USP Monograph Development Process and Compendial Updates

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Pharmacopeial Forum• Your voice in standardsdevelopment• Bimonthly journal with– Proposed revisions to USP-NFstandards for your comments– Official revisions to standards– Updates on internationalharmonization– Stimuli articles
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 21 and 22: Flexible Monographs: Rationale• F
Page 23 and 24: Flexible Monograph ExampleLoratadin
Page 25 and 26: USP Publications• Time-tested,int
Page 27 and 28: USP PublicationsUSP Dietary Supplem
Page 29 and 30: USP Reference Standards• Trusted
Page 31 and 32: Reference Standards Practices• Al
Page 33 and 34: Monograph Redesign• Fewer words,
Page 35 and 36: Monograph Redesign Timeline• June
Page 37 and 38: Monograph Redesign Example
Page 39 and 40: General Notices RevisionExcerpt fro
Page 41 and 42: General Notices Phase I Revisions
Page 43 and 44: Pending Monographs• Enables monog
Page 45 and 46: Pending Monographs ProcessMonograph
Page 47 and 48: PF Redesign• Transition to on-lin
Page 49 and 50: PF Redesign• Standardize and simp
Page 51 and 52: PF Redesign• Outstanding Issues-
Page 53 and 54: USP31-NF26 General Notices TextResi
Page 55 and 56: Residual Solvents• Testing of dru
Page 57 and 58: Proposal - PF34(3) [May-June 2008]T
Page 59 and 60: Heavy Metals• Significant impact
Page 61 and 62: Heavy Metals--TimelineSummer2008Aug
Page 63 and 64: Uniformity of Dosage Form Calculato
Page 65 and 66: Column Equivalency

USP Monograph Development Process and Compendial Updates

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