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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Why a <strong>USP</strong>-NF <strong>Monograph</strong>?• Recognized under the Federal Food, Drug, <strong>and</strong>Cosmetic Act• Assessing quality of drug products in commercialdistribution over their shelf life• Monitoring for counterfeit products <strong>and</strong> quality ofimported drug products• Data-driven• Transparent processes with public review <strong>and</strong>comment• Reviewed <strong>and</strong> approved by <strong>USP</strong> Council ofExperts• Continuous revision• Supported by General Chapters <strong>and</strong> GeneralNotices
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