Abstract：OBJECTIVE To provide reference for domestic pharmaceutical enterprises to carry out relevantchange research and quality management, based on analyzing the problems and interpretating the policy in the process of specific production site change. METHODS This paper deeply interprets a series of change technical guidelines issued in recent years, and summarized the common problems in the change of chemical preparations site. RESULTS The process change of listed drugs runs through the whole life cycle of drug listing. With the progress of science and technology, new scientific and technological achievements such as new raw materials, new processes, new analytical methods and new equipment may be applied to drug production. Among them, the change of drug manufacturing site is an important part of the change in the listing of drugs, which is the most challenging part of the quality risk management of listed drugs.CONCLUSION As the main body of drug manufacturing site change researches, marketing authorization holders should carry out drug production change research, complying with the requirement of series change technical guidelines, to realize the management through the whole life cycle of drug listing.
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2023, Vol. 58 
