| 引用本文: | 赵柳入,王洁云,董光辉,黄海波,叶明良,方玲,金朱明,曹王丽.药物主文件管理制度对药品制剂原料供应商管理的意义[J].中国现代应用药学,2015,32(12):1515-1517. |
| ZHAO Liuru,WANG Jieyun,DONG Guanghui,HUANG Haibo,YE Mingliang,FANG Ling,JIN Zhuming,CAO Wangli.Significance of Drug Master Files in the Management of Pharmaceutical Raw Material Suppliers[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(12):1515-1517. |
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| 摘要: |
| 目的 引入药物主文件(drug master files，DMF)管理制度以解决现有供应商管理中存在的各种问题，从根源上保证药品制剂质量。方法 运用DMF管理制度对供应商进行管理，并分析其优势。结果与结论 DMF管理制度，可以提高供应商现场审计的准确性和客观性，降低审计的质量风险，减少审计成本，保证供应商管理的质量，于原料供应商、药品制剂厂家以及药监部门三方有益，不仅使供应商现场审计真正落到实处，供应商管理更加有效，更能有效保障药品制剂的质量。 |
| 关键词: 原料 供应商管理 现场审计 药物主文件 |
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| Significance of Drug Master Files in the Management of Pharmaceutical Raw Material Suppliers |
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ZHAO Liuru1, WANG Jieyun1, DONG Guanghui2, HUANG Haibo2, YE Mingliang2, FANG Ling2, JIN Zhuming2, CAO Wangli2
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1.Zhejiang HaCon Pharmaceutical Co., Ltd., Hangzhou 310018, China;2.Zhejiang CONBA Pharmaceutical Co., Ltd., Zhejiang Provincial Key Laboratory of Traditional Chinese Medicine Pharmaceutical Technology, Hangzhou 310052, China
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| Abstract: |
| OBJECTIVE To solve various problems existing in the management of pharmaceutical raw material suppliers and to guarantee the quality of pharmaceutical preparations from the source by introducing drug master files(DMF) management system. METHODS DMF management system was used to manage the supplier. The advantages of this method was analyzed. RESULTS & CONCLUSION By using this method, it may improve the accuracy and objectivity of suppliers on-site auditing, reduce the quality risk and the cost of on-site audit, and guarantee the quality of suppliers on-site auditing. This method is beneficial to the raw material suppliers, pharmaceutical manufacturers and authorities. It also will make the suppliers on-site auditing be implemented truly, and guarantee the quality of pharmaceutical preparations better. |
| Key words: raw material the management of supplier on-site audit drug master files |
