摘要
Abstract
OBJECTIVE:To provide reference in the adaptation of the new-version Good Supply Practice(GSP)in pharmaceu-tical wholesale enterprises in Shandong province. METHODS:The research sample was got by 160(total 177 times)pharmaceuti-cal wholesale enterprises which completed for the GSP certification in Shandong Province from Mar. to Dec. in 2015. According to the 15 chapters,258 items were classified serious items (6 items),important items (107 items),general items (145 items) in GSP Site Inspection Guidelines(hereinafter referred to as Guidelines),a summary was conducted for the contents and the frequen-cies of the items in each chapter,and one defective item(high-frequency item)in more than 10% enterprises;the reasons of im-portant defective items and high-frequency items were analyzed in aspects of objective conditions and subjective factors,then pre-ventative measures were presented. RESULTS & CONCLUSIONS:Totally 120 defective items were found,involving 1 494 times, including 0 serious item(0 times),5 important items(5 times),115 general items(1 489 times),mostly concentrated in facility and equipment (225 times),quality management system document (218 times),storage and conversation (168 times) and staff training(159 times),and 29 high-frequency items(999 times),which were general items. In the 5 important and 29 high-frequen-cy items,there were 5(146 times)caused by objective conditions(such as lack of hardware);and 29(853 times)caused by sub-jective factors. To solve the defective items caused by objective conditions(such as staff insufficient understanding for GSP),it is suggested that staff in pharmaceutical wholesale enterprises should find the problems,and give their feedback to management in time;to solve the defective items caused by subjective factors,it is suggested that enterprises’leaders should increase their quality awareness,emphasize talents of quality management,and upgrade employees’attainment.关键词
山东省/药品经营质量管理规范/缺陷项目/防范措施Key words
Shandong province/Good Supply Practice/Defective items/Preventative measure分类
医药卫生
