Sunday, October 2

Immediate GMP Compliance for Dietary Supplements – What is the cost of Compliance?

The FDA calculated the cost 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, cover all estimated costs, protinex ingredients – pop over to this web-site – concerning compliance, that an organization will incur depending on business size. The FDA estimated that altogether nutritional supplement manufacturers will spend 56,000 hours as a one-time burden in creation of written procedures. Furthermore, 930,000 hours was estimated as the sum total for all businesses to conduct proper record keeping. The FDA then used this data to compute the economic impact for different sized companies.

protetox adCost per Establishment by Size

Little Establishments (Less than twenty employees with annual revenue below $1M)

Little Establishments

Set up Costs = $26,000

Yearly Costs = $46,000

Medium Establishments (20 – 500 workers with annual revenue of $5M – $10M)

protetox adMedium Establishments

Set up Costs = $20,000

Yearly Costs = $184,000

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