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我国药品生产质量管理规范检查质量评价体系构建研究

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目前我国药品生产质量管理规范(GMP)检查质量评价方面没有特别统一的标准和可实施的参照标准,为进一步推进和完善我国药品GMP检查制度,提升药品GMP检查质量,本研究通过文献研究和专家访谈的方法设计出调查问卷,然后通过调查研究形成我国药品GMP检查质量评价指标,构建了药品GMP检查质量评价体系.本文新构建的GMP检查质量评价体系和可行性的实证方案建议有助于进一步推进我国药品GMP相关检查工作,提升检查水平.
Study on the construction of the quality evaluation system of Chinese drug GMP inspection
At present,there is no particularly unified standard or implementable reference standard for the quality evaluation of drug GMP inspection in China.In order to further promote and improve the drug GMP inspection system in China and improve the quality of drug GMP inspection,a survey questionnaire was designed through literature research and expert interviews.The quality evaluation indicators were developed for drug GMP inspection in China through investigation and research,and then a drug GMP inspection quality evaluation system was constructed.The newly constructed GMP inspection quality evaluation system and feasible empirical plan suggestions in this article will help further promote China's drug GMP-related inspection work and improve the level of inspection.

GMPinspection qualityevaluation indexevaluation system

胡士高、武志昂

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沈阳药科大学工商管理学院,沈阳 110016

安徽省药品审评查验中心,合肥 230051

沈阳药科大学亦弘商学院,北京 100055

生产质量管理规范 检查质量 评价指标 评价体系

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子:1.039
ISSN:1003-3734
年,卷(期):2024.33(3)
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