Risk analysis and countermeasures on responsibility-based GMP compliance inspection of high-risk drug manufacturing enterprises in Anhui Province
RUI Xue
YE Liuping
HU Shigao
Abstract：In order to ensure continued adherence of high-risk drug manufacturing enterprises to GMP,a statistical analysis was performed on the deficiencies identified during the responsibility-based GMP compliance inspections conducted in Anhui Province from 2021 to 2023.A total of 1 408 inspection defects were summarized,including 7 serious defects,88 major defects and 1 313 general defects,which were mainly in the aspects of quality control and quality assurance,document management,sterile drug appendices,etc.High-risk drugs manufacturing enterprises should implement the main responsibility,strengthen contamination control strategy,establish long-term training mechanism,strictly manage suppliers,improve confirmation and verification and enhance product quality review analysis to continuously improve high-risk drugs quality and safety.
Keywords：High-risk drugGMP inspectionRisk analysis
Publication Date：2024-10-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：6( 1029-1034 )