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USP Monographs

6 th Annual Science and Standards Symposium January 16, 2013 Istanbul. USP Monographs. Roger L. Williams, M.D. CEO/Chair, Council of Experts. Topics. The Basics Management The Future—Science The Future—Putting It Together. Assignments. Documentary Standards-setting Process.

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USP Monographs

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  1. 6th Annual Science and Standards SymposiumJanuary 16, 2013 Istanbul USP Monographs Roger L. Williams, M.D. CEO/Chair, Council of Experts

  2. Topics • The Basics • Management • The Future—Science • The Future—Putting It Together

  3. Assignments

  4. Documentary Standards-setting Process

  5. Expert Committee Participation by Compendium

  6. Expert Committee Participation by Monograph Initiative

  7. Accelerated Revisions by Compendium

  8. Topics • The Basics • Management • The Future—Science • The Future—Putting It Together

  9. Key Elements of Science & Standards Division: Organization Flow

  10. Drivers for Change • Increase/improve interface between different parts of USP • Increase efficiency on work flow within SSD • External to USP • Internal within USP • Expert Committees were recently restructured to manage monographs and reference standards • To make project ownership for each product clear (single point of accountability in the context of the team) • Maximize capacity of our work load (identify constraints and provide solutions)

  11. Drivers For Change: Outcomes • Products (monographs, reference materials) to our customers are synchronized and reference standards are available as early as possible • There is a portfolio owner for each segment of the portfolio for Small Molecules, Biologics, Excipients, Dietary Supplements, Food Ingredients, General Chapters/Pharmacists’ Pharmacopeia, Healthcare Quality Standards • A uniform criteria for priority setting.

  12. Missing from Total Monograph Compendium Expert Committee Compendia (Estimate) Universe (Estimate) In Compendia Small Molecules 3529 1513 5042 USP Biologics 118 297 415 204 Pharmacy 99 105 3746 1937 5661 USP Total 66% 34% Excipients 400 163 563 NF 71% 29% Dietary Supplements 409 1091 1500 DS 27% 73% Food Ingredients 1140 2535 3675 FCC 31% 69% Total 5695 5726 11399 Modernization New Monographs Work in Compendium Expert Committee Needed Process Work in Process Small Molecules 2600 419 214 Biologics 44 0 61 USP 46 Pharmacy 0 0 2644 419 324 USP Total 70% 11% 17% Excipients 96 62 36 NF 24% 16% 22% Dietary Supplements 100 24 83 DS 24% 6% 8% Food Ingredients 250 34 54 FCC 22% 3% 2% Total 3090 539 608 Current Status for US Compendia

  13. Current Status: OTC Modernization (Focus for FY’13)

  14. New Monograph Breakdown (As of April 30, 2012) 10 Small Molecules (USP) 7% Biologics (USP) 41 Pharmacy (USP) 28% 48 Excipients (NF) 32% 2 Foods (FCC) 1% 32 Dietary Supplements (DSC) 6 10 21% Medicines Compendium 4% 7% Pending Monographs Received by Portfolio Category

  15. Reference Standards: Pipeline vs. Process

  16. Reference Standard Lot Releases Note: This information is updated from what appeared in briefing materials.

  17. Topics • The Basics • Management • The Future—Science • The Future—Putting It Together

  18. Drug Product Monographs and General Chapters

  19. Performance Based Monograph • A PBM can include: • Specified tests • Identification, Assay, others • Specific acceptance criteria • 97%-103%, NMT 0.1%, others • Criteria-based procedures with: • Procedure Performance Measures (Precision, accuracy, others) • Procedure Performance Acceptance Criteria (% RSD, Bias, R2, others)

  20. Glutathione Example: Assay

  21. PPMs and PPACs • USP General Chapter Validation of Compendial Procedures <1225> defines the critical validation parameters necessary to validate a procedure. • Pre-set criteria assure that an acceptable procedure will reliably assess whether an article meets acceptance criteria of its Tests. • USP now terms these criteria as Procedure Performance Measures (PPM) and the Procedure Performance Acceptance Criteria (PPAC). • PPM and PPAC may be used to determine suitability of multiple acceptable procedures.

  22. References • Small Molecules Collaborative Group, Williams RL, Abernethy DR, Koch WF, Hauck WW, Cecil TL. Performance-based monographs. Pharm Forum. 2009;35(3):765-771. • Hauck WW, DeStefano AJ, Cecil TL, Abernethy DR, Koch WF, Williams RL. Acceptable, equivalent, or better: approaches for alternatives to official compendial procedures. Pharm Forum. 2009;35(3):772-778. • Koch WF, Hauck WW, de Mars SS, Williams RL. Measurement science for food and drug monographs: toward a global system. Pharm Res. 2010;27:1203-1207. • Williams RL, de Mars S, Koch WF, Hauck WW, Cecil TL. USP responses to comments on Stimuli article: performance-based monographs. Pharm Forum. 2010;36(4):1074-1079.

  23. USP Medicines Compendium: www.usp-mc.org

  24. Key Points About the Medicines Compendium • MC is applicable to medicines legally marketed outside of the US; USP-NF covers articles legally marketed in the US • Science based • Authoritative, not official; the approval by the Council of Experts makes it authoritative • Supplements donor model • Helps modernize USP-NF • Experimental, unique, and innovative

  25. USP Medicines Compendium Process

  26. Topics • The Basics • Management • The Future—Science • The Future—Putting It Together

  27. CompendialGlobalization (Merck)

  28. Pioneers and Harmonization

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