USP Monograph Development Process and Compendial Updates

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General Notices Revision• Timeline– May-Aug 2007: first draft published on USP websitefor comments– Jan-April 2008: Second draft in PF 34(1) and on theweb site; comment period ended April 15, 2008– Spring 2008: Final draft approved (Phase I)– Nov 2008: USP32-NF27 is published with Phase Irevisions– May 1, 2009: USP32-NF27 becomes official
General Notices Phase I Revisions• Legal Status of USP (partial revision)• Definition of units to be taken – eliminated• Compliance to GMPs – partially retained (notcGMP)• ICH’s 0.10% impurity level (instead of 0.1%) notincorporated, yet…• USP will not define testing intervals or define thesize of a “representative” sample• Compliance to water standards outside the USare not specifically addressed• Equivalent or better is required for alternativeprocedures• “Must pass if tested” text strengthened
Page 1 and 2: Quality Standards for Medicines, Su
Page 4 and 5: United States PharmacopeialConventi
Page 6 and 7: Legal Recognition1848 Drug Import A
Page 9 and 10: 2005-2010 Council of ExpertsFood Ad
Page 11 and 12: 2005-2010 Expert Committee Demograp
Page 13 and 14: Why a USP-NF Monograph?• Recogniz
Page 15 and 16: Submission Information on Web Site
Page 17: USP Standards Setting ProcessMonogr
Page 20 and 21: Role of USP Expert Committees• Ev
Page 22 and 23: Flexible Monographs: Examples• Et
Page 24 and 25: Flexible Monograph ExampleTheophyll
Page 26 and 27: USP PublicationsFood Chemicals Code
Page 28 and 29: USP Reference Standards
Page 30 and 31: USP RS Development Process1. Create
Page 32 and 33: Compendial Updates
Page 34 and 35: Monograph Redesign• Well defined
Page 36 and 37: Monograph Redesign
Page 38 and 39: General Notices Redesign• Ease of
Page 42 and 43: Major Issues for Phase II• Issues
Page 44 and 45: Pending Monographs• Sponsors- Who
Page 46 and 47: PF Redesign• Current situation- D
Page 48 and 49: PF Redesign• Remove official text
Page 50 and 51: PF Redesign• Redesign USP-NF Web
Page 52 and 53: PF Redesign• September 2008: ASM
Page 54 and 55: Residual Solvents• Organic Volat
Page 56 and 57: Residual Solvents• Classes of res
Page 58 and 59: Educational Activities• Residual
Page 60 and 61: Heavy Metals• USP is actively see
Page 62 and 63: Compendial Toolshttp://www.usp.org/
Page 64 and 65: Column Equivalency
Page 66: Quality Standards for Medicines, Su

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