Usage Examples
- The Quality Agreement gives the CDMO deviation ownership but leaves final batch release with our quality unit.
- We cannot start the tech transfer until the Quality Agreement for the new fill-finish site is executed.
- That change should have triggered notification under section 6 of the Quality Agreement, and it did not.
What is Quality Agreement?
A Quality Agreement is a written cGMP contract between a drug owner and a contract facility that assigns each quality responsibility (batch release, deviation investigation, change control, audit rights) to one named party, separate from the commercial supply agreement.
A Quality Agreement exists because outsourcing splits execution from accountability. FDA regards a contract facility as an extension of the manufacturer's own facility, so the owner answers for cGMP work it never physically performed. The agreement is the instrument that converts that shared exposure into named, written ownership before a deviation forces the two parties to argue about it.
A Quality Agreement covers the cGMP-relevant decisions: specifications and testing, batch record review and release, deviation and out-of-specification investigations, change control, complaint and recall handling, audit rights, and inspection cooperation. It does not cover price, volumes, delivery, indemnity, or termination, which belong in the supply agreement. Keeping the two separate matters because quality obligations should survive a commercial dispute.
A Quality Agreement is applied through a responsibility matrix: every activity gets one accountable party, one reviewer, and a defined timeline. In practice the contested lines are who approves a change that affects the filed process, who owns a deviation investigation that crosses both sites, and how fast the contract facility must notify the owner of a regulatory inspection.
Not to be confused with
- Supply agreement
- the supply agreement allocates commercial risk (price, volume, delivery, liability); the Quality Agreement allocates cGMP decision rights. Neither overrides the other unless the Quality Agreement states which document controls on conflict.
- Master services agreement
- an MSA is the contracting frame for the whole relationship. A Quality Agreement is a product- and site-specific instrument underneath it, so one MSA usually sits above several Quality Agreements.
- Standard operating procedure
- an SOP tells one company's own staff how to execute a step. A Quality Agreement tells two companies which of them owns the step. An SOP cannot allocate responsibility across a corporate boundary.
- Vendor qualification
- qualification is the evidence-gathering exercise that decides whether to use a contract facility at all. The Quality Agreement governs the relationship after that decision; passing an audit does not define who investigates the next deviation.
No CFR section mandates a document titled "Quality Agreement." These are the underlying obligations it has to discharge.
What you must do
- 1Name the quality control unit at each party and record that it holds authority to approve or reject components, in-process materials, packaging material, labeling, and finished drug product21 CFR 211.22(a)
- 2Put the allocated responsibilities and the procedures behind them in writing, and then follow them as written21 CFR 211.22(d)
- 3Assign which party reviews and approves every production and control record, including packaging and labeling records, before release21 CFR 211.192
- 4Define who investigates an unexplained discrepancy or batch failure, on what timeline, and who closes the investigation21 CFR 211.192
- 5Give the owner the record access, data, and inspection visibility that follow from the contract facility being treated as an extension of the owner's own facility21 CFR 200.10(b)
Common mistakes
Negotiating it through procurement without the quality unit
21 CFR 211.22 places approve-or-reject authority in the quality control unit, so an agreement settled on commercial terms alone assigns duties to people who cannot discharge them. The gap surfaces at the first rejected batch, when nobody has release authority under the document.
Signing the CMO's template without a product-specific responsibility matrix
generic templates leave the expensive items ambiguous: changes that touch the filed process, out-of-specification retest authority, stability ownership, and notification clocks. Ambiguity gets resolved by whoever is not currently under inspection, and the owner is the one holding the application.
Executing it once and never revisiting it
a Quality Agreement goes stale after a site transfer, a process change, or a new product added under the same MSA. An agreement describing a process the facility no longer runs is worse than none, because it documents in writing that the owner stopped paying attention.
When This Matters
- The Quality Agreement gives the CDMO deviation ownership but leaves final batch release with our quality unit.
- We cannot start the tech transfer until the Quality Agreement for the new fill-finish site is executed.
- That change should have triggered notification under section 6 of the Quality Agreement, and it did not.
Frequently Asked Questions
No CFR section requires a document called a Quality Agreement. What 21 CFR requires is that the quality control unit's responsibilities and procedures be in writing, and FDA regards a contract facility as an extension of the manufacturer's own facility, so the owner stays accountable either way.
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