release or one year after expiry date of the relevant batch, whichever is the longest” is difficult to realize due to the fact that in autologous setting raw materials are used very often for a bigger amount of individual patient batches over a longer period of time. We suggest that the time for retention should be in accordance to shelf life of specific raw materials.
release or one year after expiry date of the relevant batch, whichever is the longest” is difficult to realize due to the fact that in autologous setting raw materials are used very often for a bigger amount of individual patient batches over a longer period of time. We suggest that the time for retention should be in accordance to shelf life of specific raw materials.