| 引用本文: | 王晓,王璐,高永宝,张纯刚.全球制药行业厂房与设施、设备类检查缺陷情况分析[J].中国现代应用药学,2020,37(10):1241-1247. |
| WANG Xiao,WANG Lu,GAO Yongbao,ZHANG Chungang.Analysis of Inspection Deficiencies of Buildings and Facilities, Equipment of Pharmaceutical Industry Worldwide[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(10):1241-1247. |
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| 摘要: |
| 目的 为我国药品监管和行业发展提供参考。方法 对近几年FDA、MHRA、CFDI及辽宁省药品GMP检查中厂房与设施、设备类的缺陷进行统计分析，从缺陷占比、高频缺陷等角度分析GMP检查缺陷在反映制药企业硬件水平方面的重要作用。结果与结论 从GMP检查缺陷角度发现了我国制药行业和发达国家的差距，为我国制药行业在厂房与设施、设备方面改进提出了建议。 |
| 关键词: 药品检查 厂房与设施 设备 缺陷 |
| DOI：10.13748/j.cnki.issn1007-7693.2020.10.017 |
| 分类号:R95 |
| 基金项目:国家自然科学基金项目（81503257）；国家重点研发计划（2018YFC1706903）；辽宁省博士启动基金（201501098） |
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| Analysis of Inspection Deficiencies of Buildings and Facilities, Equipment of Pharmaceutical Industry Worldwide |
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WANG Xiao1, WANG Lu1, GAO Yongbao1, ZHANG Chungang2
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1.Liaoning Inspection, Examination & Certification Center, Shenyang 110016, China;2.Liaoning University of Traditional Chinese Medicine, Dalian 116600, China
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| Abstract: |
| OBJECTIVE To provide reference for drug supervision and industry development in China. METHODS The GMP inspection deficiencies about buildings and facilities, equipment which were issued by FDA, MHRA, CFDI and Liaoning drug regulatory agency in recent years were analyzed, and the important role of GMP inspection deficiencies in reflecting the hardware level of pharmaceutical enterprises was analyzed from the perspective of deficiency proportion and high frequency deficiencies. RESULTS & CONCLUSION The gap between China and developed countries in buildings and facilities, equipment is found from the perspective of GMP inspection deficiencies. Suggestions are put forward for the improvement of buildings and facilities, equipment of China's pharmaceutical industry. |
| Key words: drug inspection buildings and facilities equipment deficiency |
