By David Jensen, Staff Writer, MasterControl
Equipment management is an essential part of product manufacturing. For companies developing regulated products, everything that happens to equipment (cleaning, calibration, maintenance, repairs, and usage) must be appropriately documented to maintain compliance with current good manufacturing practices (cGMP). Equipment activities are commonly entered in a large, bound manufacturing logbook.
All manufacturers are required to maintain logbooks and routinely review them for accuracy, clarity, and completeness. 21 CFR Part 211.82 cites that “A written record of major equipment cleaning, maintenance, and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed.” The written records must also follow the guidelines for data integrity.1