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New White Paper for Dietary Supplement Manufacturers Provides How-to for New FDA Compliance Paradigm
Date:9/27/2011

o guidance on:

  • Developing the Necessary Quality System
  • Management "Buy In"
  • Microbiological Testing/Practices In The USP Dietary Supplement Compendium and FDA BAM
  • Chemistry and Manufacturing Controls (CMC)

The white paper is available at: http://www.microtestlabs.com/dietarypaper.

"The challenges for small and medium sized manufacturers are these: Testing dietary supplements and determining compliance requires the personnel and facilities to handle large-scale testing programs. The ability to train and retain these employees may be a challenge. And a full cGMP assessment is required for each manufacturer.

"Compliance with the intent of the law will be determined by management's buy-in to a robust quality program with concomitant lab support," Richter said. "Given all this, for many small and medium sized manufacturers, outsourcing the majority of their testing may make most economical sense."

For a full discussion of the issues surrounding the FDA's Good Manufacturing Practices (cGMP) for Dietary Supplements, download the new, free white paper, "Dietary Supplements — A New Paradigm for Manufacturers," from http://www.microtestlabs.com/dietarypaper.

For more information, visit http://www.microtestlabs.com. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest

Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company's expertise and flexible processes e
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SOURCE Microtest
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