Quality Agreements

Your quality agreement — reviewed, or built to fit.

Two ways in. Have an agreement with your manufacturer? Get an independent opinion on whether it actually protects you. Don’t have one that fits how you make the product? We build it — every GMP responsibility assigned to the party that can carry it.

The trendWhere the responsibility lands

When you outsource manufacturing, you don’t outsource the responsibility. FDA holds the brand owner accountable for the product no matter who makes it — and the quality agreement is the document meant to say who does what. The gap is usually silent: a duty no one was assigned, found when an inspection or a recall asks who owned it.

Source · FDA guidance, Contract Manufacturing Arrangements for Drugs: Quality Agreements

What this is

Who owns each GMP responsibility — and whether anything critical is falling in the gap.

A quality agreement is the one document that divides GMP duties between you and the contract manufacturer, packager, or lab that makes your product. We judge the one you have, or build the one you’re missing — every responsibility mapped to the party that can actually carry it, and any that can’t be cleanly assigned named rather than left silent.

Quality Agreement Review

An independent regulatory opinion on the quality agreement you already have — does it actually protect you, or does it leave you exposed for what your manufacturer does.

What this covers

Responsibility allocation — brand / CMO
GMP responsibility-gap analysis
Contract manufacturer / packager / lab agreements
Own-label distributor GMP responsibilities
Deviation, OOS & complaint allocation
Change-control & sub-supplier qualification

What you get back

A signed written opinion you can act on — renegotiate a clause, close a gap, or file it — before an inspection or recall forces the question of who was responsible. We read every GMP responsibility against the way your product is actually made, and check that each duty sits with a party that can carry it. Then we check the critical ones — stability, complaint handling, out-of-spec investigations, change notification, sub-supplier qualification — for anything falling into the gap between you and the manufacturer. Not a free template that allocates nothing to your relationship, and not a lawyer pricing the contract terms by the hour. A fixed-price regulatory read of who owns each GMP duty, from a firm that reads the GMP responsibilities, not the contract terms.

What you send

The quality agreement itself, plus enough of your arrangement — who manufactures, packages, tests, and releases the product — for the responsibilities to be checked against the relationship they govern. Quality Agreement (TQA)Your quality agreement with the manufacturer, packager, or lab — the document that divides the GMP responsibilities between you and them.Also called: TQA, technical / quality agreement, supply quality agreementFull details on the Records page

If the agreement can’t be given a clean opinion on what you send, you get a straight report on what’s missing instead, at the same fee.

What a review catches

A worked agreement — the clauses that read complete and still leave you exposed.

Four findings from a constructed brand-owner / contract-manufacturer agreement. Each reads fine on its face; each hides a responsibility that isn’t really owned. The blander the clause, the more it tends to hide.

Specimen drawn from a constructed Northbank / Ridgeline manufacturing agreement — more worked cases in the library

1Stability is “covered” — and assigned to no one.

In the agreement · “Stability testing shall be performed in accordance with each party’s standard procedures.”

It reads covered, but it names no owner — nobody is actually assigned to pull, store, and read the stability timepoints. When FDA asks who supports the expiry date printed on your label, both parties point at the other, and no data exists.

21 CFR 211.166 · FDA QA Guidance

2An out-of-spec clause that lets a failing lot be retested until it passes.

In the agreement · “The manufacturer may invalidate an out-of-specification result upon identification of obvious error and report the confirming retest.”

“Obvious error” is undefined and self-judged. It lets a failing lot be retested until it passes, with you never seeing the original result — the exact pattern a data-integrity inspection is built to find.

21 CFR 211.192 · Barr Laboratories

3Change notification runs a year too late.

In the agreement · “The Brand Owner will be notified of significant changes at the annual review.”

A supplier swap, a process change, or a new sub-contractor can happen and you learn of it up to a year later — after the affected lots have shipped. Change control that notifies after the fact isn’t change control.

21 CFR 211.100 · FDA QA Guidance

4Recall is your responsibility — with none of the data behind it.

In the agreement · “Recalls shall be the responsibility of the Brand Owner.”

You’re named, but the manufacturer — who holds the traceability, the distribution records, and the contact tree — is given no duty to hand any of it over. When a recall has to move in 24 hours, “responsibility” with no data behind it is a clause, not a plan.

21 CFR Part 7 · FDA QA Guidance

Your review$2,500flat fee · fixed price

Quality Agreement Drafting

No agreement, or one that doesn’t fit how you make the product? We build it from your actual arrangement — every GMP responsibility placed with the party that can carry it, and any that can’t be cleanly assigned named rather than buried. One flat fee.

What this covers

Responsibility allocation — brand / CMO
GMP responsibility-gap analysis
Contract manufacturer / packager / lab agreements
Own-label distributor GMP responsibilities
Deviation, OOS & complaint allocation
Change-control & sub-supplier qualification

What you get back

The built quality agreement, ready for your counsel to review and for you to finalize with your manufacturer. Every GMP responsibility — manufacturing, packaging, labeling, testing, release, stability, complaints, deviations and out-of-spec investigations, change control, and sub-supplier qualification — assigned to the party positioned to carry it, so no duty is left silently unowned. You stay responsible for the product; the agreement makes sure each duty behind it has an owner. Not a free template that assigns nothing to your real relationship, and not a law firm’s hourly draft on terms a regulator never reads. And where the way the work is split leaves a responsibility no one can truly own, you get that named instead of papered over.

What you send

The basis we build from: who manufactures, packages, tests, and releases the product, and how the quality responsibilities are meant to be split.

What this builds

The same relationship, built right — the calls we made, and why.

Nothing to catch on a build: you send how the product is actually made, and the reasoning is the work. Here is the same constructed Northbank / Ridgeline relationship, brought to us to draft from scratch, and the call we made on each responsibility.

You send who makes, tests, and releases — more worked relationships in the case library

01Stability got a named owner, a location, and a trigger.

We assigned stability to the party that holds the retention samples and reads the data, named the storage conditions and the pull schedule, and tied a failing timepoint to a defined out-of-spec path — so the expiry date on the label has someone standing behind it, not two parties pointing at each other.

21 CFR 211.166

02Out-of-spec ownership assigned, and the invalidation loophole closed.

Deviation and OOS investigations sit with the manufacturer’s quality unit, the original result and the investigation must reach you, and “invalidate on obvious error” is struck — a result stands unless a documented, root-caused investigation says otherwise.

21 CFR 211.192

03Change notification moved to before, not after.

The manufacturer must notify you before any change to process, supplier, sub-contractor, or site — not at an annual review — with a defined window for you to object before affected lots are made.

21 CFR 211.100 · FDA QA Guidance

!And the honest fork, up front: one duty had no home — so we named it, not buried it.

Northbank has no regulatory function and Ridgeline won’t accept product classification and claims. That responsibility can’t be cleanly assigned to either party as things stand. Rather than park it on someone who can’t perform it and call it covered, the agreement names it as an open gap for you to close — hire it, or contract it out — so the decision is on the table, not hidden in a clause.

FDA QA Guidance

Built agreement$3,000one relationship · flat fee

Common questions

Straight answers.

Isn’t this the contract review my lawyer already does?

A lawyer reads indemnification, liability, and commercial terms. We read who owns each GMP responsibility against the way your product is actually made — the regulatory allocation a contract lawyer isn’t looking at and an investigator is. Same document, a different read.

Is this legal advice?

No — it’s an independent regulatory opinion, or for the build a regulatory deliverable, not legal counsel. It doesn’t draft or rule on indemnification, liability, or commercial terms, and it creates no attorney-client relationship. For the build, have your own counsel review it before you sign.

Can’t I just use a free template?

A template allocates nothing to your actual manufacturer. The hard part — the part the template skips — is making every GMP duty land on the party that can carry it, with nothing left in the gap, for a relationship only you can describe.

What if a responsibility can’t be cleanly owned?

You get it named plainly, at the same fee — on the review as a gap, on the build as an open item for you to close — instead of papered over and assigned to a party that can’t actually perform it.

Do you negotiate with my manufacturer?

No. We give you the opinion or the built agreement; taking it to your manufacturer and agreeing terms is yours. Our job is to make sure the regulatory allocation is right before you do.

Review or drafting — which do I need?

Have an agreement and want to know whether it protects you: the review. Have none, or one that doesn’t fit how you actually make the product: the drafting.

Where to go from here.

Regulatory work product, not legal advice. A deliverable is prepared from the records you submit and is not legal counsel, not a guarantee of any regulatory or inspection outcome, and forms no attorney-client relationship. It reads or builds the GMP responsibility allocation — it does not set indemnification, liability, or commercial terms, and is not a GMP audit, an analytical test, or the release decision. Where the records provided can’t support a defensible result, we deliver a findings report on what’s missing instead. Northbank Consumer Health and Ridgeline Contract Manufacturing are a constructed teaching example; no real company is depicted.