A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel. Q. During the periodic review of our ...

After having done a procedure multiple times, it may become completely routine, but having documentation can help when you have staff turnover or are away from that task for a length of time.

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the ...