Discussion on the Risk Control of Post-Marketing Drug Changes
OBJECTIVE In accordance with drug regulatory requirements,this article studiedand exploredhow to conduct risk control when drugs changed after post-marketing,to providereference for risk management of changes in drug production enterprises.METHODS Conducted risk analysis and developed control measures around multi-ple aspects such as human,machine,material,method,environment,and pharmaceutical regulations.RESULTS Af-ter risk analysis,the measures such as personnel training,instrument and equipment validation,document revision,production environment validation,and reporting changes in accordance with pharmaceutical regulations have been formulated.CONCLUSION Drug marketing license holders and manufacturing enterprises are the responsible sub-jects of post-marketing change management of drugs,and should establish a Change control system to classify,assess risks,develop risk control measures,and conduct research and verification to minimize drug quality risks.
Changesafter drug post-marketingChange riskRisk Management
万方数据
维普
