Tyski Stefan, Burza Magdalena, Laudy Agnieszka Ewa
Department of Pharmaceutical Microbiology and Laboratory Diagnostic, National Medicines Institute, 00-725 Warsaw, Poland.
Department of Pharmaceutical Microbiology and Bioanalysis, Medical University of Warsaw, 02-097 Warsaw, Poland.
Pharmaceuticals (Basel). 2025 Jun 23;18(7):946. doi: 10.3390/ph18070946.
Medicinal products available on the market should be characterised by therapeutic efficacy, high quality, and safety for patients. They must either be sterile or comply with the appropriate pharmacopoeial microbiological purity requirements. Pharmacopoeial monographs related to microbiological tests of drug quality were also referenced. Despite stringent regulations governing pharmaceutical production, irregularities in the microbiological quality of drugs still occur. These are monitored by relevant agencies, which may order the recall of defective product batches from the market. However, in recent years, numerous cases of microbiological contamination in drugs and drug-related infections have been reported. Both isolated incidents and larger outbreaks or epidemics linked to contaminated medicines have been documented. Various microorganisms, including Gram-negative and Gram-positive bacteria, anaerobes, and yeast-like and mould fungi, have been identified in medicinal products or in patients affected by contaminated drugs. Ensuring the appropriate purity or sterility of pharmaceutical raw materials; maintaining cleanliness in the manufacturing environment, facilities, and equipment; and adhering to hygiene protocols and Good Manufacturing Practice regulations are essential for the production of safe and high-quality medicinal products. The aim of this study is to collect and compile information on the microbiological quality of drugs available on the market, with particular attention to identified irregularities, objectionable microorganisms isolated from medicinal products, and drug-related infections.
市场上的药品应具备治疗功效、高质量以及对患者的安全性。它们必须无菌或符合相应药典的微生物纯度要求。还参考了与药品质量微生物检测相关的药典专论。尽管药品生产有严格的规定，但药品微生物质量方面的违规行为仍有发生。相关机构对此进行监测，可能会下令从市场召回有缺陷的产品批次。然而，近年来，已报告了许多药品微生物污染及与药品相关感染的案例。已记录了孤立事件以及与受污染药品相关的较大规模暴发或流行。在药品中或受污染药品影响的患者体内已鉴定出各种微生物，包括革兰氏阴性菌和革兰氏阳性菌、厌氧菌以及酵母样真菌和霉菌。确保药品原材料的适当纯度或无菌性；保持生产环境、设施和设备的清洁；以及遵守卫生规程和良好生产规范对于生产安全和高质量的药品至关重要。本研究的目的是收集和汇编市场上药品微生物质量的信息，特别关注已识别的违规行为、从药品中分离出的有害微生物以及与药品相关的感染。
