Posted by Rick Soltero

What does your company spend on compliance with Good Manufacturing Practices?  Is it more than the FDA estimates?

FDA's Cost of Compliance Calculation

The FDA calculated how much record keeping for GMP manufacturing would cost after their 2003 DSHEA act went into effect.  Here is what they projected:

	Number of Employees	Annual Revenue	Setup Costs*	Annual Costs*
Small Establishments	<20	Under $1 million	$26,000	$46,000
Medium Establishments	20 - 500	$5 to $10 million	$20,000	$184,000

Our goals is to bring down these costs through more efficient electronic manufacturing.