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

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.