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

USP Web Resources

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13

Calendar

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Key Issues

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Free Resources

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

Spirit of Voluntarism

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

Question & Answer Session