The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories. An important operation in the registration ...

Bioassay variability can pose significant challenges due to laboratory conditions, instrumentation, analytical software, cell ...

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 ...

As drug development becomes more complex, so do the demands for accurate, reproducible bioanalytical data to prove their safety and efficacy. Method validation ensures the reliability of ...

Journal of the Washington Academy of Sciences, Vol. 95, No. 3, SPECIAL ISSUE: SCIENCE AND PUBLIC POLICY (Fall 2009), pp. 113-125 (13 pages) Over the last decade food safety and food control have ...

This Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method ...

This article considers the distinction among the terms qualification, validation, and verification in the context of pharmacopeial usage.A recommendation for a standardized usage of the terms ...

However, effectively assessing their validation technique proved to be a challenge. "We are not evaluating a method, instead we are evaluating an evaluation. So, we had to step back, think carefully, ...