GLP Bioanalysis from the US FDA Perspective

The United States Food and Drug Administration is responsible for ensuring US residents receive safe and effective medicines. Since blood levels of drugs are correlated with pharmacological effect, FDA closely regulates how those blood levels are measured. The FDA has established requirements for bioanalytical analyses such as minimum method validation, SOP, and reporting criteria. The FDA also has standards for computer validation which must be followed to ensure the data are reliable. Data presented to the Agency are scrutinized to ensure they are accurate and a true reflection of the raw data generated in a study. To verify the quality of data, FDA has developed an inspection program. The specific requirements of the FDA related to bioanalysis will be discussed.