摘要
Abstract
Objective To master the drug inspection capacity of regional drug inspection institutions in Shanghai,and construct a capacity evaluation and guidance system for them.Methods A questionnaire survey was conducted among eight regional food and drug inspection institutes/centers(refered to as regional institutes)in the city.Taking the Class C(″routine capacity″)standard of the Guiding Principles for Capacity Building of Pharmaceutical Testing Institutions(refered to as Guiding Principles)as the evaluation basis,a quantitative scoring guideline was formulated to score and grade the capacity of each regional institute,and a targeted guidance plan was drafted.Results The eight regional institutes were generally weak in basic indicators such as institution,personnel(staffing quota,education background,professional title),site,instrument and equipment,information construction,as well as technical indicators such as routine inspection items/parameters,capacity testing,service indicators included inspection quality,inspection efficiency,risk testing and innovation indicators included scientific and technological projects,paper publication,standard formulation and revision.The capacity evaluation results of regional institutes showed one institute at level Ⅱ,Grade 1,two institutes at level Ⅱ,Grade 2,three institutes at level Ⅲ,Grade 1,and two institutes at level Ⅲ,Grade 2.A guidance mechanism for personnel training and quality supervision was constructed.Conclusion The superior supervision and technical guidance departments of regional institutes should closely combine the survey and evaluation results to carry out precise guidance for regional institutes,while also pooling multi-party forces to jointly promote the capacity building and development of regional institutes.关键词
药品检验机构/能力建设/调研/上海Key words
drug testing institution/capacity building/survey/Shanghai分类
医药卫生
