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Key points on direct distribution for national drug reference standards
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Zhi-feng GAO, Xin-yue XIAO, Li-mei CAO, Li-hua XIE, Jing-yu JIANG, Jun-juan SHAO
Chinese Journal of New Drugs | 2021, 30(1) : 13 - 16
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Chinese Journal of New Drugs | 2021, 30(1): 13-16
Key points on direct distribution for national drug reference standards
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Zhi-feng GAO, Xin-yue XIAO, Li-mei CAO, Li-hua XIE, Jing-yu JIANG, Jun-juan SHAO
Affiliations
  • National Institute for Food and Drug Control, Beijing 102629, China
Published: 2021-01-15
Outline
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Reference standards are important material basis for drug control, meanwhile legal distribution of the national drug reference standards is one of the basic functions of NIFDC. A reform of distribution model for reference standard has been carried out by NIFDC in 2019, which changed the past two-level distribution and fully implemented direct distribution to users. Some key points are applied by NIFDC who faces the increasing workload and strict quality control requirements, including adjusting process links, establishing distribution traceability system, founding 9 steps of packaging procedure, building limitation of transportation and so on. As a result, smooth transition to direct distribution was realized. In order to provide guidance to improve the efficiency of reference standard management, this article summarizes the methods of efficiency improvement, analyzes the strategies of quality control, and combs the process nodes. In addition to the above points, some conclusions are made, such as the foundation to direct distribution was providing resources effectively, the powerful tool was intelligent external distribution platform, the significant guarantee was training and guiding users to order correctly.

drug  /  reference standards  /  distribution
高志峰, 肖新月, 曹丽梅, 谢丽华, 姜晶钰, 邵俊娟. 国家药品标准物质一级直供的实施要点研究. 中国新药杂志, 2021 , 30 (1) : 13 -16 .
Zhi-feng GAO, Xin-yue XIAO, Li-mei CAO, Li-hua XIE, Jing-yu JIANG, Jun-juan SHAO. Key points on direct distribution for national drug reference standards[J]. Chinese Journal of New Drugs, 2021 , 30 (1) : 13 -16 .
Year 2021 volume 30 Issue 1
30
5
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  • Online Date:2026-10-29
  • Published:2021-01-15
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  • Accepted:2020-04-01
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    National Institute for Food and Drug Control, Beijing 102629, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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