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 ICH: What's Your Take?

Some discussion has started up around ICH's Q&A document on our LinkedIn group. If you're not a registered LinkedIn user, my apologies. I will summarize these responses some time soon. In the meantime, I would love to hear other thoughts about the value of ICH's document, and any answers that you take issue with.

--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

Can PCMO and PQLI Work in Harmony for Paradigm Change?

PDA has stepped up its efforts to get its training and technical reports more in tune with ICH and a more risk- and science-based industry. These efforts have been underway, says PDA's Rich Levy, but the Paradigm Change in Manufacturing Operations initiative puts them into focus.

PDA has drafted a dossier around four key themes: Life Cycle Approach, Quality Systems, Process Management, and Quality Risk Management, and will use this dossier as the umbrella under which ongoing efforts will be undertaken.

In this article from my recent discussion with Levy, he goes out of his way to emphasize that PCMO is intended to complement, not counter, PQLI efforts already underway at ISPE.

--Paul Thomas

PDA Releases Dossier for Paradigm Change Initiative

PDA has instituted a new "Paradigm Change in Manufacturing Operations" (PCMO) initiative, based largely on encouraging ICH guidance within its organization and the industry. Here is the PCMO dossier, and we'll be following up with PDA in the near future.

--Paul Thomas