State of the Art Instrumentation In Standard Setting - usp.org · High-Tech “State of the Art Instrumentation” does not improve patient safety •Unless there is a SPECIFIC safety

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

USP Prescription - Nonprescription Stakeholders Forum

3

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



From USP Web Site

• USP Seeks Submission of Proposals for

Monograph Modernization

• We seek Industry Collaborators to assist in this

effort



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



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

State of the Art vs. Modernization


Modernization vs the World


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


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


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.


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


State of the Art vs. Product Quality


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


Product Quality - Quality By Design

• Same Material

• Same Quality

• Multi-compendial testing

• USP-NF, PhEur, JP

• Different Results?


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


• 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


Harmonization and Modernization




• 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



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


Industry Supports

• Analytical testing

that Addresses a

Specific Health and

Safety Need

• And Ensures Patient

Safety

USP Prescription - Nonprescription Stakeholders Forum

25

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


Company Confidential © 2015 Eli Lilly and Company

Thank You!

27

Documents

State of the Art Instrumentation In Standard Setting - usp.org · High-Tech “State of the Art Instrumentation” does not improve patient safety •Unless there is a SPECIFIC safety