The proper use of certified reference materials for analytical instrumentation qualification

摘要

The proper validation of an analytical instrument is a topic that has long concerned me. Laboratories accredited to ISO/IEC 17025 put much effort into validating a method, but the starting point should be that the analytical system is working properly because it has been calibrated using a certified reference material (CRM). In the good manufacturing practice (GMP) world of the pharmaceutical industry, instrument qualification is part of the quality culture. Machines are checked, in some cases on a time basis, in other cases if anything at all has been changed, such as a column or pump part.