ICH Guidelines Show Their Age (and Difficulty)

Throughout this year, our contributing editor Emil Ciurczak has undertaken a series of articles on the need to update ICH guidances--as, he points out, most of them were developed before the PAT/QbD era in pharma. Emil looks at the guidances through a PAT/QbD lens and offers up ways that they'll need revising (when ICH has time to get around to it).

Thus far he has tackled Q2 (R1), Q7A, and Q6A.

His latest analysis is of ICH Q8. We know what you're thinking--Q8 is one of the seminal documents of QbD. True, says Ciurczak: It's not so much that it needs revising, but that it needs ongoing interpretation. Few in the industry read Q8 in full, he notes, and it seems that few interpret it in quite the same way.

If Ciurczak is game, to be continued . . .

--Paul Thomas

FAQ's from the ICH Quality Implementation Working Group

ICH regularly receives industry's questions regarding the implementation of Quality by Design. (Have a question? Submit it to ICH here.) Granted, not all the questions are worthy of response, but those that are are compiled in one Q&A document and made public, as part of the ongoing (and neverending) effort to educate the industry on QbD's finer points.

Some intriguing questions contained within, though perhaps few surprises if you've been following QbD for a while:
--Is there a regulatory expectation to develop a Design Space? (No.)
--Are GMP's different under QbD? (No.)
--Do traditional sampling approaches apply to real-time release testing? (No.)
--What happens when you wander outside of the DS? (It's a deviation under GMP.)

The Q&A's should tide you over until the Trivial Pursuit Quality by Design Edition hits store shelves.

--Paul Thomas

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