国家药品抽检中复验改判情况分析与建议

Analysis and Suggestions on Re-test Judgment Changes in National Drug Sampling and Testing

目的 为提高药品抽检中的不符合规定药品的检验准确性提供参考。方法 梳理药品复验相关政策法规、国家药品抽检中的复验结论改判情况,分析产生复验改判的原因,为降低复验改判率提出建议。结果 近6年来,国家药品抽检中复验结论改判现象较为常见,整体复验改判率高达13.97%,主要原因包括样品质量不均、不同检验机构之间的能力水平差异,以及不同检验人员的主观判断差异等。结论 建议相关单位规范抽样、规范检验、纳入考核,以此促进工作质量提高和复验改判率降低。

OBJECTIVE To provide reference for improving the test accuracy of drugs that do not comply with specifications in drug sampling and testing. METHODS Analyzed the relevant policies and regulations for drug re-test and the reasons for re-test judgment change in national drug sampling and testing, and made suggestions for reducing the rate of re-test judgment change. RESULTS In the past 6 years, the re-test judgment change phenomenon had been common in national drug sampling and testing, and the overall rate of re-test judgment rate was as high as 13.97%. The main reasons included uneven sample quality, the difference in ability levels between different test institutes and the difference in subjective judgments of different analysts. CONCLUSION It is suggested to standardize sampling, testing and to incorporate assessments to improve work quality and reduce the rate of re-test judgment change.