Analysis of the problems in standardized production of medical oxygen production enterprises in Guizhou Province
ZHOU Minghao
ZHANG Hongman
Abstract：Objective:To review the implementation of the Good Manufacturing Practice(GMP)revised in 2010 by medical oxygen production enterprises in Guizhou Province in the past two years and the main existing problems,and to explore new models for compliant production of medical oxygen production enterprises and new methods for scientific supervision by regulatory authorities.Methods:By summarizing and analyzing the on-site inspections of drug production in 11 medical oxygen production enterprises in the province in the past two years,recommendations were made based on the existing problems.Results:Medical oxygen production enterprises in the province still needed further improvement in implementing GMP medical oxygen appendices,quality control and assurance,document management,equipment,institutions and personnel,and production management in the past two years.Conclusion:It is recommended that enterprises take effective corrective and preventive measures based on actual problems.In addition,regulatory authorities should adopt a forward-looking or retrospective approach to scientifically supervise medical oxygen production enterprises to ensure the safety and compliance of medical oxygen products already on the market.
Keywords：medical oxygenGood Manufacturing Practiceexisting problemsprospective and retrospectivescientific supervision
Publication Date：2025-02-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 20-23 )