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U.S. Department of Health and Human Services

About FDA

Rapid Screening of Pharmaceuticals

Description: This project develops portable methods that can be deployed by Office of Regulatory Affairs (ORA) field laboratories and inspectors for the screening of pharmaceutical ingredients such as contaminated heparin, ethylene glycol and heavy metals.

Accomplishment: This project developed portable methods that can be deployed by ORA field laboratories and inspectors for the screening of pharmaceutical ingredients such as contaminated heparin, ethylene glycol and heavy metals. OTR has loaded at least two methods onto each handheld/portable instrument. OTR has completed development of training materials including standard operating procedures and DVDs. Publications have been submitted for each instrument describing method development and any novel chemometric tools used to improve sensitivity and selectivity of the methods. OTR also described the rapid screening program to Chinese and Indian government officials in hopes of developing future collaborative efforts. OTR and the China National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) have also established an exchange to learn about each others approach and technique for screening pharmaceutical ingredients and products. Although this marks the end of OTR’s efforts on this project, the filed deployment portion is continuing in the Office of Regulatory Affairs (ORA) and is a Key Project on their Dashboard.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Complete collaborative studies of initial Critical Path proposal with ORA

10/31/2009

Completed 10/31/2009

2. Finalize development of 10 methods

3/31/2010

Completed 12/31/2009

3. Transfer instrumentation and methods to field laboratories

9/30/2010

Completed 9/30/2010

4. Release study report and develop publications

9/30/2010

Completed 9/30/2010

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.