QbD Method Development and Validation
The team at Tepnel Pharma performs analytical method development and validation in accordance with the ICH Q2 (R1) guidance and cGMP for both small and large molecules.
Our established method development and validation service offers the development and validation of regulatory compliant procedures ranging from conventional HPLC through to complex monoclonal and polyclonal bioassays that can be routinely used to support either stability testing or lot release testing in the discovery, development and manufacture of pharmaceuticals. You can read more on our Method Development and Validation services here.
We have now invested in Fusion QbD software which in conjunction with Waters® Empower™ and H-Class UPLC Systems provides an integrated solution for robust method development and optimisation, reducing turnaround times from start to finish by ca 30-50% depending on the analytical complexity required.
This approach can be used to design and develop an analytical test method approach using QbD strategy which results in a high quality robust and consistent method ready for validation very quickly when compared to a more traditional approach.