Quality Agreements: Who Is Actually Responsible

A quality agreement is the document that divides GMP responsibility between a product owner and a contract facility. It is separate from the commercial contract, and it should be: one is about money and the other is about who decides whether a batch is released.

FDA's guidance on contract manufacturing arrangements sets the expectation, and EU GMP Chapter 7 covers the same ground for outsourced activities.

The point that survives every argument

The owner remains responsible for the product. A quality agreement allocates activities. It does not transfer accountability, and a regulator finding a problem at a contract site will address the owner as well as the facility.

This is why an owner cannot outsource oversight. Delegating the work is permitted; delegating the responsibility for knowing whether it was done correctly is not.

What it has to settle

The useful test for a quality agreement is whether it answers questions that would otherwise be argued about at the worst moment.

• Who releases the batch, and on what evidence.
• Who owns the specification, and who may change it.
• Change control. Which changes the facility may make alone, which require the owner's approval, and how the owner is notified. This is the clause that matters most, because a facility change can alter your reporting obligations without you knowing.
• Deviations and investigations. Who investigates, who approves the conclusion, and when the owner must be told.
• OOS results. Notification timing, and who decides the disposition.
• Complaints, recalls and field alerts, including how quickly information reaches the owner, since the field alert clock is three working days from receipt.
• Audit rights, and for-cause access.
• Regulatory inspections. Notification, and who responds to observations concerning the product.
• Subcontracting. Whether the facility may use another site, and on what approval.
• Records. Retention periods, and access on request.

Where it fails in practice

Signed and filed. The agreement exists, and nobody working on the product has read it. The first time anyone opens it is during a dispute.

Contradicting the commercial contract. Two documents, two definitions of who approves a change, and the parties then argue about which governs.

Silent on notification timing. "The facility shall notify the owner" with no period attached is unenforceable in practice and useless against a three-day clock.

Never updated. The product changed, the process changed, the agreement did not.