| 引用本文：杜爽, 梁毅.仿制药一致性评价与全面质量管理一体化的解析[J].中国卫生政策研究,2017,10(8):40-43 |
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| 仿制药一致性评价与全面质量管理一体化的解析 |
| 投稿时间：2017-03-16 修订日期：2017-07-05 PDF全文浏览 HTML全文浏览 |
| 杜爽, 梁毅 |
| 中国药科大学国际医药商学院 江苏南京 211198 |
| 摘要:目的：将一致性评价体系与全面质量管理相结合，为实质性提高我国仿制药质量提出建议。方法：在明确我国仿制药现状的基础之上，结合现代过程质量控制理念，对一致性评价体系的缺陷进行全面分析。结果：一致性评价是结果质量评估的重要手段，但具有不全面性、辨识度不高、本身存在风险等缺陷，仅通过一致性评价并不能从源头与过程上有效提高仿制药质量。结论：良好的过程质量管理是一致性评价的基础，能够弥补结果评价的不足，降低高投入低质量产出的风险。因此，建议加速一致性评价与全面质量管理的标准化管理一体化进程，并将指纹图谱化的理念融入到质量管理当中，有效推动我国仿制药质量水平的提升。 |
| 关键词:仿制药 一致性评价 过程质量 全面质量管理 指纹图谱化 一体化 |
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| Analysis on the integration of generic consistency evaluation and total quality management |
| DU Shuang, LIANG Yi |
| School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing Jiangsu 211198, China |
| Abstract:Objective:To combine the consistency evaluation system with the total quality management, and put forward some suggestions for improving the quality of generic drugs in China. Methods:Based on the analysis of the quality of Chinese generic drugs, combined with the concept of modern process quality control, a comprehensive analysis was made on the defects of the consistency evaluation system. Results:The consistency evaluation was found to be very important for the evaluation of the results, but it is not comprehensive as the recognition is not high, and hence there are some risks in itself. As per the findings of this study, the quality of generic drugs cannot be effectively controlled and improved at two essential points, source and the process only through the consistency evaluation. Conclusions:A good process quality management is the basis of consistency evaluation, which can compensate for the deficiency of the evaluation of the results, and reduce the risk of high input and low quality output. Therefore, it is suggested that the assessment and the total quality management standardization should be integrated and accelerated, and integrate the concept of fingerprint into the quality management system to effectively promote the quality level of Chinese generic drugs. |
| Key words:Generic drugs Consistency evaluation Process quality Total quality management system Fingerprint Integration |
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