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USP Resources and Programs. USP Publications USP–NFUSP–NF Formats Hardcover Print Published Annually Facilitates tracking of revisions and additions.

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Presentation on theme: "USP Resources and Programs. USP Publications USP–NFUSP–NF Formats Hardcover Print Published Annually Facilitates tracking of revisions and additions."— Presentation transcript:

1 USP Resources and Programs

2 USP Publications

3 USP–NFUSP–NF Formats Hardcover Print Published Annually Facilitates tracking of revisions and additions Thumb tabs for easy access to sections Electronic Online (internet-based) NEW! - Single User USB Flash DriveFlash Drive –Available for purchase with USP 35–NF 30

4 USP 35–NF 30 The USP 35–NF 30 contains 20 new Monographs, 6 new General Chapters, 53 revised Monographs, and 11 revised General Chapters USP 35–NF 30 Main Edition –Publication Date: November 1, 2011 –Official Date: May 1, 2012 USP 35–NF 30 First Supplement –Publication Date: February 1, 2012 –Official Date: August 1, 2012 USP 35–NF 30 Second Supplement –Publication Date: June 1, 2012 –Official Date: December 1, 2012

5 USP Dictionary of USAN & International Drug Names FDA-recognized source for established drug names in the U.S. and around the world Includes –U.S. Adopted Names (USANs), International Non-proprietary Names (INNs), Brand Names and manufacturers, BANs, JANs –Unique Ingredient Identifier (UNII) codes established by the FDA/USP Substance Registration System for substance tracking Chemical names and structures, formula weights, pharmacologic and therapeutic categories Published annually in April Print and online formats

6 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 every two years, with two annual Supplements between editions Print and online formats, English only Updated via the free online FCC Forum, open twice a year for 90-day comment periods

7 USP Dietary Supplements Compendium Combines USP–NF dietary supplement standards with information from the FCC, regulatory documents, and other industry resources. Approximately 400 USP–NF monographs for dietary supplement manufacturing More than 150 FCC monographs Approximately 150 NF excipient monographs Step-by-step tests, assays, and procedures Full color illustrations Reference tables, charts, and federal and regulatory guidance from FDA, industry, and more 2012 DSC is currently for sale (Two Volume Set) –64 new monographs –Excipients section –More illustrations (Over 230 pages )

8 Chromatographic Columns Now a Free online-only resource! Provides brand names of columns used in validating all proposed and official gas- and liquid-chromatographic procedures in PF and USP–NF Includes an index of manufacturers Increases accuracy and consistency of results in official tests and assays Go to to access this resource (a one time registration is required)www.uspchromcolumns.com

9 Pharmacopeial Forum (PF) The PF is the bimonthly online journal through which USP develops and revises standards for the USP–NF by a process of public review and comment. The PF includes the following: –Standards Development –How to Use PF –In–Process Revision –Proposed Interim Revision Announcements (IRAs) –PDG Harmonization Proposals (Stage 4) –Stimuli Articles Go to to access the PF (a one time registration is required)www.usppf.com

10 Pharmacopeial Forum The following items that were formerly located in the PF print subscription have been relocated to appropriate locations on the USP website: –Policies and Announcements –Final IRAs –IRA Reference Standard Information –Errata –Previous PF Proposals Still Pending –Canceled Proposals –PDG Harmonization Process and Harmonized Standards (Stage 6) Links to these items will be maintained on USP website at

11 USP Verification: Quality Assured Voluntary programs for –Dietary supplement ingredients –Dietary supplement finished products –Pharmaceutical ingredients – APIs and excipients Audit, document review, ingredient testing USP Verified Marksymbolizes that the item meets USP requirements

12 USP Verification Includes Audit the manufacturing site Review chemistry, manufacturing, and controls (CMC) documentation Test samples for compliance with USP–NF monograph or, if no monograph exists, the manufacturers own analytical procedures Review the manufacturers post-verification/ qualification notification of changes Re-test items periodically after they first pass the initial verification/qualification lab testing Award USP Verified Mark to ingredients that pass Re-evaluate each article at least every third year

13 Pharmacopeial Education USP Teaching USP–NF and FCC Teaching efficient use of USP standards Providing the tools to maintain compliance with USP–NF and FCC public standards Ideal opportunity to discuss compendial issues with knowledgeable USP staff

14 Current Face-to-Face PE Offerings Analysis of Elemental Impurities Validation and Verification of Analytical Procedures Dissolution Testing: Theories and Best Practices (2-day course) Developing and Validating Dissolution Methods In-Vivo In-Vitro Correlation (IVIVC) Impurities in Drug Substances and Drug Products – A USP Approach Understanding USP Requirements on Weights and Balances USP Perspectives on Pharmaceutical Waters Essentials of USP Microbiological Testing Effectively Using the USP–NF Effectively Using the USP–NF Bioassay Validation, and Effectively Using Reference Standards Determining Particulate Matter in Parenterals Method Transfer For a complete listing of courses, please visit courses/courseshttp://www.usp.org/meetings- courses/courses

15 Webinars USP is now offering frequent webinars on various topics Live Webinars: –For an up-to-date listing, visit courses/courseshttp://www.usp.org/meetings- courses/courses On Demand Webinars: –New Proposed Spectroscopy Chapters –Elemental Impurities Overview –,, How they work together –For a complete listing, please visit courses/courseshttp://www.usp.org/meetings- courses/courses On Demand Tutorials –How to Access USP–NF Information Online –How to Communicate Feedback to the USP –How to Use the PF Online –For a complete listing, please visit courses/courseshttp://www.usp.org/meetings- courses/courses –Sign up for the Pharmacopeial Education Bulletin for updatesPharmacopeial Education Bulletin

16 On-Site Delivery Location designated by company Opportunity to put course content within the context of your organization Contact Account Management Team or send an to

17 USP Workshops USP web forums and workshops encourage discussion of a wide range of current scientific findings and regulatory trends. Participants discuss hot topics that concern the public and exchange practical advice. Upcoming Workshops –Microbiological Control of Compendial Articles – March 18–19, 2013 –Pharmaceutical Packaging: Moisture Permeation and Integrity Testing – May 20, 2013 –Extractables-Leachables Workshop December 9–10, 2013

18 Open to the public, the symposia serve as interactive forums where stakeholders representing industry, government, and academia can obtain industry benchmark information, network with thought leaders, and contribute early in USPs standard-setting process through discussions with USP staff, members, and volunteers. Baltimore, Maryland, USA September 17–19, 2013 San Antonio, Texas, USA September 23–25, Science & Standards Symposium

19 USP Web Resources

20 Monthly notices...

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22 Where to find… USP Contact List USP Meetings USP Courses USP Calendar of Events Pending Standards USP Compendial Notices USP and PF Publication PF Information Monthly Notice process/publication-comment-schedule

23 Reference Standard Information RS Catalog and technical Data Sheets –http://www.usp.org/reference-standardshttp://www.usp.org/reference-standards New RS Notification –http://www.usp.org/reference-standards/find-reference- standard/notification-servicehttp://www.usp.org/reference-standards/find-reference- standard/notification-service RSs FAQs –http://www.usp.org/support-home/frequently-asked-questions/reference- standardshttp://www.usp.org/support-home/frequently-asked-questions/reference- standards Suggest New RS –http://www.usp.org/reference-standards/find-reference-standard/suggest- reference-standardhttp://www.usp.org/reference-standards/find-reference-standard/suggest- reference-standard RS Use & Storage –http://www.usp.org/reference-standards/use-and-storagehttp://www.usp.org/reference-standards/use-and-storage RS Technical Support Reference Standards Under Development –http://www.usp.org/reference-standards/find-reference-standard/reference- standards-under-developmenthttp://www.usp.org/reference-standards/find-reference-standard/reference- standards-under-development

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