Related FDA483/Warning Letter The written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically: Sub section (b)There is no written standard operating procedure in place to (A) control, secure, and allow authorized personnel to access the stability chambers. It appears that...
Posts Tagged with Inventory
Chain of Custody / 483
Chain of Custody is the documentation of your samples lifecycle history. Most people don’t realize that Chain of Custody starts very early in the manufacturing process and continue through the testing phase. All stages of a sample’s life cycle have some sort of chain of custody or an inventory...