Immediate GMP Compliance for Dietary Supplements – What is the cost of Compliance?
The FDA calculated the cost of Good Manufacturing Practices (GMP) if they 1st drafted the Dietary Supplement Health and Education Act (DSHEA). Dietary supplement GMP regulations, exipure fat loss (please click the up coming document) located in the Federal Register, encompass all estimated expenses, relating to compliance, that an organization would incur depending on business size. The FDA estimated that altogether dietary supplement companies will spend 56,000 hours as a one-time burden in development of written methods. Additionally, 930,000 hours was estimated as the sum total for all companies to carry out adequate record keeping. The FDA then used this data to compute the economic impact for different 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 workers with annual earnings of $5M – $10M)
Medium Establishments
Set up Costs = $20,000
Yearly Costs = $184,000