Change in batch size for finished product Contribution from Cornelis written on 1/18/2012 at 11:51
According to the EMA variation guideline variation B.II.b.4 (change in the batch size of the finished product), up- or downscaling to 10-fold compared to the currently approved batch size needs to be validated. Is there a generally accepted range (10%, 2-fold, ...?) within a validation is generally accepted to be superfluous? Answers to this contribution:
Answering this Contribution:
|
