In mid-March, EMA published a revision to its 2005 guideline on stability testing for changes made to a marketing authorization. The revision provides specific indications for a variety of Type II variations previously unaddressed. It clarifies that three months of stability data is required for products known to be stable. For products known to be unstable or if there are changes to the quality characteristics of the active substance, the requirements increase to six months of data. The guideline also requires six months of stability data following changes made to: • excipients that may impact quality • dosage forms • batch size, or • fill volume.
[/membership][membership level=”0,4″][The content continues for paid members only.]
Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]
