Wednesday, August 21, 2013

It's True: FDA Inspectors Judge Books by Covers

It's 483 month over at and strategy #5 for avoiding dreaded inspectional observations is:
Don't Neglect Your Physical Plant
While it seems like a no-brainer to maintain the physical plant (i.e. perform work orders and change orders to keep the facility performing), judging the physical plant by appearance is a bit superficial.

FDAzilla writes:
One former compliance official used a simple test to get a sense of how seriously companies took having a clean operation: he’d walk into the men’s room and check it out. “If it isn’t clean in there, how can you be making a good product?” the official says.
Does a dirty men's room mean that an entire facility - whose validated environmental monitoring, bioburden levels do not exceed alert or action limits - is also not clean?  It's one thing to conclude that the factory is out of control by looking at the data within validated systems; it's quite another to be judging from the bathrooms.

blank book Sadly our experience comports with FDAzilla's reporting: that FDA inspectors judge books by their covers.

As the saying goes, "neatness counts," and neatness in the GMP world can help sweep a lot of real GMP problems under the rug.

I know of a plant that would go and paint the handrails in the stairwells every time a contingent of regulatory inspectors arrive.  Handrails that get scratched by the button on the gowns operators wear are scratched up all year long, but as soon as an FDA inspector arrives, you have people out there painting it.

This isn't new to me.  Cornell University would have all kinds of construction: orange nets, backhoes, jackhammer noises all year long, but as soon as it was commencement week and the alumni and parents showed up, all the equipment would get packed up and it'd look just like their college brochure.

Biologics manufacturer knows that neatness counts; and they attend to superficial details because neatness can help them avoid 483 inspectional observations.

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