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VIEWS: 5 PAGES: 43

									Quality Standards for Medicines, Supplements, and Food Ingredients throughout the World




       IDMA/Stakeholder Forum
               IPC/USP
      9th Annual Science Meeting
               Mumbai
          February 18-19, 2010

    Role of the Compendia: USP

        Roger L. Williams, M.D.
    CEO and Chair, Council of Experts
Optimal Approaches
        About the Phoenicians …

The ancient Phoenicians invented a primitive BALANCE
    made from wood and cloth to assure equity in trade
USP Reference Standards



              USP offers more than 2,500 Reference
               Standards for use in the full range of
               USP–NF tests and procedures
              USP Reference Standards are highly
               characterized specimens of
                   drug substances         dietary supplements
                   excipients              compendial reagents
                   impurities              performance
                   degradation products     test tablets


              USP Reference Standards have been
               rigorously tested by USP, industry,
               and government scientists
USP Documentary & Reference Standards

       Materials         Procedures
Food and Drug Administration
Realms of Specifications &
Measurements
                           Acceptance Criteria



                           Release Specifications



                                                     Manufacturing
                               Process Variability




  Analytical Measurement and
          Uncertainty


                                                     Measurement
         Certified Reference Material




                                “Trueness”
Food Chemicals Codex

            The comprehensive reference for purity and
               quality standards for food-grade substances:
            preservatives, flavorings, colorings,
            and nutrients.
             Monographs provide essential data: formulas,
              description, identification, function, assay,
              physiochemical characteristics, residual
              solvents,
              packaging and storage
             Internationally recognized
             Published once every two years, with
              annual supplements in between editions
             Hardcover print and online formats,
              English only
Needle in a Haystack


  How did
 you find it?
                        How will you
                       prevent it from
                         happening
 How will you              again?
 find another
     one?
From Old to New: A Success Story

Monograph        Old USP            Old EP                    New USP
Requirement
Identification   • Flame test for   • Sheep plasma clotting   • Proton NMR
                   sodium           • Optical rotation        • Anion Exchange
                                    • Zone electrophoresis      Chromatography
                                    • Residue on ignition     • Anti-Factor Xa to
                                                                anti-Factor IIa Ratio
                                                              • Flame test for
                                                                sodium

Assay            • Sheep plasma     • Sheep plasma clotting   • Chromogenic
                   clotting                                      anti-Factor IIa
Situation: USP Monographs

             Exhibit 1: USP Monograph Status

                        212, 4%
                 583, 10%




                                                    2965, 52%

          1960, 34%



       Official, Acceptable            Articles w/o Monographs
       Official, Need Updating         New, Not Yet Official
      Note: Total USP Monograph Universe = 5720, as of June 23, 2009
                              USP Monograph Market Status

                                                                                                Total USP
                                                 423, 7%                                        Monographs: 5929




                  1720, 29%



                                                                                               3427, 58%



                                   359, 6%


                            Official, No Revision in Process*                 Official, Revision in Process**
                            Articles w/o Monographs*                          New, Not Yet Official*
* Source: SWS monograph advanced search MD/RM, Vet Committees.
** Source: SWS RTS advanced search MD, RM, Vet Committees, Status Revision.                                     Date: June 30, 2009
                             USP Monograph Market Status

                                                                                            Total USP
                                                  404, 7%                                   Monographs: 5930




                  1671, 28%



                                                                                            3404, 57%



                                   451, 8%


                            Official, No Revision in Process*             Official, Revision in Process**
                            Articles w/o Monographs*                      New, Not Yet Official*
* Source: SWS monograph advanced search MD/RM, Vet, B&B Committees
** Source: SWS RTS advanced search MD, RM, Vet, B&B Committees, Status Revision.                            Date: December 13, 20
Identity Confirmation

Every pharmaceutical ingredient, formulated product, together with its
packaging materials has unique characteristics or “fingerprints” that can
be probed using various regions of the electromagnetic spectrum.
Allied Compendial Programs


Verification Programs
• USP Dietary Supplement Verification Program
  (DSVP)
• USP Dietary Ingredient Verification Program (IVP)
• USP Pharmaceutical Ingredients Verification
  Program (PIVP)
Allied Compendial Programs, cont.


Pharmacopeial Education
• USP scientists teach USP methods
  for quality control, product release
  testing, and regulatory compliance.
• Courses in multiple
  languages, including
  Spanish, German,
  and French.
USP Convention’s Membership Meeting




                        April 21-24, 2010

                     Grand Hyatt Washington
                       1000 H Street, N.W.
                        Washington, DC
    USP – Convention Composition
       Colleges and Schools of Medicine and
       Pharmacy, State Medical and
       Pharmaceutical Societies and                            60%
       Associations




ManufacturesDi
stributors,
Trade and
Affiliated                  5%
Associations                       5%                                                          15%
(up to 25)                                    5%           5%            5%

   Non-U.S. International
   Organizations and                                                                                National and State Professional
   Pharmacopeias              U.S. Government                           Consumer                    and Scientific Associations
   (up to 25)                 and Five Foreign       Members At         Organizations and           (up to 75)
                              Governments            Large              Persons Representing
                              (up to 25)             (up to 25)         the Public Interest
                                                                         (up to 25)


                        (does not include Board of Trustees, honorary , ex-officio members, or committee members)
2005-2010 USP Council of Experts




                           Food Ingredients
                           Expert Committee
         2010-2015 Expert Committees and Expert Panels
                          Model Guidelines                  Executive                      Scientific           International
                           (as necessary)                                                Advisory Group        Health Advisory
                                                            Committee                    (Resolution 3)            Group



                                                            USP
 S. Becker                Small Molecules: K. Russo                         Large Molecules: Tina Morris                 B. Jones

Nomenclature,                                                               B&B                  B&B                      Reference
                      Small                Small
 Safety, and                                                             Monographs 1         Monographs 2                Standards
                    Molecules            Molecules
  Labeling
                   Monographs 1         Monographs 2


                      Small                Small
                    Molecules            Molecules
                   Monographs 3         Monographs 4



                                                  General Chapters: A. DeStefano


   Toxicology       Statistics         Physical        Chemical         Biologics        Dosage
                                       Analysis        Analysis                                           Microbiology      Packaging
                                                                        Analysis         Forms



                    NF                       DS                         FCC                          P2
                 J. Griffiths                J. Griffiths                 J. Griffiths             S. Becker

                                                DS                          Food
                Excipients                   Monographs                  Ingredients               Compounding
100+ Volunteers are from 31 Countries

   •   Argentina   1    •   Italy             2
   •   Austria     2    •   Jordan            1
   •   Australia   1    •   Mexico            2
   •   Belgium     3    •   The Netherlands   1
   •   Brazil      2    •   Norway            1
   •   Canada      22   •   Peru              2
   •   Chile       1    •   Panama            1
   •   China       4    •   Russian Fed       11
   •   Colombia    2    •   Scotland          1
   •   Denmark     3    •   S. Africa         1
   •   France      2    •   S. Korea          2
   •   Germany     3    •   Sweden            3
   •   Hungary     1    •   Switzerland       4
   •   India       26   •   UK                18
   •   Ireland     1    •   Venezuela         1
   •   Israel      1
         Call for Candidates: 2010-2015 Council of
         Experts

                            Science, Innovation, Passion, Commitment:
                            You Set the Standard
                                • Influence Drug Quality
                                • Utilize Your Expertise
                                • Advance Your Profession
                                • Improve Public Health
                            Visit the USP Web site to apply or to
                            recommend a candidate:
                                 >   www.usp.org/goto/nominate
                            Deadlines:
                               • December 31, 2009: Chair
                                   applications
                               • May 15, 2010: Expert Committee
                                   Member applications
                               • Starting in July 2010: Expert Panel
                                   recruitment

EA007S
Important Dates

•   December 18, 2009: Deadline for CoE (Chair) applications
•   January 31-February 1, 2010: Nominating Committee Meets
•   April 20-24, 2010: CoE Elected at the USP Convention
•   May 15, 2020: Deadline for Expert Committee Member
    Applications
•   June 14-15, 2010: CoE Orientation, Expert Committee member
    elections
•   June 2010: USP 34-NF 29 ballot—2005-2010 ECs
•   Late-June; Early July 2010: CoE Training (Web)
•   June 30, 2010 and July 1, 2010: Turn off-turn on dates
•   July 2010-September 2010: First EC meetings
•   October 2010: USP 34-NF 29 Supplement 1 ballot—2010-2015
    ECs
2005-2010 Board of Trustees Strategic Plan


1. Expand and enhance USP’s core
   compendial activities
   – Documentary standards and reference
     materials for medicines and food ingredients
2. Build and strengthen USP’s allied
   compendial programs
   –   Education programs
   –   Verification programs
   –   Technical assistance in developing countries
   –   Anti-counterfeiting programs
2005-2010 Board of Trustees Strategic Plan


3. Engage in other public health programs
   that fulfill unmet needs and leverage
   USP’s unique capabilities
4. Operate nationally and internationally to
   help improve the quality, safety, and
   benefit of medicines and foods worldwide
5. Manage all USP programs, products, and
   services to maximum impact
USP’s International Activities
             USP World       North         Latin         West         East    Middle East, Sub-Saharan     South Asia      East Asia
                Region      America      America/       Europe       Europe   North Africa    Africa                       (Pacific)
                                         Caribbean                    (CIS)     (MENA)


Partners                     USP
                                            Brazil       Basel                                               India            China
                            Rockville
                                             Site         Site                                                Site             Site
                              HQ

US FDA International      Rockville     Mexico        Belgium, UK,                                          India (2)   China (3)
Offices                                 Costa Rica    Italy
Ministries of Health/     MOU-Health    PAHO          MOU-NIBSC MOU-          MOU          African                      MOUs
Regulatory/Regional       Canada        MOU-FEUM                Russia        Jordan FDA   Medicines                    China SFDA
Authorities                             WHO                     Roszdravn-                 Reg. Harmon.                 Sing. HSA
                                                                adzor                      Initiative
                                                                                                                        ASEAN RSWG
                                                                                           (Develop.)
                                                                                                                        Vietnam
Official Medicines                      PANDRH                                                                          MOUs-China
Control Laboratories                                                                                                    Provincial/
(OMCLs)                                                                                                                 Municipal
                                                                                                                        Agencies

Pharmacopeial                                                                                             MOU-IPC       MOU
Commissions                                                                                                             ChP
Manufacturers                           MOU-
                                        Sindusfarma



                        -Convention Membership/Observer                          -Stakeholder Forum/National ASM
                        -Agency (MOUs, Outreach, Standards)                      -Marketing & Sales
                        -OMCLs (MOUs, Outreach, Standards, Proficiency,          -USAID/Contracts
                         Accreditation)                                          -Verification
                        -Invitation to Primary ASM                               -Education/Training
USP Global Laboratory Sites

                          China




                                  India



       Rockville,
       Maryland          Brazil
29
USP India Advisory Group


•   Mr. Humayun Dhanrajgir
•   Dr. S S Vara Prasad
•   Prof. Dr. B. Suresh
•   Dr. Sen Gupta
•   Dr. Ajit Dangi
•   Mr. Homi R. Khusrokhan
•   Dr. V Prakash
•   Dr. Ajit Singh
•   Dr. Vinay Nayak
•   Many others over the years!
USP India Stakeholder Forum

•   Industry Representative, Mr. Ajit Singh (Chair)
•   Indian Pharmaceutical Association (IPA), Dr. S.D. Joag
•   Indian Drugs Manufacturers Association (IDMA), Mr. Dara Patel
•   Indian Drugs Manufacturers Association (IDMA), Mr. N. R. Munjal
•   Pharmacy Council of India (PCI), Dr. B. Suresh
•   Confederation of Indian Industry (CII), Dr. Sen Gupta
•   Industry Representative, Dr. Milind Joshi
•   Deputy Drugs Controller of India—West Zone, Dr. Ramakrishna
•   Federation of India Chambers of Commerce and Industry (FICCI),
    Bhagirathi Mohan
•   Dr. Venkat Mukku, Global Cellular Analytic Solutions, and USP Expert
    Committee Member
•   LG Promochem, Mr. B. R. S. Rao
•   CFTRI, Federal Govt. Labs , Dr. V. Prakash
What’s Next?

• FDA
• Government of India
   – Ministries
   – State Governments
   – DGI India
   – Indian Pharmacopoeia Commission
• Indian Manufacturers/Associations
• Practitioners
   – Pharmacy Council
   – Medical Counci
   – Othersl
• CII, FICCI, AssoCham
• Many Others
USP Convention Headquarters
USP Convention White Papers Available




                        WHITE PAPERS

1.   USP’S ROLE IN SETTING ENFORCEABLE QUALITY STANDARDS FOR
     MEDICINES
2.   A MODEL SYSTEM TO PROMOTE ACCESS TO GOOD QUALITY
     COMPOUNDED MEDICINES
3.   USP’S ROLE IN PATIENT SAFETY
4.   ACCESS TO GOOD QUALITY DIETARY SUPPLEMENTS
5.   OPPORTUNITIES FOR DRUG INFORMATION AND USE STANDARDS
6.   IMPORTANCE OF STANDARDS IN ASSURING GOOD QUALITY FOOD
     INGREDIENTS AND FOODS
7.   USP’S ROLE IN ASSURING GLOBAL ACCESS TO QUALITY MEDICINES
ASM moving to 2011




                     EXE07S_1009
USP’s B and B Strategic Landscape
USP’s Food Ingredients Strategic
Landscape
            NF/Excipient Monograph Market Status

                                                                                          Total NF
                                               47, 9%                                     Monographs: 507



                       92, 18%
                                                                                  211, 42%




                                     157, 31%

                            Official, No Revision in Process*    Official, Revision in Process**
                            Articles w/o Monographs*             New, Not Yet Official*

* Source: SWS monograph advanced search MD/RM, Vet Committees.
            NF/Excipient Monograph Market Status

                                                                                         Total NF
                                                44, 8%                                   Monographs: 521



                      103, 20%
                                                                                 204, 39%




                                        170, 33%

                            Official, No Revision in Process*   Official, Revision in Process**
                            Articles w/o Monographs*            New, Not Yet Official*

* Source: SWS monograph advanced search Exc. Committees.
             Dietary Supplements Monograph Market Status

                                                                                              Total DS
                                           75, 13%                                            Monographs: 577




                                                                                       261, 45%
                    146, 25%




                                                 95, 17%

                            Official, No Revision in Process*        Official, Revision in Process**
                            Articles w/o Monographs*                 New, Not Yet Official*

* Source: SWS monograph advanced search DS Committees.
** Source: SWS RTS advanced search DS Committees, Status Revision.                                 Date: December 13, 20
                            FCC Monograph Market Status

                                                                                         Total FCC
                                                      27, 1%                             Monographs: 1806




                   692, 38%

                                                                                  877, 49%




                                           210, 12%

                          Effective, No Revision in Process*   Effective, Revision in Process**
                          Articles w/o Monographs*             New, Not Yet Effective*
*Source:sws monograph advance search FCC
Major Advancements of the Cycle
   • General Notices (Project Team)
   • Monographs
      – Flexible
      – Pending
      – Performance-based
      – Non-US
   • General Chapters (Project Team)
      – Charts/Stimuli Article
   • Adulteration/Contamination/Impurities
      – Heparin, Glycerin, Other High-Risk Articles
      – Residual Solvents/Metal Impurities
   • Performance Test/Performance Verification Test
   • Certified Reference Materials
   • Process Improvements

								
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