Thursday, January 15, 2009

Third party certification: FDA final guidance

Valerie of the Fresh Produce Industry Discussion Group linked first to this press release from the FDA today. Looks like all third party inspectors, including state and federal government, are cut in to the deal. I've lopped off parts of the news release that don't apply to food....Look for more reaction/analysis tomorrow.

The U.S. Food and Drug Administration today issued three guidances designed to help ensure the safety of FDA-regulated products in the supply chain. The documents issued today include the following:

  • Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds;
  • Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories; and
  • Draft Guidance for Industry on Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages.

"The guidance documents reflect the FDA's continued vigorous efforts to minimize the chances of unsafe products reaching American consumers," said Jeffrey Shuren, M.D., J.D., associate commissioner for policy and planning.

The Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds discusses the attributes of a third-party certification program that would merit the FDA's confidence in the quality of the program's audit. The guidance, finalizing a draft published on July 10, 2008, is intended as one of the steps in the FDA's future recognition of voluntary third-party certification programs for foods and animal feeds. The document makes clear that it applies to any third-party certification body, including a private entity or a non-FDA federal, state, local or foreign regulatory body. Third-party certification programs can augment the ability of the FDA and the importing community to verify product safety.

Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds: http://www.fda.gov/oc/guidance/thirdpartycert.html

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