Asian Journal Of Social Pharmacy

Abstract: Objective To provide some references and suggestions for promoting the healthy development of pharmaceutical wholesale enterprises, improving the scientific supervision level of the drug regulatory department and ensuring the quality of drugs in the circulation. Methods Retrieving the items on the official websites of the national and provincial drug regulatory departments from 2017 to 2019 that didn’t meet the requirements of the 2016 edition of the Good Supplying Practice in pharmaceutical wholesale enterprises under various inspections, the defective items were summarized and analyzed, and further study of the changes of defective items was conducted. Results and Conclusion 908 pharmaceutical wholesale enterprises had definite defective items, and 218 items violated the Guidelines for On-site Inspection of the Good Supplying Practice, with a cumulative frequency of 3 874 defects. Defective items with high-frequency mainly occurred in storage and maintenance, facilities and equipment, personnel and training, general rules and sales. The average defect frequency in each pharmaceutical wholesale enterprises increased year by year, but the proportion of serious defective items decreased significantly. It is recommended that based on improving drug quality, pharmaceutical wholesale enterprises should strengthen personnel training to enhance their awareness of quality responsibility. Besides, the drug regulatory department should increase inspection and crackdown on illegal business operations and the deception of pharmaceutical wholesale enterprises.

Key words: pharmaceutical wholesale enterprise, good supplying practice, defective item