福建省药品上市许可持有人委托生产检查现状分析OACSTPCD

Objective To provide a reference for improving the supervision and management of marketing authorization holders(MAHs)quality system.Methods The results of inspection for commission production of MAHs in Fujian were summarized,including the basic information,distribution of MAHs and defects found in the inspection.The common problems found in the inspection were analyzed,the challenges of inspection for commission production of MAHs were explored,and its optimization direction was look forward to.Results A total of 145 applications for various drug production licenses were accepted by the Fujian Drug Inspection Center in 2021 and 2022,of which 62 involved commission production(42.76%).A total of 32 on-site inspections and 24 document reviews were conducted on 24 MAHs commissioning production in nine cities in Fujian,involving 74 varieties of drugs.A total of 204 defective items were found,including 19 main defective items and 185 general defective items,mainly involving quality control,quality assurance and document management.The common problems found the inspection included the inability of the document system established by MAHs to effectively connect with commission production,incomplete pharmacovigilance system,imperfect quality control and quality assurance system,and insufficient qualifications and capabilities of MAHs with pure B-certificate.The challenges of inspection included the implementation of cross-provincial inspections,risk identification of changes after drug launched and rational application of new inspection technologies.Conclusion It is suggested that MAHs should strengthen quality awareness,and actively play the role of the person in charge for the whole lifecycle of drugs.Inspection agencies should optimize the inspection methods,accelerate the interconnection of regulatory information,unify the inspection standards,and improve the inspection efficiency.