Investigation and Analysis on Quality Management of MAH Only Commissioning Production
Objective:The number of marketing authorization holders(MAHs)only commissioning production is constantly increasing after the implementation of the MAH system,which brings risks.The aim of the research is to provide workable proposals for the quality management of MAH and drug regulatory anthorities.Methods:Taking the enterprises in Jiangsu province as the research object,the quality management status of MAH only commissioning drug production was investigated,the existing problems in quality management were found,the causes were analyzed and suggestions were put forward.Results:There were some unique problems such as inadequate implementation of quality and safety main responsibilities,insufficient quality and risk control capabilities in the quality management system of the MAH,which were mainly caused by weak quality awareness,difficulty cooperation and matching,weak subject status,and difficulty in quality system connection.Conclusion:MAH only commissioning drugs should actively fulfill the main responsibicity of quality and safety,and drug regulatory authorities can take measures such as inovating regulatory methods and strengthening adminiatrative guidance to continuously improve the quality management system and optimize regulatory measures to ensure drug quality and drug safety.
marketing authorization holdercommission productionquality managementcurrent situation investigationanalysis and suggestion
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