The discussion on the key points of drug research and development quality management from the perspective of registration inspection
YAN Ruo-xi
Abstract：Based on the consideration and analysis of the basic requirements of drug registration inspection,the study analyzes the major contents such as authenticity,consistency,commercialized production conditions for marketing,compliance of research and integrity,and data reliability,as well as the key points of pharmacological and toxicological research,drug clinical trial,pharmaceutical development and manufacturing site inspection.From the perspective of drug registration inspection,the key points of quality management in drug research and development are identified and discussed,including data management,document management,organization and personnel,change control,deviation management,corrective and preventive action,contract management,production management,facilities and equipment,material and sample management,quality control and quality risk management.This article provides reference for further improvement on the quality management of drug research and development.
Keywords：drug research and developmentquality management systemregistration inspection
Publication Date：2024-01-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 28-35 )