To be as brave as the people we help

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exl Quality Oversight ofClinical 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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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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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