Wednesday, January 14, 2009

FDA Draft Guidance On Good Importer Practices

A group of federal agencies issued a draft guidance for industry on Good Importer Practices, with the intent to help importers ensure their products are safe and comply with U.S. requirements, FDA Guidance for Industry – Good Importer Practices.

The guidance is designed to anticipate potential sources of product hazards and offer preventive controls that firms can implement to mitigate such hazards and help ensure imported products are safe and compliant with regulations. The draft is organized under 4 guiding principles . . .

  1. Establishing a product safety management program
  2. Knowing the product and applicable U.S. requirements
  3. Verifying product and company compliance with U.S. requirements throughout the supply chain and product life cycle
  4. Taking corrective and preventive action when the imported product is not in compliance with U.S. requirements

The draft guidance also recommends that:

  • importers consider instituting practices to identify and minimize risks associated with imported products
  • in general, importers should know the producer of the foreign products they purchase and any other manufacturers with which they do business, such as consolidators, trading companies, and distributors
  • importers understand the products that they import and the vulnerabilities associated with these products
  • importers understand the hazards that may arise during the product life cycle, including all stages of production, and ensure proper control and monitoring of these hazards

The agencies are issuing this draft guidance to implement recommendations outlined in the “Action Plan for Import Safety: A Roadmap for Continual Improvement,” issued by the Interagency Working Group on Import Safety, and to help foster a consistent approach by federal agencies and importers in ensuring the safety of products brought into the United States.

Related Posts:
FDA Struggles To Keep Products From Foreign Sources Safe
FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants

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