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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Major Issues for Phase II• Issues– Change the name of <strong>USP</strong>-NF? (e.g, <strong>USP</strong>-NF 2011)– <strong>Development</strong> of a companion volume– Merging of General Notices across publications– Definition of “Official”– Definition of performance-based procedures <strong>and</strong> tests• Ongoing discussions with Expert Committees,FDA, stakeholders
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