我国药品批发企业监督检查判定标准探索OACSTPCD

Objective To provide a reference for improving the regulatory capacity of drug regulatory departments.Methods Based on system research,literature review and regulatory experience,the problems in the existing criteria for supervision and inspection of pharmaceutical trading enterprises in China and the cases that on-site inspection conclusions did not meet the requirements were analyzed,and the improvement suggestions were proposed.Results There were multiple problems in the existing supervision and inspection criteria,such as the inapplicability of supervision,certification and inspection judgments based on the Guidelines for Drug GSP On-Site Inspection(Revised Draft,referred to as the Guidelines)and the lack of guidance in the existing Measures for the Administration of Drug Inspection(Trial).In addition to the 10 serious defective items mentioned in the Guidelines,a total of 12 cases that might not meet the requirements were proposed,involving personnel and training,computer systems,storage and maintenance,transportation and distribution.Conclusion It is suggested that inspection agencies and law-enforcement departments should jointly formulate the criteria for supervision and inspection,and establish a quality management system for supervision and inspection;the regulatory departments should formulate scientific and effective criteria,unify the judgment of inspectors to promote the efficient supervision and inspection of pharmaceutical wholesale enterprises.