Friday, 15 March 2013

QbD and the New Process Validation Guidance

PharmaPro are hosting an interesting article by Bikash Chatterjee and Wai Wong, Pharmatech Associates on the subject of ‘QbD and the New Process Validation Guidance’.

The introduction to the article reads:

“Very simply, the aim of pharmaceutical development is to design a quality product and manufacturing process to consistently deliver the intended performance of a final therapeutic product.

To support a final quality assurance approach to manufacturing, it is the information and knowledge gained from pharmaceutical development studies and process characterization studies that lead to an effective quality control strategy, based on scientific understanding.

To that point, in January 2011 the FDA issued its new guidance on Process Validation (PV). The new PV guidance uses the basic principles of scientific understanding put forth in ICHQ8—the foundation of Quality by Design (QbD)—to establish process understanding and link it to product reproducibility. It effectively abandons the old concepts of demonstrating process validation and replaces it with a new, structured approach. It formalizes these principles by describing the level of product and process understanding necessary to satisfy the requirements of Stage 1 of the new PV guidance. To achieve this level of process understanding a framework that integrates product performance as part of process characterization is required. So simply put, the new PV guidance will make it much easier to justify moving toward QbD.

The challenge that many industry personnel face is bridging the gap between the former validation approach of “three batches and we’re done” to understanding how the new PV stages work together to establish process predictability.”

The article can be viewed free on line via PharmPro

Posted by Tim Sandle