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Immediate GMP Compliance for Dietary Supplements – What’s the price of Compliance?

The FDA calculated the cost of Good Manufacturing Practices (GMP) when they first drafted the Dietary Supplement Health and Education Act (DSHEA). Dietary product GMP regulations, located weight loss pill expands in stomach (written by www.dnaindia.com) the Federal Register, cover everything estimated costs, associated with compliance, that a company will incur based on business size. The FDA believed that altogether dietary supplement companies will invest 56,000 hours as a one-time burden of development of written procedures. Furthermore, 930,000 hours was estimated as the sum total for those business enterprises to conduct sufficient record keeping. The FDA then used this data to estimate the economic impact for various sized companies.

Cost per Establishment by Size

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

Small Establishments

Set up Costs = $26,000

Annual Costs = $46,000

Medium Establishments (twenty – 500 employees with annual earnings of $5M – $10M)

Medium Establishments

Set up Costs = $20,000

2 weeks agoAnnual Costs = $184,000

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