For post-approval site change of biologics, how to determine the shelf life for drug product manufactured at the new site?

刊登日期:2019-06-26  |  點閱次數 : 1350 次 

At least 6-month long term stability data is suggested to be provided. If the comparability studies show satisfactory results between pre- and post-change products, the approved shelf life could be relevant for post-change product, however, the long-term stability study should be completed for confirmation.



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