Discussion on the Concepts and Influencing Factors of Recovery Rate of Cleaning Residue Analysis Method for Pharmaceuticals

doi:10.16153/j.1002-7777.2021.07.013

Chinese Pharmaceutical Affairs ›› 2021, Vol. 35 ›› Issue (7) : 814-821. DOI: 10.16153/j.1002-7777.2021.07.013

Chai Fayong¹, Bai Jianxue¹, Diao Xingbin¹, Zhu Haisheng²

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Abstract

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.

Key words

cleaning verification； recovery rate； inspection method； sampling method； analysis method； swab sampling

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Chai Fayong, Bai Jianxue, Diao Xingbin, Zhu Haisheng. Discussion on the Concepts and Influencing Factors of Recovery Rate of Cleaning Residue Analysis Method for Pharmaceuticals[J]. Chinese Pharmaceutical Affairs, 2021, 35(7): 814-821 https://doi.org/10.16153/j.1002-7777.2021.07.013

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