Analysis and Suggestions on the Problems Regarding the Full Process Production Site Supervision of the Entrusted Enterprise by Marketing Authorization Holder
Objective:To explore the coping strategy to the full process production site supervision of the entrusted enterprise by Marketing Authorization Holder(MAH)under the new situations.Methods:By combing the extension inspectd of entrusted production enterprises outside the province by pharmaceutical contract manufacture(hereinafter referred to as the B-certificate)MAH in Guangdong Province,the problems and reasons for the full process production site supervision of the entrusted enterprise were deeply discussed,and the corresponding improvement suggestions were put forward,according to the quality management of drug production and the relevant provisions on strengthening the management of holders after listing.Results:After combing the status of entrusted production extension inspections,it was found that three aspects problems of holders about key personnel configuration,understanding of the entire process supervision and production risk assessment,which were manifested in the lack of rich work experience of personnel,the lack of rigorous supervision methods throughout the entire process,and the incomplete assessment of production risks.Conclusion:The B-certificate MAH should focus on key personnel to fulfill their main responsibilities,improve management processes to standardize supervision behavior,strengthen risk assessment to identify safety hazards,so as to ensure the number and qualifications of key personnel match the production scale,form a closed-loop quality management system for the entire production process,carry out comprehensive and precise risk assessment,and firmly establish awareness of drug quality and safety.
marketing authorization holderentrusted enterprisethe full process production site supervisionmain issuesanalysis suggestions
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