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U.S. Department of Health and Human Services

About FDA

Expansion of the Scope of Accredited CBER Test Methods

Description: This project continues the process of obtaining third party accreditation to ISO/IEC 17025 of test methodologies. External accreditation of CBER’s test methods provides additional transparency and further assurance that CBER tested biological products are safe, pure, and potent. Information is current as of September 30, 2012.

Accomplishment: The project’s goal was to have an additional six test methods readied for potential accreditation. CBER in fact readied ten additional test methods for accreditation, and those methods were audited by the American Association of Laboratory Accreditation in August 2012. CBER responded to the audit findings in November 2012. In January 2013, CBER was notified that all ten additional test methods had been accredited to the ISO/IEC 17025 standard.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Complete method development

1/27/2012

Completed 1/26/2012

B. Approve test method documents

3/2/2012

Completed 3/5/2012

C. Complete validation and implement method in Lot Release testing

4/20/2012

Completed 4/20/2012

D. Third party audit

8/31/2012

Completed 8/31/2012

E. Respond to audit findings

11/30/2012

Completed 11/9/2012

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.