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 ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...