| 柴发永,柏建学,刁兴彬,朱海升.药品清洁残留分析方法有关概念及影响因素的探讨[J].中国药事,2021,35(7):814-821 |
| 药品清洁残留分析方法有关概念及影响因素的探讨 |
| Discussion on the Concepts and Influencing Factors of Recovery Rate of Cleaning Residue Analysis Method for Pharmaceuticals |
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| DOI：10.16153/j.1002-7777.2021.07.013 |
| 中文关键词: 清洁验证 回收率 检验方法 取样方法 分析方法 擦拭取样 |
| 英文关键词: cleaning verification recovery rate inspection method sampling method analysis method swab sampling |
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| 摘要点击次数: 646 |
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| 中文摘要: |
| 目的：以回收率为切入点，研究药品清洁验证中清洁残留分析方法的有关概念和做法，为药品生产企业在清洁验证时对残留物分析方法学的研究提供参考。方法：通过查阅有关文献，比较归纳药品清洁残留物分析方法的有关概念和做法，研究影响分析方法回收率的各种因素，在概念解读和对文献分析的基础上提出针对性建议。结果：对在中国知网检索到的2015-2020年的关于清洁验证残留物分析方法的21篇文献进行了分类，分别对检验方法回收率、取样方法回收率以及同时对二者进行研究的文献进行了分析，并着重对取样方法回收率研究中擦拭取样操作的过程及重点环节进行了分析，进一步分析讨论了检验方法回收率和取样方法回收率2个概念。结论：在对清洁验证残留物分析方法的回收率进行研究时，应同时考虑对清洁残留的取样操作和对残留物溶液的分析，建议以分析方法回收率的概念进行方法学考察。在交叉污染风险较大的情况下，回收率的研究是必要的；但在交叉污染风险相对较小时，回收率的研究意义不大。微生物残留的回收率研究，应结合产品和设备情形根据风险评估来决定验证的深度和广度。 |
| 英文摘要: |
| Objective: Taking the recovery rate as the breakthrough point, the related concepts and practices of cleaning residue analysis method in drug cleaning verification were studied, which could provide a reference for manufacturers to carry out the research on residue analysis methodology in drug cleaning verification. Methods: By referring to relevant literature, the concepts and practices of analytical methods for cleaning residues of drugs were compared and summarized, various factors affecting the recovery rate of analytical methods were studied, and targeted suggestions on the basis of concept interpretation and literature analysis were put forward. Results: 21 papers on the analysis method of clean verification residues retrieved by CNKI from 2015 to 2020 were classified. The recovery rate of inspection method, and sampling method and the literature on the study of both methods were analyzed respectively. The process and key links of swab sampling operation in the recovery rate of sampling method was analyzed, and two concepts of recovery rate of inspection method and analysis method were further analyzed and discussed. Conclusions: In the study of the recovery rate of residue analysis methodfor cleaning validation, the sampling operation of cleaning residue and the analysis of residue solution should be considered simultaneously. It is suggested that the concept of analytical method recovery rate should be used for methodological investigation. In the case of high risk of cross contamination, the study of recovery rate was necessary. However, when the cross-contamination risk was relatively small, the research on recovery rate was of little significance. In the study of microbial residue recovery rate, the depth and breadth of verification should be determined according to the risk assessment of products and equipment. |
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