药品微生物分子生物学分析专栏

Special Column for Molecular Biology of Pharmaceutical Microbiology

药品中污染微生物(microorganism)是影响产品质量和用药安全的重要因素,会对患者尤其是免疫力低下人群造成严重威胁。因此,GMP、药典和相关技术指南等都在不断明确和提高对于药品及其生产过程中微生物的检测、鉴定和溯源要求,以加强药品生产过程控制,提升药品质量,降低用药风险。

Contaminated microorganisms in medicines are significant factor affecting the quality of products and safety of medication.There will be a serious threat to patients,especially immunocompromised patients.Therefore,GMP,pharmacopoeia and other related technical guidelines have been constantly clarifying and improving the requirements for detection,identification and traceability of microorganisms in medicines and their production processes,in order to strengthen the control of production process,improve the quality of medicines and reduce the risk of medication.