Discussion on aseptic assurance issues of biologics manufacturing enterprises in Jilin Province in recent years
10.13200/j.cnki.cjb.004671
- VernacularTitle:近年来吉林省生物制品生产企业无菌保障问题探讨
- Author:
Xifan YANG
1
Author Information
1. Center for Inspection of JLMPA, Changchun 130033, Jilin Province, China
- Publication Type:Journal Article
- Keywords:
Biologics;
On-site inspection;
Aseptic assurance;
Risk management
- From:
Chinese Journal of Biologicals
2026;39(03):370-373+384
- CountryChina
- Language:Chinese
-
Abstract:
During routine Good Manufacturing Practice(GMP) compliance supervision, periodic inspections based on risk control concepts have revealed gaps between the current practices of biologics manufacturers in Jilin Province and the latest domestic and international regulatory standards. These gaps span multiple areas, including facility and equipment design for aseptic product manufacturing, airflow pattern control, cleaning and disinfection practices, environmental monitoring, aseptic process simulation, and personnel gowning procedures. This paper compiles and analyzes these identified issues. Considering the inherent tendency of biological product components to support microbial growth, and based on recent regulatory updates alongside a statistical analysis of aseptic manufacturing deficiencies observed during GMP compliance inspections in Jilin's biologics sector, this paper discusses the future direction for improving aseptic assurance levels. The aim is to provide theoretical support for both future regulatory efforts and the enhancement of aseptic assurance capabilities within enterprises.
