If you do any work that will be reported to the US Food and Drug Administration (FDA), Environmental Protection Agency (EPA), or Occupational Safety and Health Administration (OSHA), your work must be done under GLP.All methods must be validated, the proof that they do what is claimed. Common criteria are accuracy, precision, linearity, range, and several more.
Any laboratory that supports products for sale or use in the United
States must follow Good Laboratory Practices (GLP), a comprehensive
system that guarantees validity of results. If you work in
pharmaceuticals, chemicals and petrochemicals, and environmental
analyses then you are mandated to be following GLP. One of the major
tasks in GLP is validation of an analytical method.
The new pharmaceuticals are very often completely new compounds,
structures never studied before by chemists. Their properties - such as
solubilities and acid-base nature, are unknown. Synthetic reactions may
make many similar types of molecules, including structural and optical
isomers. The methodologies that mean US Food and Drug Administration
compliance with GLP require a separation to be able to separate and
identify all major, minor, and trace components. It is no longer just
determining a purity of the main component. Each minor contaminant or
degradation product is also important in GLP.
This analytical method validation webinar will provide practical tips on how to validate an analytical method under the GLP requirements. It is recommended for laboratories that are under, or want to be under, Good Laboratory Practices (GLP).