国际微生物污染相关药品召回回顾分析(2013—2019)

Review and Analysis of International Microbial Contamination-related Drug Recalls from 2013 to 2019

关键词:  药品召回  微生物污染  无菌产品  非无菌产品

Key words:  drug recall  microbiological contamination  sterile product  non-sterile products

摘要:

目的 总结微生物污染引发的药品召回事件，以期为我国药品监管工作提供参考，为药企生产质控流程的优化、微生物污染溯源和控制提供理论依据。方法 基于2013-2019年中国、美国、澳大利亚、日本和新加坡药品召回报告，分析微生物污染相关召回药品类型、召回次数和污染微生物种类。结果 在2013-2019年间，共计11 074次药品召回事件中，有428次召回与微生物污染相关，其中仅有176次（41.12%）明确鉴定物种；微生物污染相关药品召回中，无菌药物召回66次，非无菌药物召回360次。微生物污染的无菌药品召回以注射剂为主，有51次，占无菌药品召回的77.27%；非无菌药品的微生物污染召回中，洋葱伯克霍尔德菌（Burkholderia cepacia）污染居于首位（105次），其次是沙门氏菌（Salmonella spp.）（28次）。结论 无论对无菌产品还是非无菌产品，微生物的种类信息对污染溯源和制定正确消杀方案或者工艺改进至关重要，同时污染微生物种类的总结和回顾，可为生产企业、监管部门等实施有效的微生物控制提供参考信息。

Abstract:

OBJECTIVE To summarize the drug recall caused by microbial pollution, with a view to providing reference for the drug supervision work in China, and providing theoretical basis for the optimization of the quality control process, the traceability and control of microbial pollution in the production of pharmaceutical enterprises. METHODS Based on drug recall reports at the year of 2013-2019 from the United States, Australia, Japan and Singapore, the types of recalled drugs, the number of recalls and the types of microorganisms associated with microbial contamination was analyzed. RESULTS From 2013 to 2019, there were 428 recalls related to microbial contamination among the 11 074 drug recalls, of which only 176 (41.12%) were identified species clearly. In the recall of microbial contamination-related drugs, sterile drugs were recalled 66 times, and non-sterile drugs were recalled 360 times. Recalls of sterile drugs contaminated with microorganisms were mainly injections(51 times), accounting for 77.27% of the recalls of sterile drugs. In the recall of microbial contamination of non-sterile drugs, Burkholderia cepacia ranked first(105 times), followed by Salmonella spp.(28 times). CONCLUSION Whether for sterile products or non-sterile products, the information on the types of microorganism is essential for the traceability of pollution sources and the formulation of correct elimination programs or process improvement. At the same time, the summary and review of the types of contaminated microorganisms can provide reference information for multi-party cooperation such as the production enterprises and supervision to implement effective microbial control.