Analytical Method Validation under Good Laboratory Practices (GLPs)

Description:

Good Laboratory Practices training (GLP) is essential to any laboratory that supports products for sale or use in the United States. GLP much like GMP ensures a comprehensive system that guarantees validity of results and overall quality. Pharmaceuticals, chemicals, petrochemicals, and environmental analyses companies mandated to be following GLP training. A central aspect of GLP is validation of an analytical method.

Completely new compounds are being developed each day in pharmaceuticals, structures that have never studied before by chemists. Their properties – such as solubility and acid-base nature, are unknown. Synthetic reactions may create similar types of molecules, including 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. No longer is it just determining a purity of the main component, environmental analysis is a pre-requisite. As per GLP requirements, each minor contaminant or degradation product is also important.