H1N1 Puts Onus on Industry to Embrace QbD and FDA's Risk-based Dream

If ever there were a time for the industry to embrace QbD, it is now, as the threat of an expanding H1N1 pandemic looms and manufacturers scramble to develop and manufacture significant volumes of vaccines to counter the spread of the virus. In this his latest article (also published in the July/August issue of Pharmaceutical Manufacturing), Pharmatech's Bikash Chatterjee puts the threat in perspective (looking back towards the bird flu and even Spanish flu of 1918), and makes an impassioned case for the adoption of Q8 and Q9 principles as a means of accelerating development and helping to reduce or even extinguish the danger that H1N1 presents.

He concludes:

For an industry that has had its fair share of bad press in the last few years over public safety concerns, this is our chance to step up to the plate and show we can deliver when we need to. If we fail, the FDA can look to another long, slow transition as it struggles to enforce its new policies on risk-based process development and quality assurance.

--Paul Thomas