管理局.2017年11月药品生产监督检查情况通报[S].2017.