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.
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.
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.
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.
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.
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.
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.
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.
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.
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.