目的 进一步提高药品应急检验应对能力。方法 采用回顾性研究的方法,对江苏省食品药品监督检验研究院2019年亚硝胺类基因毒性杂质专项应急检验全过程工作进行梳理。结果 总结了专项应急检验中各环节的处置流程、管理特点和难点,提炼处置经验教训。结论 应急检验工作是对检验机构应急响应能力、技术实力的全面考验。需从事前、事中和事后制订系统的应对策略,构建完善的药品应急检验管理体系。
Abstract
OBJECTIVE To improve the emergency response ability to drug inspections. METHODS This paper reviews and summarizes the special emergency test for Nitrosamine genotoxic impurities in 2019, and analyzes the characteristics and difficulties on emergency inspection management. RESULTS The work of emergency inspection is a comprehensive test of the emergency response ability and technical strength. CONCLUSION It is necessary to formulate systematic coping strategies before, during and after the event, and to build a perfect drug emergency inspection and management system.
关键词
药品检验 /
应急检验 /
管理体系 /
基因毒性 /
亚硝酸类 /
杂质
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Key words
drug inspection /
emergency inspection /
management system /
genotoxic /
nitrous acid /
impurity
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中图分类号：
R917
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参考文献
[1] FRITZ S, MARTINA K, MONA A T, et al. The contamination of valsartan and other sartans, part 1: new findings[J]. J Pharm Biomed Anal, 2019, 172: 395-405.
[2] LIM H H, OH Y S, SHIN H S. Determination of N-nitrosodimethylamine and N-nitrosomethylethylamine in drug substances and products of sartans, metformin and ranitidine by precipitation and solid phase extraction and gas chromatography-tandem mass spectrometry[J]. J Pharm Biomed Anal, 2020, 189: 113460.
[3] SHAIK K M, SARMAH B, WADEKAR G S, et al. Regulatory updates and analytical methodologies for nitrosamine impurities detection in sartans, ranitidine, nizatidine, and metformin along with sample preparation techniques[J]. Crit Rev Anal Chem, 2020. DOI:10.1080/10408347.2020.1788375.
[4] US. Food and Drug Administration. Statement alerting patients and health care professionals of NDMA found in samples of ranitidine[EB/OL]. [2019-09-13]. https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine.
[5] European Medicines Agency. EMA to review ranitidine medicines following detection of NDMA[EB/OL]. [2019-09-13]. https://www.ema.europa.eu/en/news/ema-review-ranitidine-medicines-following-detection-ndma.
[6] US. Food and Drug Administration. FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity[EB/OL]. [2019-09-24]. https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-sandoz-ranitidine-capsules-following-detection-impurity.
[7] US. Food and Drug Administration. FDA alerts health care professionals and patients to voluntary recall of ranitidine medicines[EB/OL]. [2019-09-26]. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine#5f1d0cce71e71.
[8] Singapore Health Sciences Authority. HSA Recalls Three out of 46 Metformin Medicines[EB/OL]. [2019-12-04]. https://www.hsa.gov.sg/announcements/news/hsa-recalls-three-out-of-46-metformin-medicines.
[9] US. Food and Drug Administration. Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS) Method for the Determination of NDMA in Ranitidine Drug Substance and Drug Product[EB/OL]. [2019-09-13]. https://www.fda.gov/media/130801/download.
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