非无菌药品的微生物质量考虑

Considerations of microbiological quality for non-sterile drugs

结合美国FDA 2021年9月发布的指南草案“Microbiological Quality Considerations in Non-sterile Drug Manufacturing”(非无菌药品生产中的微生物质量考量)对非无菌药品微生物质量属性的要求,重点对影响非无菌药品微生物质量属性的风险点进行讨论,以协助生产商更好地控制非无菌药品的微生物质量,减少因微生物污染而引起的药品召回及不良反应事件。此外,对基于风险评估的微生物检查计划进行了讨论,并提供了相关建议。最后,探讨了水性制剂中的洋葱伯克霍尔德菌(Bcc菌)污染及控制策略。

Combined with the guideline draft Microbiological Quality Considerations in Non-sterile Drug Manufacturing issued by FDA in September 2021, the risks affecting the microbial quality attributes of non-sterile drugs are discussed, so as to help manufacturers better control the microbial quality of non-sterile drugs and reduce drug recall and adverse reaction events caused by microbial pollution. In addition, this paper discusses the microbial detection plan based on risk assessment in order to provide relevant suggestions. Finally, the contamination and control strategy of Burkholderia cepacia(Bcc) in aqueous preparations are discussed.