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Promotional Materials d Q litand a Quality

ManagementManagement System Approach

Katie O’BrienAssociate Senior Consultant –Global Quality SystemsEli Lilly and Company

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2www.diahome.orgDrug Information Association

Objectives:

• Introduce Quality Management System (QMS)Introduce Quality Management System (QMS)• QMS: one approach for promotional materials (PMs)• Lifecycle of PMsLifecycle of PMs

Drug Information Association www.diahome.org 3

Background: QMS

• Other references:ICH Q10: Pharmaceutical Quality System– ICH Q10: Pharmaceutical Quality System

– ICH Q8: Pharmaceutical Development (QbD)ICH Q9 Q lit Ri k M t (QRM)– ICH Q9: Quality Risk Management (QRM)

– http://www.ich.org/products/guidelines/quality/article/quality guidelines htmlarticle/quality-guidelines.html

• Adopted in manufacturing as the way to hi lit / l t t tiachieve quality/regulatory expectations


Why try a QMS approach with PMs?

• Facilitates Voluntary Compliance:“Obj ti i t h li t ti d t“Objective is to have compliant promotion and not

have violative promotion in the marketplace. Violative promotion needs to be addressed byViolative promotion needs to be addressed by enforcement actions”

• Tom Abrams- FDA, OPDPo b a s , O(2010 DIA conference)

• FDA and other regulatory authorities “foster g ysuch approaches” [QbD and QRM]

• Leslie Ball, M.D and Ann Meeker-O’Connell – FDA“Building Q into Clinical Trials- A Regulatory Perspective”


What is a Quality Management System?

• QMS is a:– systematic, organizational structure needed to ensure a

“product” [e.g., PMs] meets expectations.


Diagram by Karn G. Bulsuk (http://www.bulsuk.com)

QMS offers a way to enable:

• compliant PM in the marketplace p p(Compliance)

• a process that is monitored anda process that is monitored and institutionalized (Sustainable)

• the ability to respond to changing• the ability to respond to changing expectations (Continuous Improvement)


ICH Q10: Pharmaceutical Quality System

Lifecycle of Drug Product per ICH Q10

Pharmaceutical Development

Technology Transfer

Commercial Manufacturing

Product Discontinuation

Lifecycle of Drug Product per ICH Q10

Lifecycle of Promotional Material (PM)Development and Approval Production Dissemination Discontinuation


The Quality Management System- Defined

Quality Management System is a combination of 4 elements (

Requirements Procedures(requirements, procedures, peopleand management responsibility), which assure that the output meets the defined quality objectives in a manner

PeopleManagement Responsibility

defined quality objectives in a manner that is based on good science and appropriate risk management, drives continuous improvement, and meets

l t i t dregulatory requirements and company values.

9

Quality System Approach – Sports Theme

Q Objective: To win the gameTo play safelyTo play fair

WhatR l f th G

How•The Team Play Book•Rules of the Game

•Tournament Regulations

y•Position on team = role/responsibility

Management Responsibility Who

hp y

•Team Owners•Team Coaches•Referees•League Officials•Game Reviews

•Team Coaches•Players on the team

•Game Reviews •Rules Reviewed

10

Quality System Approach – PM

Q Objectives: To create accurate, truthful and non-misleading materialTo produce what was actually approvedTo disseminate at the right time to the right audience

What How

To disseminate at the right time, to the right audience

What•Federal Regulations•OUS Regulations•Learned Lessons•Internal Business Expectations

•Designed to meet the “What”•Job Specific Processes •Procedures

Social Media

Management Responsibilities

•Escalation process defined

Who•Capable and trained

Marketing Medical•Metrics

•Audit

MedicalRegulatoryLegal

11

QMS – Lifecycle of PM

Development d A l Production Dissemination Discontinuation

and Approval Production Dissemination

Q H d th i ti h t i th lif l d i d?Q: How does the organization ensure each step in the lifecycle occurs as designed?

A: Design a robust Control Strategy

Q: What is a Control Strategy?

A: Specific measures identified and implemented to manage risk and reduce errors

•Science Based Decisions•Risk Based Decisions


ICH Q9: Quality Risk Management (QRM)

• What might go wrong?ld b ?

Risk

Assessment

• How severe would it be?• How likely is it to happen?

Risk Control

• What checks and verifications are needed?• What should be documented?• Who should conduct certain steps?

• Monitor the performance and trends?

Risk Review

p• Are the controls working?• Are the risks changing?


Control Strategy –Example for Production of PMp

Development and Approval Production Dissemination Discontinuation


QMS: What’s next?

Development and Approval Production Dissemination Discontinuation and Approval

Four Elements of the QMS:Req irements•Requirements

•Procedures•People•Management responsibility g p y

Must Implement Core Quality System Elements: P t it f d lit•Process to monitor performance and quality

•Process to detect errors and implement fixes •Process for management review


Shameless Advertisement…

• Poster Presentation on same topic….Poster Presentation on same topic….– Abstract #44796


Acknowledgements

Co-authorsCo authors– David Fryrear, Advisor Global Quality Systems

Tim Grey Consultant Global Quality Systems– Tim Grey, Consultant Global Quality Systems


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