The initial draft of the EU Guidance for Process Validation was released for comment and the comment period closed in October. So what has the thoughts on the new guidance since it was released? Read the linked article in Master Control on line journal for some insights.
The Calcott Consulting Blog:
Articles on Quality by Design:
In February I published an article on the topic of Quality by Design as it applies to the Vaccines World. This was based on a presentation at an IBC conference on vaccine development. As you might imagine, QbD has been slow in development of biologics but even slower in Vaccines. Check out the article on the IBC website
There has been a lot of discussion at conferences and on LinkedIn as to whether QbD is just for big Pharma and Biotech and whether smaller companies are being discriminated against. This triggered me to write an article for Metric Streams, GXP Lifeline. Enjoy
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.
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