Analytical Method Validation under Good Laboratory Practices (GLPs)

Good Laboratory Practices training (GLP) is essential to any laboratory that supports products for sale or use in the United States. A central aspect of GLP is validation of an analytical method. Completely new compounds are being developed each day in pharmaceuticals — their properties are unknown, and synthetic reactions may create structural and optical isomers. The methodologies that warrant US FDA compliance with GLP regulations require being able to separate and identify all major, minor, and trace components. As per GLP requirements, each minor contaminant or degradation product is also important. This webinar discusses analytical method validation, best practices, components of a validation, critical reagents comparison, selectivity experiments, and the importance of communication between development and validation labs. Code: FDB3460