Inspection and risk analysis of post-market changes(change of production site)of drugs
HAN Ying
BAI Jianxue
LIU Rong
CHAI Fayong
DUAN Shutao
CAO Hongyan
ZHANG Jie
Abstract：Objective To understand the current situation of quality management regarding post-market changes(changes in production sites)of drugs in Shandong Province,identify the common defect issues in the inspection of produc-tion site changes,explore the main risk points existing in the on-site inspection of post-market changes,and provide refer-ences for enterprises to implement post-market changes more standardized.Methods The requirements of laws and regula-tions for post-market changes(changes in production sites)of drugs were summarized,and conducted a statistical analysis of the inspection defects of production site changes of drug enterprises in Shandong Province in 2024.Results and Conclu-sion The inspection defects of post-market changes(changes in production sites)of drugs mainly concentrate on aspects such as document management,quality control and quality assurance,confirmation and verification,institutions and personnel.It is recommended that enterprises should pay special attention to the above-mentioned defects when implementing post-market changes(changes in production sites),continuously improve and enhance them to ensure the continuous and effective operation of the quality management system.
Keywords：Post-market changeCompliance inspectionDefect itemsQuality risk
Publication Date：2025-09-30
Online Publishing Date：2025-10-30(First online date of this platform, not the publication date of the document)
Pages：5( 932-936 )