A quality agreement is a written document setting out each party's responsibilities for the quality aspects of production - separate from, but usually alongside, the commercial supply agreement. It's one of the most important documents in a contract manufacturing relationship, since it defines what happens when things go wrong, not just when they go right. This guide sets out what a quality agreement should cover.
Key points
- A quality agreement should clearly assign responsibility for manufacturing and testing activities to buyer or manufacturer.
- Deviation and out-of-specification handling, with defined notification timelines, is one of the most critical sections.
- Specifications should be referenced in the quality agreement, not left as a separate informal understanding.
- This should be finalised before commercial-scale production begins, not treated as a formality afterwards.
Roles and Responsibilities
The core of a quality agreement is a clear allocation of responsibility for each manufacturing and testing activity - who releases each batch, who performs which tests, and who holds ultimate responsibility for regulatory compliance of the product. Ambiguity here is one of the most common sources of dispute later in a relationship.
Specifications and Test Methods
The agreement should reference the agreed product specifications and test methods directly - see setting quality specifications - rather than leaving them in a separate document disconnected from the quality agreement itself.
Deviation and Out-of-Specification Handling
This is often the most important section in practice: what happens when a batch fails a test or falls outside agreed specification. A strong quality agreement defines a clear notification window - commonly measured in hours rather than days - within which the manufacturer must inform the buyer of a significant deviation, along with the investigation process that follows.
Change Control
The quality agreement should define how changes to the process, formulation, materials or site are proposed, reviewed and approved, so neither party makes a material change unilaterally - see change-control procedures.
Documentation and Retained Samples
Cover expectations for batch record retention periods, certificate of analysis format and content, and retained sample policy - see retained samples and certificates of analysis.
Relationship to the Supply Agreement
A quality agreement typically sits alongside, not instead of, a commercial supply agreement covering pricing, volumes and delivery - see supply agreements. Keep the two documents consistent with each other, since conflicting terms between them can create confusion in a dispute.
What It Covers That the Supply Agreement Does Not
A supply agreement deals with commercial terms - volumes, price, notice, liability. A quality agreement deals with technical and regulatory responsibilities, and trying to combine them usually leaves gaps in both. The quality agreement is where you set out who tests what, who releases batches, how deviations are handled, what documentation is provided and who holds which regulatory duty.
That last point is the one most worth being explicit about. Duties around classification, safety data sheets and registration do not follow automatically from who manufactures, and both parties can reasonably assume the other is handling them.
Provisions Worth Including
Beyond testing and release, cover: retention periods and access rights for batch records and retained samples; what triggers notification to you; how complaints are investigated; the change control process; audit rights; and what happens to documentation if the relationship ends.
Access rights deserve particular attention. Requesting batch records for the first time during a quality investigation is a poor moment to discover you have no contractual right to them, and retention periods should comfortably outlast your product's shelf life.
Questions to Ask a Manufacturer
- Do you have a standard quality agreement template, or do we need to draft one?
- What is your notification timeline for a significant deviation or out-of-specification result?
- How are specification changes handled once we're in production?
- How long do you retain batch records and samples after production?
Frequently Asked Questions
Is a quality agreement legally required?
Not universally required by law for all chemical products, but it is strong commercial and quality practice, and may be expected by certain regulated end markets or customers.
Who typically drafts the quality agreement - buyer or manufacturer?
Either party may propose the first draft, though many manufacturers have a standard template that's then negotiated - ask directly what the manufacturer's usual approach is.
Should we get legal input on a quality agreement?
For any significant or ongoing relationship, having a quality agreement reviewed alongside the supply agreement by someone with relevant experience is a sensible precaution.
Related Guides
Last reviewed: August 2026. Regulation and guidance change — verify anything you rely on against the primary source. Tell us if something here is out of date.
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