Quality Agreement vs SLA
Who owns which quality decision vs who delivers what service level.
What a comparison is not
A comparison is SPEQ’s reading of how two published documents differ. Neither is the right answer, it is not a determination of which applies to you, and neither is summarised in a way that replaces reading it.
A quality agreement defines the GxP quality responsibilities between a company and a supplier or contract facility — who owns release, change control, deviations, and the like. A service level agreement (SLA) defines the operational performance expected — turnaround times, availability, response times. They answer different questions and should not be conflated.
| ASPECT | QUALITY AGREEMENT | SLA |
|---|---|---|
| Governs | Quality responsibilities and decision ownership | Service performance and metrics |
| Typical contents | Batch release, testing, change/deviation notification, audit rights | Turnaround times, uptime, response SLAs, penalties |
| Owner | The quality unit | Operations / commercial / procurement |
| Regulatory expectation | Expected for outsourced GxP activities | A business tool, not a GxP requirement |
| Failure mode | Ambiguous quality responsibility → finding | Missed metrics → commercial remedy |
Use a quality agreement to define who is responsible for each GxP quality activity with a supplier or contract manufacturer — it is expected whenever GxP work is outsourced.
Use an SLA to define operational performance expectations (speed, availability, responsiveness) — a business instrument that complements, but never replaces, the quality agreement.
A quality agreement answers "who owns which quality decision?"; an SLA answers "how fast and reliable is the service?". Regulators expect the former for outsourced GxP work; the latter is a commercial tool. The common mistake is burying quality responsibilities in an SLA owned by procurement — quality terms belong in a quality agreement owned by the quality unit.
Quality Agreement vs SLA: frequently asked questions
Common questions on how Quality Agreement and SLA differ and when each applies.
What is the difference between a quality agreement and an SLA?
A quality agreement defines GxP quality responsibilities (release, testing, change control, deviations, audits) between the parties; an SLA defines operational service performance (turnaround, availability, response times). One is a regulatory expectation for outsourced GxP work; the other is a business performance tool.
Can one document be both?
They can be combined, but the quality responsibilities must be clearly owned and approved by the quality unit and not diluted by commercial terms. Many organisations keep them separate so quality obligations are unambiguous and not renegotiated with the commercial deal.
Is an SLA required by GMP?
No. An SLA is a business/operational instrument. GMP expects the quality relationship to be defined (the quality agreement); it does not require service-level metrics, though those are often sensible commercially.