EMA Offers Q&A on Using OOS Batches of Authorized ATMPs

The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT), together with the GMDP Inspectors Working Group and the Blood Products Working Party, have released a questions and answers (Q&A) document on how companies should go about using OOS batches of authorized cell or tissue-based advanced therapy medicinal products (ATMPs).

See: https://www.ema.europa.eu/en/documents/other/questions-answers-use-out-specification-batches-authorised-cell/tissue-based-advanced-therapy-medicinal-products_en.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology