Naysayers may believe the Food and Drug Administration's latest plans to revamp current good manufacturing practices (cGMPs) are way too ambitious, but to the believers, it may just be a dream come true that promises to catapult life sciences into the future.
In yet another awkwardly scripted press conference, FDA officials unveiled, one by one, the promising details of a finalized guidance on CFR 21 Part 11, four aggressive draft regulations on aseptic processing, and the formation of a battalion of experts who will police high-risk drug makers.
Of course, depending on the individual, these actions are subject to interpretation. Some will say it's just more of the same policy reflecting reality. Others will see this agenda as a call to action, and an opportunity to contribute to the initiative, Pharmaceutical Current Good Manufacturing Practices for the 21st Century.
And that call is a welcome one, according to Joe Famulare, director of the Division of Manufacturing and Product at the Center for Drug Evaluation and Research (CDER).
Famulare pointed out that Part 11, an often controversial regulation on electronic records and signatures, had the benefit of being finalized through 61 responses and more than 389 comments from the industry.
The response could have been better, and needs to be for an aseptic processing guidance draft that will look at numerous areas of the manufacturing process—including cleanrooms, isolation technology and the critical role of personnel.
It doesn't matter whether you are a naysayer or a believer. What matters is the action you take to cultivate a guidance that will ultimately shape the role of cleanrooms and contamination control technology in the blossoming world of life sciences.
What right will you have to complain if you pass up that chance?
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Mark A. DeSorbo
Associate Editor
CLEAN EXCHANGE
What's behind the curtain
Addressed to Robert Donovan:
I read with interest your article, “New thinking on cleanroom air-flow modeling” (CleanRooms, August 2003, p. 11), and was quite surprised to see the effects of the curtain in the air flow patterns. What happens if the curtain is removed completely? Does the recirculation zone become larger and more pronounced?
David O'Connor
Senior Project Manager,
Bandwidth Foundry Pty Ltd
Australian Technology Park
David,
The flow streamlines resulting from removal of the curtain altogether are more like those of the higher raised curtain case (see Figure 2) of the two curtain positions illustrated in my August column.
This statement holds for both the raised floor return and the sidewall return configurations. For the same dimensions and flow rates but no curtain, the recirculation zone adjacent to the solid bench in the sidewall return configuration is somewhat larger than that shown in Figure 2.
The raised floor configuration shows no recirculation at the same streamline resolution used in the published column. Reference 3 of my column [Yamamoto, 1990] includes a plot of the no curtain case, using the same scale, dimensions and flow rates as the published figures.
I appreciate your interest and response and was delighted to learn of your “surprise,” since a prime reason for writing the column was my suspicion that some readers would react that way.
Bob Donovan
CleanRooms columnist and a process engineer assigned to the Sandia National Laboratories