This is the world of "scratch pad GMP." An analyst runs an HPLC test and gets an Out of Specification (OOS) result. The official logbook shows they stopped testing at 3:00 PM. But the Devil’s SOP says: "Test until you pass. Use the 'Trial' folder on the desktop. Only print the passing run."
The first rule in the Devils SOP is the . Instead of initiating a full investigation (which costs time and money), the procedure dictates repeating the test until passing results appear.
Ensuring every ingredient and action can be traced back to its source or actor.
