How to handle Out-of-Specification (OOS) batches of ATMPs?

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.

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