Risk Analysis and Countermeasures of Laboratory Management of National Drug Sampling and Testing Institutions
10.3870/j.issn.1004-0781.2025.01.008
- VernacularTitle:国家药品抽检检验机构实验室管理风险点分析及对策
- Author:
Jialiang ZHU
1
;
Hao XI
;
Lei FENG
;
Miao XU
;
Songqing GU
;
Rui LI
;
Ting SUN
;
Lei CHEN
Author Information
1. 中国食品药品检定研究院,北京 102629
- Publication Type:Journal Article
- Keywords:
National drug sampling and testing;
Laboratory management;
Risk point analysis
- From:
Herald of Medicine
2025;44(1):68-72
- CountryChina
- Language:Chinese
-
Abstract:
Objective To summarize the potential risk factors that may arise in the national drug sampling and testing inspection process in recent years,to focuse on the operation of the quality management system,and to put forward proposals on how to do a good job under the new drug regulatory model of sampling and testing work.Methods Focusing on the investigation of data integrity and authenticity,the analysis focuses on the analysis of risk points such as reagent management,standard substance management,instrument,and facility management,electronic data management and other issues,and carries out a comprehensive verification of the effectiveness of the operation of the quality management system and so on.Results National drug sampling and testing institutes should strengthen the overall quality management,according to the operation of the laboratory,combined with their respective risk characteristics,reagent management,standard substance management,instrument and facility management,electronic data management and other aspects of the risk of systematic sorting and the establishment of the risk alert function,the development of risk warning lists,and the implementation of the corresponding risk control strategy.Conclusion National drug sampling and testing institutes must strengthen the operation of the process of influencing factors in the effective control of the emphasis on the testing of the work of the key control points and continue to standardize and improve the inspection process of the quality system to ensure that the quality of the various activities in a controlled state.
