| 利用期间核查确认药品标准物质特性量值溯源性 |
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| 引用本文： | 常艳,马双成,胡昌勤.利用期间核查确认药品标准物质特性量值溯源性[J].中国药事,2013(9):922-927. |
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| 作者姓名： | 常艳 马双成 胡昌勤 |
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| 作者单位： | 中国食品药品检定研究院,北京100050 |
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| 基金项目： | 重大新药创制—化学新药质量标准研究与评价技术平台（编号2011ZX09303） |
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| 摘 要： | 目的探讨期间核查在保证药品标准物质特性量值溯源性中的作用。方法根据药品标准物质研制的特点,找出研制过程中可能影响标准物质特性量值溯源有效性的关键因素,参照ISO/IEC 17025：2005《检测和校准实验室能力的通用要求》确定其中需要进行期间核查的对象,并选择适宜的核查参数和与其相适宜的结果判定依据。结果与结论通过期间核查的方式,可以确认药品标准物质研制过程中整个溯源体系的有效性。
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| 关 键 词： | 标准物质 期间核查 溯源性 特性量值 |
Traceability Demonstration of Characteristic Value of Pharmaceutical Reference Material through Intermediate Checks |
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| Chang Yah,Ma Shuangcheng and Hu Changqin.Traceability Demonstration of Characteristic Value of Pharmaceutical Reference Material through Intermediate Checks[J].Chinese Pharmaceutical Affairs,2013(9):922-927. |
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| Authors: | Chang Yah Ma Shuangcheng and Hu Changqin |
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| Institution: | (National Institutes for Food and Drug Control, Beijing 100050) |
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| Abstract: | Objective To investigate the effects of intermediate checks in assuring the traceability of characteristic value of pharmaceutical reference materials （PRMs）. Methods The key factors which may influence the validity of traceability were identified based on the particularities of PRMs. The objects, the appropriate parameters and the corresponding criterions of intermediate checks were chosen according to the basic requirements of ISO/IEC 17025： 2005, The general requirements for the competence of testing and calibration laboratories. Results and Conclusion The efficacy of the ideal trace system in the development process of PRMs was established through intermediate checks. |
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| Keywords: | reference material intermediate checkg traceability characteristic value |
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