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Quality by Design and the new FDA Process Validation Guidance. How do they fit together?

March 12th, 2012 by

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:

  1. 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.
  2. Some were seeing a back pedalling by the regulators on what benefits the companies might reap for this added work.
  3. All recognised that the very small company might find it exceedingly painful if not impossible.

The panel discussion was published in Pharma QbD and I have included a link so you can read more.

Stay tuned, I will be writing more on the topic.

Posted in Clinical Manufacturing, Commercial Manufacturing, GMP, News, Process Validation, Quality by Design| Tags: |6 Comments

Quality by Design and the new FDA Process Validation Guidance part 2

January 5th, 2012 by

The second part of the article I wrote on the above topic has been issued in the December issue of BioProcessing International.

Click here for the article.  Good Reading

Posted in Clinical Manufacturing, Commercial Manufacturing, FDA Guidance, GMP, Process Validation, Quality by Design, Risk Management| Tags: |Leave a comment

Quality by Design and the New FDA validation guidance

November 18th, 2011 by

If you following the link here, you will see an article I recently wrote on the topic.  Good reading.  If you have any questions email me at peterc@calcott-consulting.com

Posted in FDA Guidance, GMP, Process Validation, Quality by Design| Tags: |Leave a comment