6 th Annual Science and Standards Symposium January 16, 2013 Istanbul USP Compendial Updates Angela...
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6th Annual Science and Standards SymposiumJanuary 16, 2013Istanbul
USP Compendial Updates
Angela G. Long, M.S.Senior Vice President, Global Alliances and Organizational Affairs/Executive Secretariat
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USP Mission and Overview USP Council of Experts USP’s Core Compendia and Reference Materials Compendial Updates USP in the World How to Get Involved with USP
Topics
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USP’s Mission
To improve the health of peoplearound the world through public standards
and related programs that help ensurethe quality, safety, and benefit of
medicines and foods.
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USP – An Overview
Since 1820, nonprofit, private, independent, and self-funded
Headquartered in Rockville, Maryland; 700+ employees; facilities in India, China, Switzerland, Brazil, and Ethiopia
Expert volunteers are scientific decision-makersInternationally recognized and globally focused
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USP’s Statements on Standards
Modern public standards should exist for all medicines and foods
Public standards play a key role in ensuring quality, safety and benefit by allowing independent testing
USP standards are science-based and data-driven USP is not involved in market access or regulatory
approval decisions USP RS may have multiple compendial uses, and are
made available to the public without restriction USP works in many ways to promote harmonization USP partners with pharmacopeias and regulatory
authorities throughout the world to support their work and increase availability of public standards
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USP and NF are Official Compendia
USP is cited in law…1848: Drug Import Act
1906: 1906 Pure Food and Drugs Act
1938: Food, Drug and Cosmetic Act– Definition of a drug
– Adulteration
– Misbranding
– Drug product name
1994: Dietary Supplement Health Education Act
2003: Medicare Modernization Act (Model Guidelines for Medicare Formularies)
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2010–2015 USP Council of Experts
7
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• 861 expert volunteers serving on 24 Expert Committees and 65 Expert Panels
• 366 Expert Committee members• 372 Expert Panel members*
• 123 Government Liaisons– 111 FDA Liaisons
– CDER: 76 ─ CVM: 6– CFSAN: 13 ─ ORA: 3– CBER: 12 ─ CDRH: 1
– 3 Chinese Pharmacopoeial Commission Representatives– 1 European Food Safety Authority Representative– 2 Health Canada Representatives– 1 Indian Pharmacopoeial Commission Representative– 1 NIST Representative– 3 Brazil (ANVISA, Brazilian Pharmacopoeia, INCQS)– 1 CCAYAC/COFEPRIS (Mexico)
2010-2015 Council of Experts - Demographics
* This number does not include Expert Committee members also serving on Expert Panels.
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• 738 Expert Committee and Expert Panel members– 216 (29%) international experts from 34 countries:
1. Argentina 2
2. Australia 3
3. Austria 2
4. Belgium 4
5. Brazil 8
6. Canada 25
7. Chile 2
8. China 32
9. Colombia 2
10. Costa Rica 1
11. Denmark 7
12. France 10
13. Germany 20
14. India 42
15. Israel 2
16. Italy 4
17. Japan 1
2010-2015 Council of Experts - Demographics
18. Jordan 2
19. Mexico 4
20. Netherlands3
21. Peru 2
22. Portugal 2
23. South Africa1
24. Saudi Arabia1
25. Scotland 1
26. South Korea1
27. Spain 1
28. Sweden 2
29. Switzerland8
30. Taiwan 1
31. Ukraine 1
32. United Kingdom 21
33. Uruguay 1
34. Venezuela1
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Core USP Compendia
1. The United States Pharmacopeia
2. National Formulary (USP–NF)
3. Food Chemicals Codex (FCC)
4. USP Dietary Supplements Compendium (DSC)
5. USP Medicines Compendium (MC)
6. USP on Compounding
7. Coming soon: Herbal Medicines Compendium (HMC)
Other Resources
– Pharmacopeial Forum (PF)– FCC Forum (FCCF)– USP Dictionary– Chromatographic Columns
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USP Reference Standards
Trusted for pharmaceutical quality control worldwideOver 2,900 Reference Standards now availableSupport FDA-enforceable standards and tests in
the USP–NF Highly pure, with purity values provided for quantitative standardsStocked and ready to ship same day
(2-day delivery within U.S.)
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USP–NF Translations
Spanish Translation Russian Translation
In the works…Chinese Translation
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USP Medicines Compendium: www.usp-mc.org
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Unique Aspects of the Medicines Compendium
Web-based, online only; open access to documentary standards, including general chapters
Performance Based Monographs with USP-developed Reference Procedures
Use of Certified Reference Materials for assays; Reference Standards for Impurities
Public availability of the validation data Monographs for some medicines that have never before had
public monographs MC Expert Committees meet in USP global regions MC Expert Committee adopts USP-NF general chapters
including some general chapters that are planned or proposed in USP-NF but not yet official, e.g., <232> and <233> for elemental impurities
Simplified, easy to access
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Compendial Updates
Elemental Impurities (General Chapters <232> and <233>) postponement
Other USP Key Issues Proposed Changes to General Notices USP Response to the Compounding Crisis in the US—
methylprednisolone acetate Monograph Naming Policy Publications Enhancements
• Searchable Errata• Future: Publications 2.0
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Elemental Impurities Postponement
http://www.usp.org/usp-nf/official-text/revision-bulletins/elemental-impurities-limits-and-elemental-impurities-procedures
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Watch for Updates on the Key Issues Page
http://www.usp.org/usp-nf/key-issues/elemental-impurities
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USP’s Key Issues
http://www.usp.org/usp-nf/key-issues
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Proposed Revisions to General Notices
http://www.usp.org/usp-nf/notices/proposed-revisions-general-notices-and-requirements-published-comment-pharmacopeial-forum-391-jan-feb-2013
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USP’s Response to the Compounding Crisis
http://www.usp.org/usp-healthcare-professionals/compounding
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Monograph Naming Policy, May 1, 2013
http://www.usp.org/usp-nf/development-process/compendial-nomenclature/monograph-naming-policy
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Monograph Naming Policy, Official May 2013
Drug product monograph titles will include only the active moiety
Strength also will be expressed in terms of the active moiety
The names and strengths of both the active moiety and specific salt form (where applicable) are provided elsewhere on the label
Included in General Chapter <1121> Nomenclature
Finalized 2007; Official May 1, 2013
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Improvement: Searchable Errata
http://www.usp.org/usp-nf/official-text/errata
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Pubs 1.0 Delivery
USP
1. Multiple delivery platforms, but optimized for print.2. Forum is independent. Feedback through private email
to liaison.3. All customers and staff see the same thing.
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Pubs 2.0 Delivery
1. Delivery optimized for each of multiple platforms.2. Forum is integrated. Feedback can be private or public.3. Different customers may see different content,
dependent on subscriptions or personalization.
USP
xml
USP Food Chemicals Codex
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PF Publications
Currently– A PF issue is published every 60 days and has a 90-day public review and
comment period
– Current publication schedule results in overlapping comment periods (i.e., the first 30 days and last 30 days overlap with other issues of PF)
– For USP staff, there are overlapping deadlines with no room for adjustments
Proposed Change– Change from six to four PF issues per year, each with its own 90-day comment
period: Feb, May, Aug and Nov
– Implement in 2014 at the earliest
Benefits– Eliminates overlap allowing each PF to have its own uninterrupted comment period
– Eases internal processes
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Current USP-NF Book and two Supplements are published each year based on six PF issues
Takes 16 to 18 months for a PF proposal to reach the official date of the original target publication (assuming no deferral)
Proposed Change Online USP-NF becomes the primary publication and consider options for print publication(s)
Change from six to four PF issues each year and ballot Expert Committees after each PF therefore four official updates per year
Incorporate Accelerated Revisions into the four official publication
Implement in 2014 at the earliest (change to PF schedule); details are evolving regarding the changes to the official publication schedule
Benefits Shorten time from initial PF proposal to official date estimate is about 13 months, assuming no
deferral
Will eliminate looking for new official text in multiple places; needs of print customers to be considered
Official USP-NF Publications
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USP World Regions
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USP Global Sites
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New USP-India Site
Inauguration September 2, 2011
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China Expansion—Fall 2013
Building Today Architect’s Rendering
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Comment on proposed revisions through the online Pharmacopeial Forum
Participate in Expert Committees, Expert Panels– Calls for Candidates for Expert Panels ongoing– Call for Candidates for the 2015-2020 Council of Experts coming
Fall 2013
USP-sponsored Regional Laboratory Networks
Visiting Scientist Program
Global Fellowship Award Program
International Training Program
Science Meetings
Opportunities to Get Involved with USP
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Promotes the scientific exchange
Hosts scientists from other countries at USP to strengthen the alignment of the participants’ technical competence and experience with USP’s technical needs and objectives.
The program typically a three-month visit to USP’s headquarters in Rockville, Maryland or to one of USP’s international sites, where participants work hand-in-hand with USP scientific and technical staff on projects of mutual interest.
Participants are selected via a competitive nomination process.
Visiting Scientist Program
For more information, please contact Nilsa Esters at:
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Provides support to students whose research directly addresses specific USP scientific or research needs.
Awards three $50,000 Fellowships to students who have been accepted for full-time study in a Ph.D. or Pharm.D. program or medical or dental school, or have been awarded a postdoctoral research (non-faculty) appointment.
The program allows for subsequent yearly- funding for up to three years.
USP Research Fellows are selected through a review process to ensure the alignment of the proposed research with specific areas of USP research needs.
Fellows work closely with USP scientific and technical staff throughout the academic year and present their research results to USP standards-setting bodies.
Global Fellowship Awards Program
For more information, please contact Helen Kharab at:
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Promotes the exchange of scientific expertise between global organizations committed to the quality of medicines and foods.
Strengthens, expands, and enhances existing compendial and regulatory knowledge base.
Participants receive training with USP scientific and technical staff on compendial topics. Curriculum includes classroom study supplemented by laboratory learning.
International Training Program
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Two-week program at USP headquarters in the United States.
Priority is given to USP global collaborators established through agreements and activities as part of USP’s strategic efforts in regions and countries. Participation is open to national and regional OMCL’s, pharmacopoeias, and other government agencies.
For more information, please contact Linda Stelling at [email protected].
International Training Program
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