Quality by Design and the new FDA Process Validation Guidance. How do they fit together?March 12th, 2012 by Peter Calcott
At a recent IBC conference on Product and Process Validation, I moderated a panel discussion on this topic with four panelists in addition to myself. They included two from Pfizer, and one each from Genentech/Roche and Shire Pharmaceuticals. What were the conclusions:
- All companies were finding the efforts of QbD painful and laborious and were only just beginning to touch on the new PV guidance. This was true for the larger companies and especially so for the smaller ones.
- Some were seeing a back pedalling by the regulators on what benefits the companies might reap for this added work.
- All recognised that the very small company might find it exceedingly painful if not impossible.
Stay tuned, I will be writing more on the topic.