| 薛晶,祁文娟,黄清泉.降低现行药品检验抽样量的可行性探讨[J].中国药事,2022,36(11):1234-1238 |
| 降低现行药品检验抽样量的可行性探讨 |
| Discussion on the Feasibility of Reducing the Sampling Quantity in Current Drug Inspections |
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| DOI：10.16153/j.1002-7777.2022.11.004 |
| 中文关键词: 药品检验 业务类别 抽样量 降低 可行性 |
| 英文关键词: drug inspections types sampling quantity reduce feasibility |
| 基金项目: |
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| 摘要点击次数: 499 |
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| 中文摘要: |
| 目的：解决目前药品检验工作中面临的因抽样量大导致留样管理负担过重的实际问题，为相关规章的修订提供参考。方法：通过研究现行相关规章对药品检验抽样量的要求，分析降低抽样量的必要性，探讨降低抽样量的可行性，提出降低抽样量的建议。结果：为科学合理地开展抽样，抽样量倍数， 检验用、复试用、复验用样品比例，全项检验所需样品量等应依据药品检验业务类别的不同做出相应的调整。结论：部分现行相关规章对药品检验抽样量的要求与目前的检验工作实际不符，亟待修订，以保证药品生产企业、使用者和药监药检机构三方的最大化利益。 |
| 英文摘要: |
| Objective: To solve the practical problem of excessive burden on sample retention management due to large sampling quantity in drug inspections, and provide a reference for the revision of relevant regulations. Methods: By investigating the requirements of current relevant regulations on the sampling quantity of drug inspections, the necessity of reducing the sampling quantity was analyzed, the feasibility of reducing the sampling quantity was discussed and some suggestions for reducing the sampling quantity were put forward. Results: To carry out sampling scientifically and reasonably, the multiple of sampling quantity, the proportion of samples for inspection, retrial and retest, and the sample quantity required for complete inspection should be adjusted according to different types of drug inspections. Conclusion: Some of the existing relevant regulations on the sampling quantity of drug inspections were inconsistent with the actual drug inspections work at present. It is urgent to revise those regulations to ensure the maximum interests of drug manufacturers, users and drug administration and drug inspection institutions. |
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