Calibration and Qualification of Laboratory Instruments in Accordance with GMP Requirements

Calibration is relevant to everyone. Even the most precise measurement instrument is of little or no use if you cannot guarantee that the reading is accurate, or you are unaware of the measurement uncertainty. The US GMP rule for pharmaceutical manufacturing, 21 CFR Part 211, article 68(a) provides details on calibration of measuring equipment. Similar statements can be found in other regulatory or guidance documents, such as ISO9001, which emphazises the traceability to international or national measurement standards. The challenge is to determine how to put these regulations into practice—to be confident that you comply with the requirements without an excessive amount of effort—but without compromising product quality.