How to Write a Supplier Quality Agreement
Define, in writing, who is responsible for what quality activity between you and a supplier.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
A supplier (or quality) agreement is the written contract that defines the quality responsibilities between a company and its supplier, contract manufacturer, or contract laboratory — who does what, who decides what, and how quality issues are handled. For outsourced GxP activities it is not optional: regulators expect the responsibilities to be defined and agreed, not assumed.
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Define scope and the parties’ roles
Define the scope precisely — which materials, products, services and sites — and the role each party holds. A single agreement covering a supplier’s whole relationship usually covers the specific arrangement poorly, and scope stated by company rather than by site is the ambiguity that matters when the supplier manufactures in more than one place.
- 2
Assign specific quality responsibilities
Assign the specific quality responsibilities item by item rather than in general terms: who sets specifications, who tests and to what method, who releases, who investigates a deviation affecting the material, who approves changes, and who owns the regulatory position. The value of the document is entirely in this section, and generality here is the reason disputes happen.
- 3
Define change and deviation notification
Define change and deviation notification concretely: which changes require prior approval, which require notification, in what time, and to whom by name or role. A supplier obliged to notify significant changes will apply their own definition of significant, and it will differ from yours in exactly the cases you care about.
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Set audit and access rights
Set audit and access rights, including the right to audit at the site that performs the work, the notice required, and access for regulatory inspections. Where the supplier subcontracts, state whether those rights extend to the subcontractor, because a right that stops at the first tier stops short of where the work often is.
- 5
Address data integrity and records
Address data integrity and records explicitly: what records are generated, who retains them and for how long, in what form they will be provided, and the expectations for the systems that produce them. Certificates of analysis generated from systems you have no visibility of are assurances about an unexamined process.
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Review, sign, and keep it current
Review the agreement on a defined cycle and whenever the arrangement changes, with both parties signing. Agreements drift silently as products, sites and subcontractors change, and the most common finding is an agreement that is current in the file and obsolete in practice.
- !Responsibilities left ambiguous, so an activity falls between the two parties.
- !No requirement for the supplier to notify changes before implementation.
- !A quality agreement buried in the commercial contract with no quality-unit ownership.
- !Signed once and never updated as the relationship or products change.
How to Write a Supplier Quality Agreement: frequently asked questions
Common questions on write a supplier quality agreement.
Is a supplier quality agreement required?
For outsourced GxP activities, regulators expect the quality responsibilities between the parties to be defined and agreed in writing (EU GMP Chapter 7 for contract manufacture/analysis; FDA expectations for contract facilities). It is effectively required whenever GxP work is outsourced.
What is the difference between a quality agreement and a commercial contract?
The commercial contract covers price, volume, and business terms; the quality agreement covers quality responsibilities — release, testing, change control, deviations, audits, and data integrity. They should be separate (or clearly separable) so quality terms are owned by the quality unit, not buried in procurement.
Who owns the quality agreement?
The quality units of both parties own and approve it. Although procurement or legal may facilitate it, the substance is quality responsibility, so quality — not just commercial functions — must define and sign off on it.
What is the most important clause?
Clear delineation of responsibilities, especially around change notification. The most damaging supplier-quality failures come from an unnotified change to a material or process, so a binding requirement to notify (and gain approval for) changes before implementation is critical.