IPECAmericas 2006 January 27, 2006, Orlando, Florida USP UPDATE Roger L. Williams, M.D. Executive Vi - PowerPoint PPT Presentation

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IPECAmericas 2006 January 27, 2006, Orlando, Florida USP UPDATE Roger L. Williams, M.D. Executive Vi

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Title: IPECAmericas 2006 January 27, 2006, Orlando, Florida USP UPDATE Roger L. Williams, M.D. Executive Vi


1
IPEC-Americas 2006January 27, 2006, Orlando,
FloridaUSP UPDATERoger L. Williams,
M.D.Executive Vice President and Chief
Executive Officer
  • Roger L. Williams, M.D.
  • Chair, Council of Experts

2
Topics
  • PDG Update
  • USP Update
  • New Joint IPEC/PQG Excipient GMP Guide
  • USP and IPEC
  • Congratulations!

3
USP Convention Resolution 7 International
Harmonization
  • USP resolves to continue its efforts to
    harmonize compendial standards with the
    Pharmacopeial Discussion Group (PDG) and other
    pharmacopeias.
  • June 2005 Board formed Advisory Body
    (Convention and Council of Experts membership

4
Advisory Body Membership
  • Gregory E. Amidon, Ph.D., Council of Experts
  • Joseph W. Cranston, Ph.D., American Medical
    Association
  • James E. DeMuth, Ph.D., Council of Experts
  • Sidney L. Finn, Ph.D., American Pharmacists
    Association
  • Rita Munley Gallagher, Ph.D., R.N., American
    Nurses Association, Inc.
  • Gordon R. Johnston, R.Ph., Generic Pharmaceutical
    Association
  • Ashok V. Katdare, Ph.D., Expert Committee Member
  • Janeen Kincaid, B.S., Pharmaceutical Research and
    Manufacturers of America
  • Robert King, Ph.D., Food and Drug Administration
  • David R. Schoneker, M.S., IPEC - Americas
  • Marilyn K. Speedie, Ph.D., Chair, Resolutions
    Committee
  • Steven Sutherland, Ph.D., Generic Pharmaceutical
    Association
  • Susan C. Winckler, R.Ph., J.D., American
    Pharmacists Association

5
Advisory Body Meeting October 31, 2005 Issues
  • PDG process is slow
  • Confusion about harmonization definition
  • Pharmacopeial experts rarely meet
  • PDG excluded from ICH and from Q4B
  • PDG work is resource intensive Q4B requests can
    add substantially
  • Decrease in Requests for Revision to USP
  • ROI for public and industry?
  • Impact of PAT

6
Next Steps
  • Letter to PDG with copy to ICH Q4A
  • USP supports PDG harmonization of excipient
    monographs and associated General Chapters
  • USP supports PDG harmonization of non-excipient
    General Chapters, with industry support analogous
    to Tri-PEC support
  • USP supports ICH Q4B Expert Working Group, but
    requests to PDG should be kept to minimum
  • USP understands drug substance monographs are not
    a priority for PDG.
  • Discussion Points (USP statement)

7
Stage 6A Monographs (Chicago NOV-05)
  • Ethyl cellulose
  • Hypromellose
  • Lactose, Anhydrous
  • Lactose Monohydrate
  • Methylcellulose
  • Butyl, Ethyl, Methyl, Propyl Paraben
  • Saccharin
  • Saccharin Calcium
  • Saccharin Sodium
  • Sodium Chloride
  • Sodium Starch Glycolate
  • Starch, Corn
  • Starch, Potato
  • Starch, Wheat
  • Talc
  • Alcohol
  • Alcohol Dehydrated
  • Benzyl Alcohol
  • Calcium Disodium Edetate
  • Calcium Phosphate Dibasic
  • Calcium Phosphate Dibasic (Anhydrous)
  • Carboxymethylcellulose Calcium
  • Croscarmellose Sodium
  • Cellulose, Microcrystalline
  • Cellulose, Powdered
  • Cellulose Acetate
  • Cellulose Acetate Phthalate
  • Citric Acid, Anhydrous
  • Citric Acid, Monohydrate

8
PDG Update (Chicago NOV-05)
  • Q6A General Chapters relating to Microbial
    Contamination
  • Microbial examination of non-sterile products
  • Enumeration test methods lt61gt
  • Tests for specified micro-organisms lt62gt
  • Acceptance criteria for pharmaceutical
    preparations and substances for pharmaceutical
    use lt1111gt

9
Topics
  • PDG Update
  • USP Update
  • New Joint IPEC/PQG Excipient GMP Guide
  • USP and IPEC
  • Congratulations!

10
USP Governing and Advisory Bodies
Council of the Convention (President EVP-CEO,
with advice and consent of BOT)
Convention Membership
Subcommittees (Committee Chair)
Councilof Experts Expert Committees
Board of Trustees Board Committees
USP Staff
Advisory Panels (CoE Chair)
Stakeholder Forums Project Teams
Advisory Bodies
11
USP Convention 2005 Resolutions
  • Public monographs and reference materials
  • Integrity and safety of therapeutic products
  • New science and technology
  • Compounding standards and education
  • Standards for nomenclature and labeling
  • USP international presence
  • International harmonization
  • Drug information programs
  • Promoting safe medication use and disposal
  • Evidence-based methodologies and algorithms for
    decision support used in e-prescribing and
    pharmacy computer systems
  • USP Convention
  • Expanded outreach
  • Organizational outreach

12
2005 2010 USP Officers Trustees
Spirit of Voluntarism
  • President Darrell R. Abernethy, M.D., Ph.D.
  • Treasurer Larry L. Braden, R.Ph., D.Sc.
  • Trustee Representing the Public
  • Carolyn H. Asbury, Ph.D., Sc.MPH
  • Trustees Representing the Medical Sciences
  • Ellen M. Cosgrove, M.D., FACP
  • June E. Osborn, M.D.
  • Trustees Representing the Pharmaceutical Sciences
  • Mary Anne Koda-Kimble, Pharm.D.
  • John W. Mauger, Ph.D. (Chairman)
  • Trustees AtLarge
  • Rene H. Bravo, M.D.
  • Carmen A. Catizone, M.S., R.Ph., D.Ph.
  • Duane M. Kirking, Pharm.D., Ph.D.

13
USPs Strategic Opportunities
14
USPs Organizational Chart
15
USP Standards Development TeamsJanuary 2006
R. Williams, Chair of the Council of Experts,
Acting Chief Standards Officer
T. Cecil, DSD
D. Cousins, DPS
D. Perfetto
N. Blum, IA
Small Molecules Monograph Acquisition
BB
General Chapters
Dietary Suppl.
RAD/VET
Excipients
Drug Information
Medication Safety
Medication Practices
Intl. Health
USP DQI
Intl. Affairs
57 Standards and Information Expert Committees
26 Advisory Panels
P2, USAN, Compendium for Safe Medication Use
M.G., Vol III Annals
USP
NF
Translations
RAD/VET
A. Long VP VOA
Project Management, Meetings Support, Executive
Secretariat/Admin, Stakeholder and Organizational
Affairs, Library
R.Manning VP MRSD
Research and Development Laboratory, BB
Laboratory, Performance Testing
Legal
S. de Mars
R. Wailes
Account Management, Pharmacopeial Education,
Marketing Communications, Website
S. Lane
Reference Standards Operations, Reference
Standards Scheduling and Planning
Editorial and Production
M. Becker
Procurement, Distribution
D. Lutz
Quality Assurance-Enterprise Risk Management
K. Conerly
Infrastructure, IT Support
C. Greiner
Human Resources, Training
E. Martini
16
Organization of the Council of Experts
17
USP-NF Major Transformations
  • Redesign of USP-NF
  • Redesign of PF
  • Enhance Monograph Acquisition
  • Standards for Articles Legally Marketed in Other
    Countries
  • Enhancements to USP Performance test
  • Rewrite General Notices
  • Specific Major lt467gt lt231gt, lt621gt
  • Procedural and Ancillary Materials Standards (B
    and B)
  • Flexible Monographs

18
General Chapters
19
USPNF Official Standards
Core Products
  • New 2006 Edition
  • 88 new and 404 revised monographs
  • Many newly harmonized monographs and General
    Chapters
  • 11 new and 29 revised General Chapters
  • USPNF contains
  • Over 4,000 monographs
  • Over 160 General Chapters

20
USP-NF Spanish Translation
21
USP Pharmacists Pharmacopeia
(soft bound cover)
22
USP Education About Standards
Core Products
Custom courses available
  • Fundamentals of USP Standards
  • Advanced USP Standards
  • Microbiology
  • Titrations
  • Dissolution
  • Analytical Method Validation
  • Statistics

23
USP Reference Standards
Core Products
  • Over 1,800 standards
  • Non-complex active substances
  • Impurities
  • Antibiotics
  • Dietary supplements
  • Products exported to the U.S. which meet USP
    standards will meet requirements of U.S.
    federal law

24
How are Reference Standards Packaged?
  • ISO 9001 processes
  • GMP Compliant

25
USP Ships More Than 5000 Vials a Week
26
ISO Certification
27
Pharmacopeial Forum Your Voice with USP
Core Products
  • Comment on USPNF changes
  • Propose new, alternative, or revised standards or
    test procedures
  • Stay up to date on Interim Revision Announcements

28
USP Dictionary of USAN and International Drug
Names
Core Products
  • International and U.S. drug names
  • Chemical names and structures
  • Other important drug information

29
to Present
Transforming to aBright Future
30
Program Visual
31
USP Sites and Stakeholder Forums (Existing
Planned)
Shanghai (Proposed Site)
Moscow
Basel (Sales Office)
Ottawa
Amman
Washington D.C.
Mexico City
Hyderabad (Site)
Cairo
  • South America
  • Buenos Aires
  • Sao Paolo
  • Santiago
  • Bogotá
  • Caracas
  • La Paz
  • Lima
  • Quito

32
Topics
  • PDG Update
  • USP Update
  • New Joint IPEC/PQG Excipient GMP Guide
  • USP and IPEC
  • Congratulations!

33
USP and IPEC-Americas Guides
  • New Joint IPEC/PQG Excipient GMP guide
  • USP proposed a revision to the lt1078gt information
    chapter in PF28(5) to align it with changes made
    to the IPEC GMP guide in 2001.
  • Both documents reflected the ISO 90012000
    quality system standard.
  • USP plan to further revise lt1078gt to reflect the
    joint initiative between IPEC-Americas and
    Europe, and the PQG, combining the IPEC Good
    Manufacturing Practices Guide 2001 with the PQGs
    PS 91002002 Pharmaceutical excipients.

34
USP and IPEC-Americas Guides
  • USP publications
  • lt1078gt Good Manufacturing Practices for Bulk
    Pharmaceutical Excipients (Official information
    chapter )
  • lt1195gt Significant Change Guide for Bulk
    Pharmaceutical Excipients (PF31(4))
  • lt1080gt Bulk Pharmaceutical Excipients
    Certificate of Analysis (PF31(4))
  • IPEC-Americas guides
  • Good Manufacturing Practices Guide for BPE
  • Significant Change Guide for BPE
  • Certificate of Analysis Guide for BPE
  • Americas Excipient Master File Guide
  • GMP Audit Guide for BPE

35
Topics
  • PDG Update
  • USP Update
  • New Joint IPEC/PQG Excipient GMP Guide
  • USP and IPEC
  • Congratulations!

36
2005-2010 Excipient Expert Committees
  • Excipient General Chapters
  • Gregory E. Amidon, Chair
  • Garnet E. Peck, Vice Chair
  • Excipient Monograph 1
  • Zak T. Chowhan, Chair
  • Ashok V. Katdare, Vice Chair
  • Excipient Monograph 2
  • Lawrence Block, Chair
  • Richard C. Moreton, Vice Chair

37
Excipient Monographs
  • USP 29-NF 24 contains
  • 400 excipient monographs
  • Number of new excipient monographs need to be
    developed
  • 150
  • Number of excipient monograph needing major
    revision
  • 200

38
New Excipients in USP 29-NF 24
  • Carbomer Homopolymer
  • Purified Honey
  • Isomalt
  • Lauroyl Polyoxylglycerides
  • Neotame
  • Propylene Glycol Dilaurate
  • Propylene Glycol Monolaurate
  • Sunflower Oil

39
New Excipients targeted for USP 29-NF 24 1st and
2nd Supplements
  • Tagatose
  • Potassium Alginate
  • Amino Methacrylate Copolymer
  • Ethyl Acrylate and Methyl Methacrylate Copolymer
    Dispersion
  • Erythritol
  • Maltitol
  • Diisopropanolamine

40
Monograph Acquisition Campaign (MAC) USP
Guideline
  • USP Guideline for Submitting Request for Revision
    to the USP-NF
  • Work of the 2000-2005 Expert Committees and the
    Project Teams
  • Chapter 1 Noncomplex Drug Substances and
    Products
  • Chapter 3 Excipients
  • Template for writing a monograph in the USP style
  • websitehttp//www.usp.org/USPNF/submitMonograph/

41
Convention Resolution 12 Organizational Outreach
  • USP resolves to expand its efforts to engage
    stakeholders, who are affected by USP standards,
    but have not been fully involved in USP
    processes, such as Human Biologics, Animal
    Health, Biotechnology, and Device Manufacturers,
    in USP committees and programs
  • Submitted by the Prescription/Non-Prescription
    Stakeholders Forum

42
Prescription/Non-Prescription Stakeholder Forum
Members
  • American Association of Pharmaceutical Scientists
  • Calibration and Validation Group (Canada)
  • Consumer Healthcare Association
  • Food and Drug Administration
  • Generic Pharmaceutical Association
  • International Pharmaceutical Aerosol Consortium
    for Regulatory Science
  • International Pharmaceutical Excipients Council
  • Midwest Compendial Discussion Group
  • New Jersey Pharmaceutical Quality Control
    Association
  • Parenteral Drug Association
  • Pharmaceutical Research and Manufacturers of
    America
  • Pharmaceutical Sciences Group (Canada)
  • Western Compendial Discussion Group

43
Project Team 3 Excipients (2000-2005)
  • Anthony Bevilacqua
  • Edward M. Cohen
  • Huston Howell
  • Ashok V. Katdare
  • Janeen Kincaid
  • Elaine V. Knight (chair)
  • Phil Merrell
  • Richard C. Moreton
  • David R. Schoneker
  • Steve Sutherland
  • Rajendra Uppoor
  • Sigita Zibas

44
Project Team 3 - Highlights
  • Helped develop Chapter 3 Excipients in the
    USP Guideline for Submitting Requests for
    Revision to USP-NF
  • Prioritized the list of missing excipient
    monographs/excipient database
  • Worked on packaging and storage issues with the
    Packaging, Storage, and Distribution Expert
    Committee

45
Project Team 3 Future Opportunities
  • Excipient verification/qualification
  • Certificate program
  • Explore the relationship between excipient food
    additives and pharmaceutical excipients
  • Role of USP in helping FDA in the drug
    counterfeit and bioterrorism areas
  • NF monographs when no NF-grade suppliers are
    available
  • Review and revise, as needed, General Chapter
    lt1078gt Good Manufacturing Practices for Bulk
    Pharmaceutical Excipients based on the new joint
    IPEC/PQG Excipient GMP Guide

46
Project Team 3 IPEC-Americas
  • IPEC Americas USP Liaison Committee
  • Dave Schoneker
  • Janeen Kincaid
  • Rick Green
  • Eunice Cuirle
  • USP Liaison
  • Catherine Sheehan

47
ASM 2006 Denver, Colorado, September 27-29
Meeting Tracks
  • Biologics and Biotechnology
  • Excipients
  • Dietary Supplements
  • Making USPNF Work for You
  • Reference Standards
  • Impurities in Drug Substances and Products

48
ASM 2006 Denver, Colorado, September 27-29
  • Excipients Sessions
  • Performance Tests in Excipients
  • Performance Tests in Excipients
  • Additives and Impurities in Excipients
  • Development of New Excipient Technologies
  • Drug/Excipient Interaction

49
Topics
  • PDG Update
  • USP Update
  • New Joint IPEC/PQG Excipient GMP Guide
  • USP and IPEC
  • Congratulations!

50
Congratulations!
  • USP Shared in the Beginning of IPEC at the
    January 1991 USP Open Conference in Orlando,
    Florida
  • Lou Blecher
  • Henk de Jong
  • Others
  • Congratulations to IPEC for 15 productive years
    and many more to come.

51
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