Non-sterile Generic Drug Materials Pathogens Characteristics

[摘要] Pharmaceutical products are classified as either sterile or non-sterile in terms of microbiology. Non-sterile drugs must meet themicrobiological purity criteria outlined in pharmacopoeial monographs. Pharmacopoeial studies are designed to ensure that the medicinalproduct is both therapeutically effective and safe for the patient. The results of microbiological purity tests performed prior to productmarketing were included in the analysis. A total of 1285 samples of non-sterile drugs manufactured by various pharmaceutical plants inPoland were studied. The microbiological quality of drugs was evaluated using criteria from the European Pharmacopoeia (EP). Anexamination of the test results revealed that the percentage of non-compliant samples was 1.87%. The groups of drugs that did not meet EPrequirements the most frequently were those containing natural raw materials (5.7%). The studied drug samples did not meet the EP criteria,exceeded the maximum allowable microbiological count limits, and contained microbes whose presence is prohibited. Excessive levels ofthe maximum acceptable fungal count (n=12) and the maximum acceptable aerobic microbial count (n=10) were the most common noncompliances.

[学科分类] 药理学