| 王翀,刘文,冯磊,朱炯,胡增峣.药品抽检的抽样常见问题分析与应对策略[J].中国药事,2023,(7):751-756 |
| 药品抽检的抽样常见问题分析与应对策略 |
| Analysis and Countermeasures of Common Sampling Problems of Drug Sampling and Testing |
| 投稿时间：2022-04-15 |
| DOI：10.16153/j.1002-7777.2023.07.003 |
| 中文关键词: 药品监管 抽样 检验 探索性研究 抽样量 有效期 质量评价 |
| 英文关键词: drug supervision sampling testing exploratory research sampling capacity expiration date quality evaluation |
| 基金项目: |
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| 中文摘要: |
| 目的：对药品抽检的抽样常见问题进行分析并提出相关建议，以期为提高药品抽检的抽样工作质量提供参考。方法：介绍药品抽检的抽样相关政策法规和抽样模式，以2016-2021年国家药品抽检不符合检验要求的样品为例，分析抽样中的常见问题，提出完善建议。结果：目前，抽样的常见问题包括品种错误、抽样环节错误、样品保护不当、样品重复、抽样量不足、资料信息有误、混批、剩余效期不足等情况。结论：抽样是药品抽检整个工作链条的上游环节，其工作质量对药品抽检成效具有重要影响。样品因不符合检验要求而被承检机构拒收，既浪费资源又不利于全面评价药品质量，发生拒收的主要原因在于抽样人员的知识技能欠缺和工作态度有待提高，需引起抽样单位的重视。建议加强对抽样人员的教育培训及考核，慎重拒收样品并对确需拒收的样品细化原因记录，探索建立拒收样品再利用机制。 |
| 英文摘要: |
| Objective: To provide references for improving the quality of sampling work in drug sampling and testing. Methods: The relevant sampling policies, regulations and sampling modes of drug sampling and testing were introduced, and the samples that did not meet the testing requirements in national drug sampling and testing from 2016 to 2021 were taken as an example to analyze the common problems in sampling, and suggestions for improvement were put forwarded. Results: At present, the common problems in sampling included variety errors, sampling link errors, improper sample protection, duplicate samples, insufficient samples quantity, incorrect data information, mixed batches, insuffi cient expiration date, etc. Conclusion: Sampling was an upstream link in the entire work chain of drug sampling and testing. The quality of its work had an important impact on the effectiveness of drug sampling and testing. These samples were rejected by the testing institutes because they did not meet the testing requirements, which was a waste of resources and not conducive to a comprehensive evaluation of drug quality. The main reason was the lack of knowledge and skills of the samplers, and their work attitude needed to be improved. The sampling unit should pay attention to it. Therefore, it is suggested to strengthen the education, training and assessment of samplers, reject samples with caution and record detailed reasons for samples that really need to be rejected, and explore to establish a re-use mechanism for rejected samples. |
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