24th of September 2019
How to handle Out-of-Specification (OOS) batches of ATMPs?
24th of September 2019
How shall an ATMP that is just out of specification be handled? Can these potentially life-saving drugs still be administered on a risk-based basis? The EMA provides a first orientation guide to answer these and additional question and has recently published a Questions and answers paper entitled "Questions and answers on the use of out-of-specification batches of authorised cell/tissue-based advanced therapy medicinal products”. Here, different aspects of not only responsibilities and documentation but also notification of the EMA and patient information are discussed.
Find out also about our services on the subject of GMP for ATMPs
Dr. Ellen Sons-Brinkmann
Tel: +49 69 153 293 709
Mail.: ellen.sons-brinkmann@valicare.com