摘要
Abstract
Objective To improve the quality of traditional Chinese herbal pieces.Methods A retrospective analysis was conducted on the defect items found in the conformity inspection of the Good Manufacturing Practice(GMP)of 39 Chinese herbal pieces manufacturers in Anhui Province in 2022 to summarize the common problems,and targeted suggestions were put forward.Results A total of 439 inspection defects were found,including six serious defects,26 major defects,and 407 general defects,mainly concentrated in quality control and quality assurance(23.01%),document management(18.00%),confirmation and verification(11.39%),Appendix of Chinese herbal pieces(11.16%),organizations and personnel(9.79%),equipment(6.61%),plant and facilities(5.47%),production management(5.01%),materials and products(3.87%),and other aspects.Conclusion Chinese herbal pieces manufacturers should enhance quality awareness,strengthen personnel training,improve inspection capabilities,standardize document management,and improve equipment verification to improve the quality management system of drug production.Drug regulatory authorities should improve the construction of the supervision system to form the supervision force,and realize intelligent supervision by constructing the information-based traceability system of Chinese herbal pieces production,in order to ensure the quality of Chinese herbal pieces.关键词
中药饮片生产企业/《药品生产质量管理规范》符合性检查/缺陷分布/安徽省Key words
Chinese herbal pieces manufacturers/GMP conformity inspection/defect distribution/Anhui Province分类
医药卫生
