Glossary
Equipment Use Log
A per equipment record kept in chronological order showing which product and batch each major item was used for, and when it was cleaned and maintained.
Details
21 CFR 211.182 requires that cleaning, maintenance (except routine maintenance such as lubrication and adjustment), and use of major equipment be recorded in an individual equipment log with the date, time, product, and batch number, that the person performing and the person double-checking each date and sign (or initial) it, and that entries be in chronological order (for equipment dedicated to one product, the batch record may serve instead where batches follow in numerical order). EU GMP Chapter 4 §4.31 requires logbooks for major or critical analytical testing instruments, production equipment, and areas where product has been processed, recording use, calibration, maintenance, cleaning, and repair in chronological order with dates and the identity of the person. If the batch record follows what happened to that batch, the equipment log follows what happened to that equipment, so a cross-contamination investigation or the worst case determination for cleaning validation starts here. Canadian inspections repeatedly cite inadequate usage logs for major manufacturing and testing equipment as a standard finding, along with missing or retrospective entries, gaps between cleaning and next use, and cases where no log existed so the history of use could not be reconstructed.
