Coming … soon?

Laura Bush

I am as averse to change as anybody. Okay, I’m more averse to change than just about anybody I know. I’m not a stick-in-the-mud, just cautious. When a new shoe style comes out, for example, I always think it looks odd. Two years later, I buy it–in time to be in fashion for at least a little while.

Of course, the pace of change in the pharmaceutical world is bit slower than in the fashion industry, and with good reason. Even seemingly innocuous upgrades to shipping pallets are scrutinized (see Packaging Forum, page 32). Distributors are seeking options to wood, which can cause problems with airborne particulates and vermin, hut replacements must meet tough standards of weight, cost, and durability.

So when it comes to bigger changes such as implementing new automated process controls, the industry is particularly careful. As Rios notes in her special report on the topic (page 40), a big part of the current reluctance is that the industry is still sorting out how to manage electronic signatures and overall system access according to the rules of 21 CFR Part II. As Rios says, companies aren’t going to embrace high-tech electronic systems “until the industry is as comfortable with Part II as it is with e-mail.”

Fortunately, some folks in the industry are early adopters of new methods and technologies. Like those at GlaxoSmithKline, who received the first FDA approval under the agency’s process analytical technology (PAT) initiative (see the article in our PAT supplement that accompanies this issue). The company took the challenge head on and can now reap the benefits of increased efficiency and tighter quality controls. And FDA did its part too, working with the company in what we understand was a pretty quick and smooth approval process.

Remember when nobody had e-mail? Just imagine trying to live without it now. One day, we’ll feel that way about a whole host of pharmaceutical technologies that now seem new. It’s just a question of when.

Laura Bush, Managing Editor

COPYRIGHT 2004 Advanstar Communications, Inc.

COPYRIGHT 2004 Gale Group

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