promotional materials and q litd a quality management ... 6 - o'brien - pearl... ·...
TRANSCRIPT
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
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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
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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”
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What is a Quality Management System?
• QMS is a:– systematic, organizational structure needed to ensure a
“product” [e.g., PMs] meets expectations.
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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)
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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
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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.
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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
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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
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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
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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?
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Control Strategy –Example for Production of PMp
Development and Approval Production Dissemination Discontinuation
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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
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Shameless Advertisement…
• Poster Presentation on same topic….Poster Presentation on same topic….– Abstract #44796
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