In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

Intimate Connectivity Must Be Maintained Throughout the Product’s Lifecycle The link between product specifications and analytical methods throughout a product’s lifecycle makes intuitive sense. One ...

The devices around us that generate and store the energy that powers our electronics and propels our vehicles rely on intricate chemistry that often happens in tiny spaces. But those ...

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 ...

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 ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, guided by regulatory frameworks like FDA and ICH. Technological advances, ...