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<key-projects><projects><title>Rapid Screening of Pharmaceuticals</title><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.</description><dictionary></dictionary><outcome></outcome><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.</accomplishment><table><title></title><row><type></type><milestone-description>1. Complete collaborative studies of initial Critical Path proposal with ORA</milestone-description><milestone-date>10/31/2009</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>10/31/2009</milestone-completion-date></row><row><type></type><milestone-description>2. Finalize development of 10 methods</milestone-description><milestone-date>3/31/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>12/31/2009</milestone-completion-date></row><row><type></type><milestone-description>3. Transfer instrumentation and methods to field laboratories</milestone-description><milestone-date>9/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>9/30/2010</milestone-completion-date></row><row><type></type><milestone-description>4. Release study report and develop publications</milestone-description><milestone-date>9/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>9/30/2010</milestone-completion-date></row><footnotes><note></note></footnotes></table></projects><related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htm</url><text>FDA-TRACK CDER Dashboard</text></link><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm204013.htm</url><text>FDA-TRACK ORA Regional Offices Dashboard</text></link><link><url>http://accessdata-test.fda.gov/FDATrack/track-proj?program=cder&amp;id=CDER-OTR-Rapid-Screening-of-Pharmaceuticals-Resources</url><text>Additional Articles Related to Rapid Screening of Pharmaceuticals</text></link></related-links></key-projects>

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