Contenu connexe Similaire à Ron Piervincenzi: "USP Standards: Facilitating a fair and competitive marketplace and advancing public health" (20) Plus de The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics (20) Ron Piervincenzi: "USP Standards: Facilitating a fair and competitive marketplace and advancing public health"2. USP Standards
Ronald T. Piervincenzi, Ph.D.
Chief Executive Officer, USP
October 24, 2018
Facilitating a fair and
competitive marketplace
and advancing public health
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Standards help promote market entry
Reduce risk to new market
entry
Build quality environment
for medicines
Increase competition
Competition in
marketplace
Quality medicines
& advanced drug
manufacturing
systems
Lowers floor on
quality & leads to
substandard
products
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USP overview
Standards and quality
Research and innovation
Promoting access
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7. Need for standards
11 Founding members
with a vision
Legal recognition
Official compendium
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8. ”
Today: Our mission
To improve global
health through public
standards and related
programs that help
ensure the quality,
safety, and benefit of
medicines and foods.
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9. We work globally
USP site
USP site with
laboratory
USP-US
Rockville, MD
Frederick, MD
Washington, DC
USP-BRAZIL
Sao Paulo
USP-GHANA
Accra
USP-NIGERIA
Lagos
USP-
SWITZERLAND
Basel
USP-ETHIOPIA
Addis Ababa
USP-INDIA
Hyderabad
USP-CHINA
Shanghai
USP-INDONESIA
Jakarta
USP-SINGAPORE
Singapore
USP-PAKISTAN
Islamabad
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11. Partners in
industry
R&D companies and
generic
manufacturers
Partners in science
With academics,
practitioners
Partners in
government
With regulatory and
health authorities
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Partnerships at the heart of quality
12. USP staff and volunteer experts partner to
develop standards
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14. Overview
What is a standard?
How do standards reduce
risk to manufacturer
market entry?
15. Standards reducing risk at market entry
USP Standards
– Limit risk for manufacturers by
providing for regulatory (e.g. FDA)
compliance by equipping
manufacturer with:
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Quality
API
Quality
process
Promoting
quality
medicine
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Quality is at each step of USP standards development
Pharmaceuticals Food ingredients Healthcare quality
Dietary supplements
and herbal medicines
Global public health
Suppliers
Manufacturers
Wholesale/
Distributors
Pharmacies/
Hospitals
Healthcare
Patients
Public view
Supply
chain view
19. Documentary standards
Monographs
– Name of substance and definition
– Analytical procedures and criteria needed
to ensure strength, quality and purity of
drug
General chapters
– Broadly applicable procedures and
methods
– Water content, residue on ignition, etc.
General notices
– Interpretation and application of standards,
tests and other specifications of the USP-
NF
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20. Reference standards
Characterized physical specimens used
in tandem with USP monographs to
demonstrate identity, strength, quality,
and purity of a product
Active pharmaceutical ingredient (API)
– Testing of raw material (drug ingredient)
Excipient
– Component of finished drug product other than
API added during formulation for a specific
purpose like stabilizing an API
Impurities
– Controlling of related organization impurities in
drug product and API
– USP helps identify and test impurities to promote
quality
Build confidence in quality active
ingredients and excipients for drug
entry to marketplace
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Developing standards
Parallel tracks to create integrated
documentary and physical
standards for simultaneous use
22. Standards reducing risk at market entry
Facilitates manufacturer entry to
marketplace with benchmark for quality
Ensure the quality of products across
all monographs
– Example: Dissolution testing ensures
uniform active ingredient in entire batch
– Identification of impurities
Speed to manufacturer entry is faster
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25. USP Research to advance quality standards
Up to date
Quality institute
Emerging technologies
26. Up to date: Ongoing revisions
Updating quality standards:
– Revising standards to reflect “state of
the industry” practices
Identify gaps:
– Ensuring components are clear,
complete and correct
– Removing unnecessary tests
– Providing appropriate selection of
reference standards
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27. USP Quality Institute research
Aims to generate a rigorous evidence
base to advance medicines quality by :
– Informing discussions among
stakeholders
– Informing public policy & regulatory
reforms
– Providing rationale for investments in
quality medicines
– Partnering with leading academic
institutions on research fellowships
• Current research: How poor-quality
medicines contribute to AMR
• Next up: Research on excipients quality
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28. Emerging technology
Exploring emerging technologies
Defining quality in new paradigms
Examples:
– Pharmaceutical continuous
manufacturing
– qNMR and digital reference standards
– 3-D printing
– Next generation biologics and cell/gene
therapy
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30. Public standards support manufacturer
entry to marketplace
Building capabilities across the globe
because manufacturing system is
global
USP promotes quality medication access
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Building capabilities across the globe
USP Education-
Hyderabad
Training Institute
USP APEC Center
of Excellence
USP Advocacy-
Opioid Roundtable
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USP-Global Public Health
Access to quality medicines to protect patients and improve outcomes
34+ countries supported to strengthen health systems through improved quality assurance and
regulatory systems
28+ manufacturers supported to receive SRA approval or WHO pre-qualification
4,000+ regulatory and manufacturing professionals trained
Strengthening regulatory systems to
ensure access to quality medicines
Providing technical assistance for:
Dossier evaluation
Market authorization
Inspections
Post-marketing surveillance
Testing and quality control of medical products
Supporting manufacturers to increase
the supply of quality medicines
Provide end-to-end support to
manufacturers to:
Implement strong quality systems
Identify and address corrective actions
File dossiers for product approval
Prepare for inspections
33. Coalition of regulators, non-
governmental organization, academics
and other key stakeholder groups
Sharing evidence, generating human
stories
Call to Action
World wide advocacy
#MedsWeCanTrust campaign
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34. Facilitate a fair and
competitive marketplace
Advance public health
Reduce risk to manufacturer
entry to drug marketplace
USP standards:
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