药品微生物控制体系建设现状与展望

Current Situation and the Trend in Pharmaceutical Microbial Control System

药品微生物控制是药品安全性保障的重要措施。本文通过对中国药典2020年版增修订重点工作的回顾,阐述中国药品微生物控制体系的发展过程。药品微生物污染控制体系包括药品微生物实验室建设、药品微生物控制标准体系建设和中药微生物控制体系建设3个部分。中药微生物控制体系建设作为中药国际化的重要组成部分,目前已经取得了实质性的进展,提升业界对微生物污染风险的认识是关键;而药品微生物控制标准体系的建设围绕着推进微生物过程控制理念的实施,促使企业成为微生物污染控制的主体开展;其中,全面提升企业药品微生物实验室的能力与管理水平是关键。

The pharmaceutical microbial control plays an important part in drug safety guarantee.In this paper,the construction progress of pharmaceutical microbial contamination control system in China is described by reviewing the key works of addition and revision for Chinese Pharmacopoeia 2020 Edition.The pharmaceutical microbial control system includes three parts:construction of pharmaceutical microbiology laboratory,construction of specification on pharmaceutical microbial control,and construction of control system for microbial contamination of traditional Chinese medicine(TCM).As an important part of internationalization of TCM,control for TCM microbial contamination has made substantial progress in present.To enhance the manufacture awareness of the risk of TCM microbial contamination is the key.The implementation of process microbial control is the main works in the specification construction,which makes manufactures to be responsible for the pharmaceutical microbial control.It is the key to improve the ability and management level of manufactures’pharmaceutical microbiology laboratories for achieving the target.