This document discusses quality agreements (QAGs) between clinical trial sponsors and vendors. It covers the basis and purpose of QAGs in clinical trials, considerations for the content of QAGs, and how to operationalize and use QAGs during regulatory inspections. Key points include that QAGs establish expectations between parties, important content areas cover quality control, auditing, and regulatory responsibilities, and QAGs can help demonstrate delegation of roles during inspections.

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exl Quality Oversight of
Clinical Vendors
Conference
Operationalizing the
Quality Agreement
Stan Szpindor, M.S.
Director, R&D Quality Operations

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Areas to be Covered
 Basis for a Quality Agreement (QAG) and use in the
GCP Setting
 Practical Considerations for Content
 Operationalizing the Quality Agreement
 Use During Inspections

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QAG Basis
THE QUESTION:
Is The Use Of A Quality
Agreement Suitable For The
GCP Environment?

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QAG Fundamentals
 Common Terms: Quality Agreement, Technical
Agreement, Master Quality Agreement
 Definition:
 Legal: An Expression of Assent by two or More Parties to
the Same Conditions
 QAG: An Arrangement Between Two or More Parties
Engaged in a Business Relationship Pertaining to the
Quality Responsibilities of Each
 Goal: To Establish Expectations
 Not One Sided

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QAG Fundamentals
 Background:
 U.S.: Expectations for use have developed from interpretation of
cGMP regulations
 21 CFR 211.22(a) pertains to the quality control unit and makes
reference to contracting out these tasks
 QAGs have been used in cGMP arena for many years
 EU: Required under Directives 2003/94/EC and 91/412/EEC
 EU GMP Guide further defines “contract giver” and “contract
acceptor”
 More commonly referred to as Technical Agreement

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Elements of the QAG
 Parties and Recitals
 Legal Entities being Bound by Agreement
 Type of Businesses and References to Master Service Agreement
 Interpretations
 Notes terms of QAG Intended to Supplement and not Conflict with MSA
 Prevailing Agreement
 Scope
 Overarching and Relationship Based
 May reference a specific Product
 Can be limited to only one or two Services

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Elements of the QAG
 Definitions
 Ensure Consistency and Common Ground
 Miscellaneous
 Term: separate or tied to MSA
 Confidentiality Reinforcement
 Key Contacts and Notices (QA, Legal)
 Conflict Resolution
 Content
 Content Goal: “Bridge the Gaps”
 Transparency and Cooperation
 Relationship Governance Board

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Content Considerations
cGMP
1. Product Specifications
2. Quality Control Testing
3. Complaint Handling
4. Record Keeping and Reports
5. Batch Production Controls
6. Process Validation
7. Equipment Cleaning
8. Change Control
9. In-process Testing
10. Deviations & Investigations
11. Product Recall
12. Shipping Process
13. Packaging & Labeling
14. Audits & Inspections
GCP
1. Quality & Quality Assurance
2. Standard Operating Procedures
3. Regulatory Inspections
4. Scientific Misconduct
5. Functional Plans
6. Investigational Product Complaints
7. Subject Confidentiality/HIPAA
8. Lessens Learned
9. Access to Original Source Documents
10. Use of Electronic Systems
11. Protocol Violations
12. Qualified Personnel
13. Subcontracting
14. Relationship Governance

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To be as brave as the people we help
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Content Considerations Cont.
Audit Conduct (Routine &
For-Cause) • Types of Audits: Site, Service Provider, TMF, Data, PV, CSV
• Notification Process / Lead Time
• Personnel: Sponsor, Independent, Competitor
Audit Report Facilitation &
Access • QA to QA Distribution of Audit Reports
• Cycle time to Secure CAPAs
• Time Extensions, Return for More Information
• Access to Provider Audit Reports for Project Specific and Process
Regulatory Inspections • Notification & Timeframe for Notice
• Rights for Preparation and Onsite Support
• Permissions for Making Commitments & Response Review
Scientific Misconduct • Notification, Investigation, Serious Breach Reporting, Site Closure
Electronic Systems • Expectations for SDLC, Validation, Part 11 Compliance, Documentation
• Investigator-based: Direct Access, Testing, Documentation

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To be as brave as the people we help
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Content Considerations Cont.
Subject Confidentiality
• Applicability of Regulation: HIPAA, EU Data Protection
• Safeguard of subject data to EU Directive 95/46 EC
Quality Control
• Process for Documented Review of Deliverables
• Current Procedures
• Access for Periodic Review
•Sponsor lead Functional Assessments
Archive • Storage Timeframes Onsite, Offsite, and Costs
• Fulfillment Times During Inspections
• Transfer to Sponsor
Qualified Personnel • Minimum Experience Requirements & CV/Job Description Req.
Protocol Violations • Expectations for Documenting, Reporting, Tracking
• Waiver Position

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Operationalizing the QAG
 When Will You Use?
 Strategic Partners, Global Providers, Niche Vendors
 Volume of Studies, $$ Spend, Importance of the Studies
 How: Standalone vs. Part of Service Agreement
 Standalone if Agreement Already in Place, Expected Delays
in Negotiating the Service Agreement, Legal Review a
Nightmare
 Appendix to Agreement if New Relationship, Will have
Greater Enforceability, More Difficult to Update

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Operationalizing the QAG Cont.
 What Format?
 Tabular: Ease of Review, Clear Delineation of Responsibility
 Legal Style: TOC, Intro., Recitals, Disclaimer Pages
 Hybrid
 How to Negotiate?
 Quality Agreement Does Not = QA Exclusivity
 Identify Internal Stakeholders  Empowered
 Ask the Domain Question
 Small Cross-Functional Team at Table or QA-to-QA

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Operationalizing the QAG Cont.
 Legal Review?
 Absolutely if Part of Overall Agreement
 Maybe Not if Standalone
 Legal Approval of Template with Highlighted Fields
 Items to be Left Out: Force Majeure, Payment Terms,
Arbitration, Terminations, Settlements
 Maintenance?
 Predetermined based on Set Date
 Periodic Review
 Transferable & Assumable

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Use During Inspections
 How Do You Demonstrate Delegation of Key Roles
and Responsibilities?
 MSA with Statement of Work?
 Delegation of Responsibilities Matrix?
 Quality Agreement
 Regulators Want to Know About Oversight and How
the Parties have Assigned Responsibility

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Defining the Business Relationship
 Ongoing Dialogue and Negotiation = Success
 Recommend Face-to-Face for Initial Iteration
 Stay Grounded in Reality
 Anticipate Problems and Acknowledge Upfront
 Plan for Resolution Before Occurrence
 Choose Wisely
 Best QAG Cannot Make up for Poor Business Decision
 If Study Doesn’t Match the Provider’s Capabilities, Project
Will Fail and All Parties Will Suffer

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QUESTIONS