Answer： This depends on the role and positioning of the warehouse in this clinical trial. If the warehouse only completes the storage of the study drug, the distribution of the study drug to the research center, and the recycling of the study drug, then the distribution of the study drug from the warehouse to the research center does not require GMP/CMC QA intervention, as GMP QA has already completed the "release" when the study drug is transferred from the production site to the warehouse. If the warehouse conducts repackaging and re labeling operations during the storage of research drugs, a comprehensive evaluation should be conducted by GMP/CMC QA before the research drugs are distributed to the research center to make a decision on whether they can be released. The reference document is the "Good Manufacturing Practice for Clinical Trial Drugs" that came into effect on July 1, 2022