USP Monograph Development Process and Compendial Updates

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Heavy Metals• USP is actively seeking industry input– USP Annual Scientific Meeting September 2008– Institute of Medicine Meeting August 2008• Discuss specifications and standards for metals testing• Which Metals?• Risk Assessment and Limit Setting• Modifying Factors for Risk Assessment• Measurements• Scope: drugs, excipients, food, dietary supplements• EMEA Guideline on the Specification Limits for Residues ofMetal Catalysts– USP Advisory Panel– Industry Project Team
Heavy Metals--TimelineSummer2008August2008Sept2008Dec2008Jul-Aug2009August2009Oct2009June2010StimuliArticle fromAdvisoryPanelPosted onwebIOMMetalsToxicologyWorkshopWashington,D.C.Stimuli ArticlePF 34(5) Sept-Oct 2008AnnualScientificMeetingImpuritiesSessionStim articlecommentperiod endsAdvisoryPanel meetsDraftChapterPublishes inPF 35(4)Ref Stds(s)bulks inhouseHeavyMetals WebMeetingsforpublic dialogOct. 15commentperiod endsAdvisoryPanel meetsChapterpublished inSupplement 2to USP 33Dec. 2010Delayed officialdate: ?Ref Stds(s) incatalogDeadlines Dec 15, 2008 Mar 20, 2009Oct 2009 Feb 20102010—General Chapter PublishedOfficial Date to be determinedExpert Committee: General Chapters, James DeMuth, ChairAdvisory Panel: Heavy Metals, Nancy Lewen, ChairProject Team: Heavy Metals and Inorganic Impurities, Fran Byrne, Chair= Where We Are on Timeline
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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 40 and 41: General Notices Revision• Timelin
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 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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