FDA raises standards for import testing labs

By Nick Taylor

- Last updated on GMT

Related tags Laboratory Fda

The safety of drugs imported into the US remains high on the FDA’s agenda, with the agency publishing new draft guidance that raises standards for labs inspecting products made overseas.

In the guidance the US Food and Drug Administration (FDA) outlines the steps importers must take to qualify to submit abbreviated laboratory packages, which aim to simplify the regulatory process for detained products and those with Import Alerts while maintaining high standards.

The abbreviated laboratory packages can be submitted by private facilities that have gained accreditation, which is granted to sites that comply with the procedures and administrative procedures described in the FDA guidance.

It is recommended by the FDA that laboratories seeking accreditation have the specific tests they are using to generate data for the agency assessed by an independent, science-based organisation.

This should be supplemented by a general assessment of the laboratory’s operations, including the sampling techniques and analytical capabilities of the equipment and personnel.

No particular accreditation body is recommended by the FDA, with laboratories being encouraged to choose one based upon the guidance offered in the document.

In addition to the assessment by an independent accreditation organisation the FDA may periodically visit laboratories, witnessing sample collections and examining worksheets on which a Summary of Analysis is based.

Laboratories that gain accreditation and comply with these oversight measures will generally only have to submit a Summary of Analysis, an affirmation and import documents associated with the entry for FDA review.

Achieving this standard is voluntary but non-accredited facilities will have to submit full laboratory packages, which contain complete data sets, including all raw figures, and information for review by the FDA’s analysts and compliance officers.

The full guidance can be found here​.

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