Question: Phase II registered clinical research, the investigational drug was collected at the research center and transferred to a GMP factory for analysis method development and quality research. Is this operation acceptable
Answer: Article 49 of Chapter 13 of the "Good Manufacturing Practice for Drugs - Appendix to Clinical Trial Drugs" (draft for solicitation of opinions) released in January 2022, "Withdrawal and Destruction", should be avoided as much as possible to prevent clinical trial drugs from being used again after being withdrawn. If necessary, the applicant shall evaluate the quality of the recovered clinical trial drugs, dispose of them in accordance with the corresponding operating procedures, and use them after evaluation. If clinical research drugs are recycled from the research center and assigned for other purposes, this needs to be specified in advance in the "Drug Management Plan" or equivalent documents, and supported by the company's corresponding SOP. Due to the consideration of temperature control and the risk of re contamination during drug transportation, it is generally recommended to dispose of the drug after recovery, rather than reanalysis. Suggest inviting relevant departments to jointly evaluate and decide.

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