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.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
EU GMP Chapter 7ICH Q10
DOCUMENT TYPE
Plan
LAST UPDATED
January 2025
PURPOSE

A written agreement defining how GMP responsibilities divide between a manufacturer and its supplier or contract facility — who performs each activity, who decides, and who must be told what, within what time. The clause that matters most in practice is notification: an agreement that assigns every activity but leaves change notification vague will fail at the first unannounced supplier change.

What's Inside

✓Purpose, scope, and parties, with the products, materials, or services covered stated specifically
✓Definitions, so terms such as critical change and significant deviation mean the same thing to both parties
✓GMP responsibility matrix assigning each activity to a named party, with joint responsibilities avoided or defined
✓Change and deviation notification obligations with triggers, timelines, and the route by which notice is given
✓Audit and inspection rights, including access, frequency, for-cause audits, and support during regulatory inspection
✓Complaints, recalls, returns, and the obligations of each party in a market action
✓Records, retention periods, confidentiality, term, review cycle, and signatures

How to Use It

1Define scope by product and service rather than by supplier, so a second material from the same supplier is not assumed covered
2Define the critical terms in the agreement itself; a notification trigger is only as good as the definition behind it
3Assign every activity to one party, and where responsibility is genuinely shared, state what each side does
4Set notification triggers and timelines explicitly, including planned changes, deviations affecting supplied material, and regulatory actions
5Agree audit rights including for-cause access, and state what support is owed during a regulatory inspection
6Review on a defined cycle and after any change of scope, and re-approve rather than letting the agreement drift
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 between contract giver and contract acceptor defining the GMP responsibilities of each party for outsourced activities, and requires the contract giver to assess the acceptor's suitability. ICH Q10 extends the expectation of managed outsourced activities and purchased materials across the product lifecycle, with responsibilities defined in advance. The responsibility split for your arrangement is a commercial and quality negotiation between the parties; this template structures it and does not decide it.

MAPPED STANDARDS
EU GMP Chapter 7ICH Q10
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