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A few words of advice for our life sciences readers who are engaged in the uphill battle of developing, installing and maintaining current good manufacturing practices (cGMP) and cleaning procedures: The FDA is still able to flex its muscle.
While the number of FDA facility inspections fell by 14 percent last year, don't expect that percentage to increase —quite to the contrary.
Over the past few years, the FDA has been pegged as a stumbling giant, with its lack of inspectors and budgetary constraint well publicized in the mainstream media. As Mark DeSorbo mentions in this month's cover story, “Drug makers beware, FDA on the prowl,” it's now reported that the Bush administration is going to be “far more helpful” to the FDA than was the previous administration.
Read into that reference what you like; however, my suggestion is to clip Mark's story and send it, inter-office, right up the chain of command. Fines ranging from $30 million (American Home Products) to $100 million (Abbott Labs) based on “contamination” and “failure to validate procedures” are sure to fog the reading spectacles of even the stodgiest CEO.
It's stories like this that send a charge through the editorial staff here at CleanRooms. This is news, which, in turn, is based on actual events and facts. This is not an opinion piece assigned out months in advance to walk readers through a procedure. This is ammunition that the conscientious QA/cleanroom manager is going to use to tie training, cGMP and any other clean manufacturing initiative you've been trying to fund, to the bottom line.
And if you need additional help in your research, just run an archive search for the word “validation” at CleanRooms.com. From there you'll be given a list of 167 articles on establishing procedures as well as the consequences your company will face if these procedures are not established and followed. The virtual library exists—use it.
A final note: It's been a while since we covered cleanroom lighting in these pages. With lighting consuming less than 1 percent of an average cleanroom budget, it's no wonder we haven't devoted more ink to the subject. But with energy costs coming to the forefront for cleanroom managers, we thought it best to bring the issue back into the light.
Michael Levans
Chief Editor