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.

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Developing and managing a relationship with a Contract Manufactring Organisation (CMO) is difficult and fraught with challenges.  Read an article I wrote on the topic recently that appeared in the European Biopharmaceutical Review.  Pleasant reading.

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The blog is intended to create a forum to share thoughts and pose questions. The topics will be those that catch my eye from FDA Warning Letters, that are stimulated by new regulatory guidances, that are discussed with colleagues and those that come up in discussions with colleagues.

Will they be dry? I hope not.
Will they be topical? I hope so.
Will they be controversial? Maybe.

Stay tuned and come back to check out.

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