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Company Confidential © 2015 Eli Lilly and Company
State of the Art Instrumentation In
Standard Setting
Douglas G. Muse
Global Quality Laboratories
Compendial Affairs
Eli Lilly and Company
Compendial Monographs
USP Prescription - Nonprescription Stakeholders Forum 2
State of the Art
Vs. Modernization
• From the USP web site:(EM1 Expert Committee)
• Priority Monograph Modernization Initiative
• Identify gaps in current excipient monograph
specifications
• to assure fit for purpose in a Global Supply Chain
setting
USP – Efforts to Modernize
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From USP Web Site
• Modernization and Priority Monograph lists
• Chemical Medicines Monographs Modernization
List
• Excipient Monograph Modernization List
• USP to ensure the methods in the USP-NF reflect
those that Industry Currently uses
USP – Efforts to Modernize
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From USP Web Site
• USP Seeks Submission of Proposals for
Monograph Modernization
• We seek Industry Collaborators to assist in this
effort
USP – Efforts to Modernize
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From USP Web Site
• USP intends to modernize these monographs
via traditional submission, or IF a submission is
not received…
• sent to USP’s Internal Laboratory for
development
USP – Efforts to Modernize
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From USP Web Site
USP – Research and Innovation
• USP conducts early stage evaluations of New
and Emerging Technologies
• “State of the Art Instrumentation”
• Analytical Technologies that may enhance
compendial testing performance
• Applications that can be integrated through the
USP standard setting processes
USP Prescription - Nonprescription Stakeholders Forum 7 From USP Web Site
Modernization vs the World
• USP is a Global organization recognized by 140 countries around the World
• Pharmaceutical Industry
• Supply Chain Globalization
• Excipients Manufacturing
• Drug Substance (API) Manufacturing
• Finished Drug Products Distribution
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Impact: State of the Art Instruments
• State of the Art Instruments are not always
available Globally
• Instrument
• Availability and Service
• Instrument Requirements, Infrastructure
• Chemists – Technicians, Training
• Reagents – Suppliers differ by country
• Columns – Single Sourced
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Impact: State of the Art Instruments
• Expensive instrumentation can not be Justified
for Infrequent Testing
• Testing requires Out-Sourcing to Third Party
Laboratories
• Out-Sourcing Requirements
• Time, Effort, Resources
• Added cost to testing USP Prescription - Nonprescription Stakeholders Forum 12
Many Global Stakeholders
• All Laboratories using the USP-NF are not Equal
• Excipient Manufactures
• Drug Product Manufactures
• Large and Small Companies
• Third Party Laboratories
• USP to ensure the methods in the USP-NF reflect
those that industry currently uses.
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Large
Small
Third Party
Excipient
Many Global Stakeholders
• All Quality Control Laboratories are not equal
• Advanced Analytical Instrumentation
• ICP-Mass Spectroscopy
• Quantitative NMR
• DNA Identification
• Belongs in a Research Laboratory, Not QC
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Product Quality - Quality By Design
• The Quality of compendial
grade materials is determined
by QbD, and Process
Controls
• State of the Art Instrument
methods do not improve
Product Quality
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Product Quality - Quality By Design
• Same Material
• Same Quality
• Multi-compendial testing
• USP-NF, PhEur, JP
• Different Results?
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Product Quality – Quality First
• What can we do
to ensure patient
safety?
Company Confidential © 2015 Eli Lilly and Company 18
• Start with the patient in mind!
• What specifications ensure the patient safety?
• What Instrumentation is necessary to ensure the
Accuracy and Precision provide Control against the
Established Specifications.
Product Quality - Quality First
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• Tighter limits should not be applied in one region
unless there is a Significant Justification
• Determining trace levels of impurities using
High-Tech “State of the Art Instrumentation”
does not improve patient safety
• Unless there is a SPECIFIC safety risk
Product Quality – Quality First
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Harmonization and Modernization
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• Harmonization
And
• Modernization
• Leverage current Harmonization activities to
supplement Modernization efforts.
• Pharmacopoeial Discussion Group, (PDG)
• Bi-Lateral Harmonization
• ICH
• State of the Art Instrumentation creates
Divergent Global Public Standards
Harmonization and Modernization
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Industry Supports
• Develop a scientific risk based approach that
ensures Public Safety
• Utilizing State of the Industry Instrumentation
• Monographs and General Chapters that improve
public health by reducing potential risks
• While Supporting the Global Supply Chain
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Industry Supports
• Analytical testing
that Addresses a
Specific Health and
Safety Need
• And Ensures Patient
Safety
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Acknowledgements
• Phyllis Walsh, Merck
• Priscilla Zawislak, Dow
• Dave Schonecker, Colorcon
• George Collins, Vanderbilt Chemicals
• David Klug, Sanofi
• Kathy Ulman, KLU Consulting
• Danita Broyles, Merck
• Anne Cook, Lilly
• Erin Wang, Lilly
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