The onset of COVID-19 pandemic has seen a surge of products claiming viricidal / antiviral properties for reducing the prevailing infection burden. Any antivirals intended to protect public health must be registered with the national regulatory agency. As a part of the process, efficacy data under Good Laboratory Practices must be generated.
The manufacturing companies must submit chemical characterization, safety, and efficacy data generated in compliance with GLP regulations for registration purpose. Testing the products under the principles of GLP not only promotes to study their properties and/ or their safety regarding human health and / or the environment, but it also aids the development of quality test data.
Regulatory agencies have been supportive to (A) conduct more in-vitro studies to discourage the use of animals as alternatives (B) using high throughput screening techniques to generate data for safety testing purpose, thus underpinning the requirement of GLP to ensure quality and integrity to test data for product application submission.
These studies can provide vital information that can affect the success of the product. Complete virology study reports can be extensive and should include the primary data and derived data, the procedures used to get the data and information necessary to test the data.
This webinar will provide insight into testing of products for virucidal properties with appropriate application of the principles of GLP for assuring quality during the evaluation studies.