More steps toward enlightened industry
10/01/2002
You can argue that "change" and "progress" are inexorably linked—change for the better yields progress.
On this month's cover, Associate Editor Mark DeSorbo continues to track the progress the U.S. Food and Drug Administration (FDA) is making following news that it plans to revamp a manufacturing practices program that it last enhanced 25 years ago. We plan to follow the initiative from public forum to implementation and gather industry input at our own "open forum" at CleanRooms East in Boston in March 2003.
The news of this revamp comes at a critical time.
It's certainly not news to our life sciences readers that production has fundamentally advanced, while bio-based technologies and practices have sped into hyper-space. Advances in tissue engineering and genomics, for example, have simply never fit into the older FDA framework.
This is the time to unravel that mysterious relationship that's evolved over the years between the regulator and the regulated. Miscommunication and misinterpretation have unavoidably led to staggering fines and even more costly delays in crucial developments.
Last month I used this space to applaud Semiconductor Equipment and Materials International's (SEMI) Global Care program and the 42 CEOs who've signed on to build awareness of environmental health and safety throughout the entire semi production process. This month I applaud the FDA.
The critics may sit back and say initiatives like these are nothing but "lip-service" by organizations forced to at least appear proactive. I say it's the first step to a new and more enlightened industrial society.
APC is all the rage
The idea behind advanced process control (APC) has had semi manufacturers a tingle for years. Imagine: Automating complex processes in high volume and making real-time adjustments to any part of the manufacturing process to minimize costs while fantastically decreasing contamination and ultimately increase yield.
September's Special Report, "Tying the great machine together," touched on many new APC technologies and "ideals" that we would have only dreamed of implementing five or six years ago.
At the recently concluded AEC/APC symposium in Snowbird, UT, Intel's VP and GM of fab/sort manufacturing, Brian Harrison, was heard saying that, by utilizing APC, the chip maker's rework has been reduced by 50 percent, headcount has been reduced and it certainly plans to increase its APC applications as it moves to 130 nm and beyond.
Next month, we're going to take a deeper look into the recent news that AMD and UMC are collaborating in forwarding APC.
The fruits of this joint labor will, the companies say, be implemented at the companies' joint-venture 300 mm fab in Singapore that is expected to begin production in 2005.
Just how will APC ultimately impact contamination control? The story is only beginning to unfold.
Michael Levans
Chief Editor
A giant leap for life sciences
It came as a surprise, but the news wasn't shocking when the U.S. Food and Drug Administration (FDA) announced its initiative, Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach.
Consider the climate of compliance in the wake of the largest fines imposed on the pharmaceutical industry in history, not to mention a complete disregard for contamination control by the nation's largest tissue bank.
The FDA has indeed made a bold step toward change, embarking on a journey that will ultimately overhaul warmed over current good manufacturing practices (cGMPs) and align them with cutting-edge life sciences technologies.
The initiative has sparked a range of emotions. Some say the effort is a waste of time, while others say it is too soon to tell. Perhaps the most notable sentiment is that it is about time the FDA did something.
It has often been an us-and-them scenario between the federal government and many factions of the life sciences industries, but the "them" in that scenario has turned to the very industries it polices for help.
And while it may never be a perfectly harmonious relationship, the FDA's proverbial eyes and ears are wide open, for this is the time, the time to contribute to the making of science-based protocols that will ultimately galvanize a growing global industry that already beams with great miracles.
Turn a deaf ear to those who have forgotten the true meaning of life sciences and herald the innovations that continue to make what was thought to be impossible happen.
Mark A. DeSorbo
Associate Editor