Transcript USP Resources and Programs

USP Resources and Programs
USP Publications
USP–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 Drive
– Available for purchase with USP 35–NF 30
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
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
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
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
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More than 150 FCC monographs
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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 )
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 www.uspchromcolumns.com
to access this resource (a one time
registration is required)
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 www.usppf.com to access the PF
(a one time registration is required)
Pharmacopeial Forum
 The
following items that were formerly located in the PF print
subscription have been relocated to appropriate locations on the
USP website:
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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
http://www.usp.org/USPNF/pf/
USP Verification: Quality Assured
 Voluntary
programs for
– Dietary supplement ingredients
– Dietary supplement finished products
– Pharmaceutical ingredients –
APIs and excipients
 Audit,
 USP
document review, ingredient testing
Verified Mark—symbolizes that the item meets
USP requirements
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 manufacturer’s own analytical
procedures
the manufacturer’s post-verification/
qualification notification of changes
 Review
 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
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
Current Face-to-Face PE Offerings
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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

Bioassay Validation <1032>, <1033> and <1034>
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Effectively Using Reference Standards

Determining Particulate Matter in Parenterals

Method Transfer
For a complete listing of courses, please visit http://www.usp.org/meetingscourses/courses
Webinars
USP is now offering frequent webinars on various topics
Live Webinars:
– For an up-to-date listing, visit http://www.usp.org/meetingscourses/courses
On Demand Webinars:
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 On
New Proposed Spectroscopy Chapters
Elemental Impurities Overview
<1224>, <1225>, <1226> How they work together
For a complete listing, please visit http://www.usp.org/meetingscourses/courses
Demand Tutorials
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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 http://www.usp.org/meetingscourses/courses
– Sign up for the Pharmacopeial Education Bulletin for updates
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 email to
[email protected]
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
http://www.usp.org/meetings-courses/workshops

Science & Standards Symposium
 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 USP’s 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, 2014
 http://www.usp.org/meetings-courses/symposia
USP Web Resources
Monthly Email notices . . .
Monthly Email notices . . .
Where to find…
USP Contact List
USP Meetings
USP Courses
USP Calendar of Events
http://www.usp.org/contact-us
http://www.usp.org/meetings-courses
http://www.usp.org/usp-nf/pending-monographs
Pending Standards
USP Compendial Notices http://www.usp.org/usp-nf/notices
USP and PF Publication http://www.usp.org/usp-nf/developmentprocess/publication-comment-schedule
PF Information
Monthly Email Notice
http://www.usp.org/usp-nf/pharmacopeial-forum
http://www.usp.org/store/free-resources/email-notice
Reference Standard Information
 RS
Catalog and technical Data Sheets
– http://www.usp.org/reference-standards
 New
RS Notification
– http://www.usp.org/reference-standards/find-referencestandard/notification-service
 RSs
FAQs
– http://www.usp.org/support-home/frequently-asked-questions/referencestandards
 Suggest
New RS
– http://www.usp.org/reference-standards/find-reference-standard/suggestreference-standard
 RS
Use & Storage
– http://www.usp.org/reference-standards/use-and-storage
 RS
Technical Support
– [email protected]
Reference Standards Under Development
– http://www.usp.org/reference-standards/find-reference-standard/referencestandards-under-development