Objective: To evaluate the processing ability of identification,tracing and abnormal occurs in drug manufactures by the proficiency testing for microbiological identification and traceability in Shandong Province. Methods: The proficiency test was derived from an event of drug microbial contamination, and samples including contaminated products group and production group were designed to evaluate the testing and tracing competence of 264 participants from those aspects of drug control, identification, genetic comparison and traceability. The contaminated products group was composed of five simulated samples including one positive sample which included Enterobacter cloacae and Staphylococcus aureus, and four negative samples which were sterile. The production group was composed of five simulated samples including four positive samples and one negative sample, but each of the four positive sample included only one strain of Enterobacter cloacae, Staphylococcus aureus, Staphylococous epidemidis and Pseudomons aeruginosa, respectively. Results: 259 participants reported their results. The rate of unqualified, qualified, good and excellent results were 3.5%, 49.8%, 46.7% and 0, respectively. But four results reported phylogenetic tree based on 16S rRNA gene without genetic comparison at the strain level. The unqualified result indicated inaccurate inspection of positive and negative sample. The qualified result indicated accurate inspection but inaccurate species identification or not. The good result showed accurate species identification without effective tracing analysis. Conclusion: The ability of most drug manufactures to contaminant microorganisms testing are acceptable. But the ability of microbiological identification and traceability, the precise judgement and the effective measures to an emergency of microbial contamination in drugs remain to be strengthened.
XU Xiao-jie, FENG Dan-yang, REN Li-hong, MENG Xiao-li, SHEN Zhen, XING Sheng, DING Bo
. Results and analysis of proficiency testing for microbiological identification and traceability in pharmaceuticals[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(3)
: 427
-433
.
DOI: 10.16155/j.0254-1793.2024.03.07
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