Quality Control of Analytical Method by Mass Spectrometry

Abstract

The quality control of the data and instruments on the analysis of drugs by mass spectrometry should be controlled by analytical section of pharmaceutical company. ICH, FDA, EMEA, and Ministry of Health and Welfare guidelines related the criteria of quality control of analytical method have been published. The purity and stability of the drugs are analyzed according to Validation of Analytical Procedures (ICH, 1994.10). The clinical pharmacokinetics samples are analyzed according to Guidance for Industry; Bioanalytical Methods Validation for Human Studies (FDA, 1998.12). Toxicokinetics samples are analyzed according to Validation of Analytical Procedures for toxicokinetics (Japan Pharmaceutical Manufacturers Association (JPMA), 1997.3). In this report, I write the actual quality control of analytical instrument and procedure by mass spectrometry in the pharmaceutical companies and compare the above described guideline.