It doesn’t matter if it’s generic or innovative molecules, the stability studies are still needed.
The programmes are agreed after the quality specifications for the API are confirmed, though in most cases accelerated programmes and five year long-term programmes are carried out. Our QA specialists will outline the first draft for the stability programme and, once you give your approval, it will be finalised by our QP.
When the API batch is ready and analysed, a small amount (dependable on the amount of the batches, analytical methods, etc.) will be packed and sent to stability storage.
At the moment, we do not have stability chambers, but we work together with our fully GMP qualified subcontractors in the European Union, audited and certified by both us and European agencies of medicines. We at TBD will organise the storage, analyse the samples at each time-point, and send you the stability report.