Current Situation and the Trend in Pharmaceutical Microbial Control System

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.