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PLANREFERENCE OUTLINE
Supplier Quality Agreement
Written quality agreement defining the GMP responsibility split between manufacturer and supplier/contract facility — responsibility matrix, notification duties, and audit rights.
REGULATIONS MAPPED
EU GMP Chapter 7ICH Q10
DOCUMENT TYPE
PlanLAST UPDATED
January 2025PURPOSE
A quality agreement that defines, in writing, the GMP responsibilities split between a manufacturer and its supplier or contract facility — who does what, who decides, and who is notified.
What's Inside
✓Scope and parties
✓Responsibility matrix (GMP activities)
✓Change and deviation notification obligations
✓Audit and inspection rights
✓Complaint, recall, and record-retention terms
How to Use It
1Define the products and services in scope
2Assign each GMP responsibility to a named party
3Set notification triggers and timelines
4Agree audit rights and inspection support
5Review and re-approve on a defined cycle
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose, Scope, and Parties
2Definitions
3GMP Responsibility Matrix
4Change and Deviation Notification
5Audit and Inspection Rights
6Complaints, Recalls, and Returns
7Records, Retention, and Confidentiality
8Term, Review, and Signatures
REGULATORY CONTEXT
EU GMP Chapter 7 requires a written contract defining outsourced GMP responsibilities, and ICH Q10 extends this to the supply chain. This template captures the responsibility split and notification duties.