Defining by Example

November 2, 2005
Laura Bush

Laura Bush is a former managing editor of Pharmaceutical Technology and Editor-in-Chief of BioPharm International.

Pharmaceutical Technology, Pharmaceutical Technology-11-02-2005, Volume 29, Issue 11

Oddly for a technical meeting, the Oct. 5–7 AAPS Workshop on Pharmaceutical Quality Assessment focused on words, with an entire session devoted to definitions and countless discussions of meaning and nuance.

Oddly for a technical meeting, the Oct. 5–7 AAPS Workshop on Pharmaceutical Quality Assessment focused on words, with an entire session devoted to definitions and countless discussions of meaning and nuance.

Laura Bush

It was heaven for an editor.

AAPS and FDA convened the joint meeting to examine the agency's plans for overhauling the ways it reviews CMC submissions and regulates manufacturing quality. New key words underlie new key concepts in this approach: design space, quality by design, continuous improvement, and quality systems. The discussions made it clear, though, that most attendees from industry and even from FDA itself were unsure what, exactly, many of these terms mean.

That's okay. As any English teacher knows, the best way to give students command of new vocabulary is to have them use the new words and see them in action. Toward that end, attendees met repeatedly in smaller breakout sessions to explore these terms and determine how they would be applied. They used the words in many sentences and, in particular, in many questions.

One breakout session asked how a new-style CMC submission would be distinguished from the traditional type. "We'll know it when we see it," the group's rapporteur reported. Exactly.

"Example is always more efficacious than precept," as Samuel Johnson (the dictionary-maker who defined lexicographer as "a harmless drudge") put it in Rasselas.

For industry and FDA to master the meaning of this new vocabulary, we must see the concepts in practice. Design space, for example, will only truly start to take on meaning after a company applies the concept in a new drug application, and the company and the regulators debate its boundaries and determine the rules around changing it.

So the new terms, and their definitions, are useful. They provide a framework for thinking about a new approach. But it will take implementation to know what they really mean, and how the new system will work.

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