| 浅析国外药品标准物质原料的采购与管理 |
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| 引用本文： | 陈亚飞等.浅析国外药品标准物质原料的采购与管理[J].中国药事,2014(3):251-254. |
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| 作者姓名： | 陈亚飞等 |
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| 作者单位： | [1]中国食品药品检定研究院,北京100050 [2]北京联合大学,北京100050 |
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| 摘 要： | 目的介绍药品标准物质原料采购国际通行做法，探讨建立标准物质原料采购与管理的科学机制。方法阐述药品标准物质的需求评价、技术可行性、原料的选择与管理、USP标准物质原料供应合作方认可和ISO导则34对原料采购的相关要求。结果与结论国外药品标准物质原料的采购与管理经验，对我国标准物质原料的可获得和管理具有借鉴意义。
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| 关 键 词： | 药品标准物质 原料采购 原料管理 |
Discussion on Procurement and Management of Pharmaceutical Candidates of Reference Standard |
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| Chen Yafei,Sun Yu.Discussion on Procurement and Management of Pharmaceutical Candidates of Reference Standard[J].Chinese Pharmaceutical Affairs,2014(3):251-254. |
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| Authors: | Chen Yafei Sun Yu |
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| Affiliation: | (National Institutes for Food and Drug Control, Beijing 100050 1Beijing Union University) |
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| Abstract: | Objective To discuss how to establish a mechanism for the procurement and management of reference materials. Methods Some conventional methods for the procurement of reference candidate materials were introduced and the assessment of demands, technical feasibility, candidate selection and management, suppliersr cooperation recognition program of USP, general requirements of ISO Guideline 34 for the procurement of reference materials were elaborated. Results and Conclusion The experience of foreign countries on the procurement and management of pharmaceutical reference materials could be a valuable reference to China for the availability and management of reference materials. |
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| Keywords: | pharmaceutical reference standards~ procurement of reference candidates~ managementof reference candidates |
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