Post on 14-Jul-2018
USP Programs & Resources Christine Hiemer Senior National Account Manager U.S. Pharmacopeial Convention
Voluntary programs for
– Dietary supplement ingredients
– Dietary supplement finished products
– Pharmaceutical ingredients – APIs and excipients
Audit, document review, ingredient testing
USP Verified Mark—symbolizes that the item meets USP requirements
USP Verification: Quality Assured
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
Review the manufacturer’s 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
USP Verification Includes
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
USP Global Education and Training
Classroom: USP offers face-to-face sessions in traditional classroom settings around the world. Engage with experts and peers and get immediate answers to questions. Classroom courses can be customized to your specific needs and delivered at your company location.
Laboratory: USP laboratory sessions provide hands-on training in a working laboratory facility. Many courses combine a classroom lecture with a laboratory segment to ensure that you gain comprehensive and practical knowledge of USP standards and how to apply them effectively in your work.
Online: USP online courses are designed with flexibility and easy access in mind. Through the Internet from anywhere in the world, you can view interactive presentations, listen to live and/or recorded lectures, and contact USP experts. We offer three types of online courses: Live; On-Demand; Self-Paced eLearning
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Convenient Format Options
<1084> Glycoprotein Glycan Analysis
Bioassay Validation <1032>, <1033>,
and <1034>
Essentials of Microbiological Testing
Rapid Microbiological Testing
Standards for Food Ingredients and
Dietary Supplements
Analysis of Elemental Impurities
<1079> Updates on Good Storage and
Shipping Practices
Dissolution: Theory and Best Practices
Global Education and Training Courses
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USP Global Education and Training Catalog
<1083> Good Distribution Practices:
Supply Chain Integrity
General Chapters <1224>, <1225>,
and <1226>—How They Work
Together for Analytical Procedures
How to Use the Online
Pharmacopeial Forum (PF)
Impurities in Drug Substances and
Drug Products—A USP Approach
Method Transfer
Pharmaceutical Waters
Classroom On-demand
Location designated by company
Opportunity to put course content within
the context of your organization
Contact Account Management
Team or send an email to
PharmEd@usp.org
On-Site Delivery
USP 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
– Adulteration of Food & Dietary Supplements – September 26–27, 2013
– Ophthalmic Preparations – October 20–21, 2013
– Cell and Tissue-based Regenerative Medicine Products: From Characterization to Compendial Assays – November 7– 8, 2013
– Extractables - Leachables Workshop – December 9–10, 2013
– Nanomaterial Drug Products: Current Experience and Management of Potential Risks – January 14–15, 2014
USP Workshops
USP Workshops
Enable an exchange of information and perspectives between USP and
users of USP standards, with the ultimate goal of improving the standards
Topics include specific USP proposals and other compendial activities
– Agenda topics can also be proposed via email by stakeholders
Web-based option for remote attendance
For more information and registration go to:
USP Stakeholder Forums
USP Stakeholder Forums
US Stakeholder Forum Stakeholders Frequency
Prescription/Nonprescription
Drugs
Prescription and nonprescription drugs,
excipients, associated service providers
Annual
June 27, 2013
Veterinary Drugs Veterinary drugs, associated service
providers
Annual
November 20 – 21, 2013
Dietary Supplements Dietary Supplements, traditional
medicines, associated service providers Next meeting: TBD
Food Ingredients Foods, food ingredients, associated
service providers Next meeting: TBD
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
USP Symposia
Science & Standards Symposium
Compendial Tools
Compendial Tools
Compendial Tools are documents, spreadsheets, databases, photographs, and other
items that are intended to aid the user in the application of USP standards. These tools
are not official, and do not affect the interpretation of the USP, NF, FCC, or any other
USP-developed compendium. These tools are not intended to be used to determine
that an article does or does not comply with compendial requirements, are not sufficient
for that purpose, and should not be used in that manner. These tools are used at the
user's own discretion and risk.
The following Compendial Tools currently are available:
•Calculation Tool for the Performance Verification Test (PVT) of Dissolution Assemblies
•Dissolution Toolkit
•Uniformity of Dosage Units (General Chapter<905>) Calculator
•Column Equivalency
•USP Four Parameter Logistic (4PL) Bioassay Simulator
USP Reference Standards
Catalog
– www.uspcatalog.com
USP Interactive Resources
24/7 order access
Updated every 24 hours
Order tracking and
order history
Ability to personalize your ordering
and shipping requirements
Order confirmation
All products (except
controlled substances)
USP Store
USP Store
USP–NF
– Submission of monographs, revision proposals
– Comment through PF
– Better understanding and use through Global Education and Training
– Council of Experts
– Opportunity to impact public standards
Reference Standards
– Bulk donation
– Participation in collaborative testing
Become an USP Expert Volunteer
Your Involvement with USP