USP Monograph Development Process and Compendial Updates
USP Monograph Development Process and Compendial Updates
USP Monograph Development Process and Compendial Updates
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Heavy Metals• <strong>USP</strong> is actively seeking industry input– <strong>USP</strong> Annual Scientific Meeting September 2008– Institute of Medicine Meeting August 2008• Discuss specifications <strong>and</strong> st<strong>and</strong>ards for metals testing• Which Metals?• Risk Assessment <strong>and</strong> Limit Setting• Modifying Factors for Risk Assessment• Measurements• Scope: drugs, excipients, food, dietary supplements• EMEA Guideline on the Specification Limits for Residues ofMetal Catalysts– <strong>USP</strong> Advisory Panel– Industry Project Team
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