Instant GMP Compliance for Dietary Supplements – What’s the price of Compliance?
The FDA calculated the price of Good Manufacturing Practices (GMP) whenever they 1st drafted the Dietary Supplement Health and Education Act (DSHEA). Dietary product GMP regulations, located in the Federal Register, encompass everything estimated costs, powdered weight loss formula – more info, concerning compliance, that an organization will incur based on internet business size. The FDA estimated that altogether dietary supplement makers will spend 56,000 hours as an one time burden of creation of written procedures. Furthermore, 930,000 hours was estimated as the sum total for those business enterprises to carry out adequate record keeping. The FDA then used the data to compute the economic impact for a variety of sized companies.
Cost per Establishment by Size
Little Establishments (Less than twenty employees with annual revenue below $1M)
Small Establishments
Set up Costs = $26,000
Yearly Costs = $46,000
Moderate Establishments (twenty – 500 employees with annual revenue of $5M – $10M)
Medium Establishments
Set up Costs = $20,000
Annual Costs = $184,000