LC‐MS Instrument Calibration

As analytical and bioanalytical methods must be validated before using them for routine sample analysis and after changing method parameters (see Chapter 8), instruments such as liquid chromatography coupled with mass spectrometry (LCMS) or tandem mass spectrometry (LC-MS/MS), which are utilized to perform the analysis, should be calibrated and qualified. In addition, an instrument’s performance should be tested for suitability prior to use on practically a day-to-day basis. For Good Laboratory Practice (GLP) studies, any equipment (instrument and any computer system used with it) must be tested according to the documented specifications. GLP regulations, which were issued by the U.S. Food and Drug Administration (FDA) in 1976, apply specifically to nonclinical studies used for Investigational New Drug (IND) registration. Shortly after the FDA introduced GLP regulations, the Organization for Economic Cooperation and Development (OECD) published a compilation of Good Laboratory Practices. OECD member countries have since incorporated GLP into their own legislation. In Europe, the Commission of the European Economic Community (EEC) has made efforts to harmonize the European laws. In general, instrument calibration is part of the regulatory compliance for worldwide drug submission. FDA GLP Chapter 21 of the Code of Federal Regulations Part 58 (CFR 21 Part 58) [1] deals with the