CMC & ManufacturingLast reviewed April 2026

Quality Agreement(Quality Agreement)

A written document defining the cGMP responsibilities and activities between a drug owner and contract manufacturer or testing facility.

Usage Examples

The Quality Agreement between the applicant and CDMO defined change control authority and batch release ownership.
An updated Quality Agreement was executed prior to technology transfer to the new fill-finish site.

What is Quality Agreement?

A Quality Agreement is a written contract between a drug owner (applicant, sponsor, or MAH) and a contract manufacturing, packaging, testing, or distribution organization (CMO, CDMO, CTO, CRO) that defines cGMP responsibilities and quality activities. FDA's 2016 guidance on contract manufacturing arrangements establishes explicit expectations for Quality Agreement content and signals regulatory concern about inadequate agreements.

The agreement typically covers manufacturing process descriptions, specifications, change control responsibilities, deviation and OOS investigation ownership, batch release authority, complaint handling, stability program responsibilities, audit rights, product quality review expectations, and regulatory inspection cooperation. It is distinct from the commercial supply agreement, though often cross-referenced. Well-drafted Quality Agreements reduce disputes, support faster regulatory response, and strengthen Pre-Approval Inspection outcomes.

Regulatory Context

This term appears most often in cmc & manufacturing workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 211, ICH Q10, FDA CONTRACT MANUFACTURING GUIDANCE.

FDAICHHealth Canada

When This Matters

The Quality Agreement between the applicant and CDMO defined change control authority and batch release ownership.
An updated Quality Agreement was executed prior to technology transfer to the new fill-finish site.

Common Mistakes

Failing to align CMC change narratives with current CFR/ICH expectations.
Submitting incomplete control strategy documentation.
Separating manufacturing and regulatory review cycles too late in execution.

Related Regulations

21 CFR 211ICH Q10FDA CONTRACT MANUFACTURING GUIDANCE

Frequently Asked Questions

Not explicitly required by 21 CFR Part 211, but FDA's 2016 guidance on contract manufacturing sets clear expectation that Quality Agreements exist between drug owners and contract facilities. Inadequate or missing agreements are cited in Form 483s and Warning Letters.

Supply agreement addresses commercial terms: quantities, pricing, delivery, payment, liability. Quality Agreement addresses cGMP responsibilities: who does what quality-related activity. They are complementary; both are typically executed for contract manufacturing relationships.

Typically the Quality Unit head of each party plus senior management. Commercial-only signatures are insufficient — the Quality Unit must have reviewed and accepted the cGMP responsibilities. Quality Agreements are reviewed during FDA PAIs.