EU GMP Annex 1: Consumables in Grade A, Read Closely
The 2022 revision moved contamination control from a chapter to a strategy. For consumables, that means supplier qualification, transfer…
Wiping in Grade B: Residue, Rotation and the Limits of Disinfectants
Disinfectant rotation is a strategy, not a cleaning method. In Grade B, the wipe has to remove what the agent leaves behind. A practical…