Research on the Management of Changes in Drug Manufacturing Sites and Analysis of Common Issues in the Evaluation of Chemical Preparations
As a special commodity,the quality of drugs is closely intertwined with the sources of raw materials,production processes,control conditions,and the quality management level of enterprises.Changes in the drug manufacturing site,a common occurrence after a drug has been marketed,are often accompanied by changes in the aforementioned elements,which bring varying degrees of impact and risk to drug quality.Strengthening the management and research of drug manufacturing site changes to ensure the safety,efficacy,and controllable quality of drugs post-change is a crucial responsibility of the Marketing Authorization Holder and regulatory bodies.This article focuses on chemical drugs and,from the perspective of reviewers,analyzes the regulatory background and common issues encountered in the current change of drug manufacturing sites in China.It also proposes corresponding management suggestions and research ideas.
chemical drugpreparationmanufacturing site changeevaluationqualityregulation
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