No longer 3 golden batches, so just how many Process Performance Qualification batches should I run?

The debate on the number of batches used to determine if a process is validated or not has come under some scrutiny since the update of the US FDA’s Guide to Process Validation in 2011. As a result of the update, industry has tried to come up with a number of ways to help to … Continue reading No longer 3 golden batches, so just how many Process Performance Qualification batches should I run?