Analysis and Discussion of Typical Problems in On-Site Inspection of Biochemical Pharmaceutical Manufacturers in China
Objective To provide a reference for improving the quality management capability of biochemical pharmaceutical manufacturers in China.Methods The relevant regulatory requirements at home and abroad were summarized.After the implementation of the Biochemical Medicinal Products Appendix of the Good Manufacturing Practice(Revised in 2010),the tracking inspections and 11 invited observation inspections for the implementation of Good Manufacturing Practice(GMP)in 25 biochemical pharmaceutical manufacturers in China(excluding Hong Kong,Macao,Taiwan)conducted by the Center for Food and Drug Inspection of NMPA(hereinafter referred to as the Inspection Center)from September 2017 to August 2022 were reviewed,and the defects were analyzed.Results A total of 302 defects were found during the tracking inspection,including 0 serious defect,26 major defects and 276 general defects.During the observation inspections,there was no defect item in the two raw material inspections;the defect grade was not defined in three on-site inspections;55 defects were reported on-site in the other six inspections,including 1 serious defect,15 major defects and 39 general defects.Tracking inspection showed that the biochemical medicinal products were defective in the quality control and quality assurance,document management,sterile drugs(appendix),confirmation and verification and its appendix.Observation inspection showed that there were the most problems in quality control and quality assurance,followed by confirmation and verification;the problems such as workshop equipment not suitable for the intended use and inadequate maintenance of factory facilities were more than those in tracking inspections.Conclusion It is recommended that biochemical pharmaceutical manufacturers in China should further improve production quality management and product full-lifecycle management starting from raw materials based on actual status;drug regulatory departments should improve the inspection file management of inspected units and strengthen the application of inspection results,adjust the frequency of sampling and daily regulation,and rationally formulate inspection guidelines or inspection memorandum lists for biochemical medicinal products.
biochemical medicinal productinspection defecton-site inspection of productiontracking inspectionobservation inspection
万方数据
维普
