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.”
Posted by Tim Sandle
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