湖北省注射剂类药品生产质量管理规范认证实施现状分析
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摘要
目的为省级药品监管部门实施注射剂类药品生产质量管理规范(GMP)认证提供参考。方法汇总湖北省通过药品GMP认证的10家注射剂类高风险药品生产企业产品质量相关的基本情况,并分析相关问题。结果企业产品自检合格率由认证工作下放前的95.50%提升至下放后的99.98%,管理质量稳步提升,但在注册工艺变更、企业技术人员储备和检查员培训方面还有待进一步提升。结论药品GMP认证检查工作下放成功,建议进一步缩短注册工艺变更的审批时间,加强对企业和地方局检查员的培训和指导。
Objective To provide a reference for provincial drug regulatory departments to implement Good Manufacturing Practices (GMP) certification for injection drugs.Methods The basic situation of product quality of 10 high-risk injection drugs enterprises in Hubei province which had passed GMP certification was summarized,and the related problems were analyzed.Results The qualified rate of self-inspection of enterprise products increased from 95.50% before the decentralization of certification to 99.98% after the decentralization.The quality of management has been steadily improved,but there was still space for further improvement in registration process change,enterprise technical personnel reserve and inspector training.Conclusion The decentralization of drugs GMP certification and inspection is successful,it is suggested that the examination and approval time of registration process changes should be further shortened and the training and guidance for enterprises and inspectors of local bureaus be strengthened.
Objective To provide a reference for provincial drug regulatory departments to implement Good Manufacturing Practices (GMP) certification for injection drugs.Methods The basic situation of product quality of 10 high-risk injection drugs enterprises in Hubei province which had passed GMP certification was summarized,and the related problems were analyzed.Results The qualified rate of self-inspection of enterprise products increased from 95.50% before the decentralization of certification to 99.98% after the decentralization.The quality of management has been steadily improved,but there was still space for further improvement in registration process change,enterprise technical personnel reserve and inspector training.Conclusion The decentralization of drugs GMP certification and inspection is successful,it is suggested that the examination and approval time of registration process changes should be further shortened and the training and guidance for enterprises and inspectors of local bureaus be strengthened.
引文
[1]国家卫生部.卫生部令第79号药品生产质量管理规范(2010年修订)[EB/OL].(2011-01-17)[2018-01-28].http://www.moh.gov.cn/mohzcfgs/pgz/201102150620.shtml.
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[3]张纪辉,邵蓉.新版GMP实施过程中亟需关注的问题与对策[J].中国药事,2012,26(1):88-92.
[4]王铁军,张彪,王波,等.我国高等药学教育的现状与发展趋势[J].中国药业,2017,26(3):93-96.
[5]梁静频,王燕祖.GMP修订带来洁净厂房的改革[J].中国医药生物技术,2009,2(4):15-16.
[6]徐魁,刘贵银,樊兆虎.药品GMP实施及认证中偏差分析、风险评估、质量回顾分析的探讨[J].中国药事,2014,28(4):361-364.
[7]邓萍,梁毅.新版GMP要求下的文件管理解析[J].机电信息,2011(26):22-25.
[8]周玲,谭文红.云南省药品生产企业GMP认证检查缺陷项目统计分析[J].中国药业,2016,25(14):16-19.
[9]汪丽,黄森,贾娜,等.药品注册研制现场核查的常见问题及管理建议[J].中国药事,2016,30(4):364-368.
[10]马韶青.论我国中药法律监管机制的完善[J].中国药业,2017,26(3):4-7.
[11]陈相龙,张国强,黎幼龙,等.我国执业药师资格制度存在的问题及对策[J].医学与社会,2017,30(1):15-18.
[12]邓婷,施健,杨成钢.我国GMP认证专职检查员队伍建设模式及对策研究[J].中国药事,2016,30(8):756-761.
[13]贾娜,李妮,赵红菊,等.辽宁省新修订药品GMP认证检查质量保证方面存在的缺陷及改进建议[J].中国药事,2015,29(7):721-724.
[14]周戈耀,陈文佼,田海玉,等.贵州省医药生产企业施行新版《药品生产质量管理规范》的现状研究[J].中国药房,2017,28(7):865-868.
[15]毕军,邹毅.中美药品GMP检查体系对比分析[J].中国药事,2013,27(6):578-583.
[16]陈方.澳大利亚对境外制药企业GMP认证简介[J].中国新药杂志,2017,26(18):2177-2180.
[2]陈相龙.德国和英国药品监督管理工作概况及对我国的启示[J].医药导报,2016,35(6):670-674.
[3]张纪辉,邵蓉.新版GMP实施过程中亟需关注的问题与对策[J].中国药事,2012,26(1):88-92.
[4]王铁军,张彪,王波,等.我国高等药学教育的现状与发展趋势[J].中国药业,2017,26(3):93-96.
[5]梁静频,王燕祖.GMP修订带来洁净厂房的改革[J].中国医药生物技术,2009,2(4):15-16.
[6]徐魁,刘贵银,樊兆虎.药品GMP实施及认证中偏差分析、风险评估、质量回顾分析的探讨[J].中国药事,2014,28(4):361-364.
[7]邓萍,梁毅.新版GMP要求下的文件管理解析[J].机电信息,2011(26):22-25.
[8]周玲,谭文红.云南省药品生产企业GMP认证检查缺陷项目统计分析[J].中国药业,2016,25(14):16-19.
[9]汪丽,黄森,贾娜,等.药品注册研制现场核查的常见问题及管理建议[J].中国药事,2016,30(4):364-368.
[10]马韶青.论我国中药法律监管机制的完善[J].中国药业,2017,26(3):4-7.
[11]陈相龙,张国强,黎幼龙,等.我国执业药师资格制度存在的问题及对策[J].医学与社会,2017,30(1):15-18.
[12]邓婷,施健,杨成钢.我国GMP认证专职检查员队伍建设模式及对策研究[J].中国药事,2016,30(8):756-761.
[13]贾娜,李妮,赵红菊,等.辽宁省新修订药品GMP认证检查质量保证方面存在的缺陷及改进建议[J].中国药事,2015,29(7):721-724.
[14]周戈耀,陈文佼,田海玉,等.贵州省医药生产企业施行新版《药品生产质量管理规范》的现状研究[J].中国药房,2017,28(7):865-868.
[15]毕军,邹毅.中美药品GMP检查体系对比分析[J].中国药事,2013,27(6):578-583.
[16]陈方.澳大利亚对境外制药企业GMP认证简介[J].中国新药杂志,2017,26(18):2177-2180.