Quality & Technical Agreements
The document that allocates quality responsibility between two organisations: roles, records, release, deviations, complaints, changes, audit rights, subcontracting and termination. Its whole function is to decide who does what when something goes wrong, written at a time when nothing has. Where it is a template signed by procurement, the ambiguity surfaces during a deviation — the worst possible moment to discover that neither party thought they owned the decision.
What an explainer is not
A topic explainer is SPEQ’s synthesis of what a practice involves, cited to the standards that govern it. It does not reproduce their text, and it does not determine which of them apply to your product or process.
[ POSITION IN THE FRAMEWORK ]
7 DIMENSIONS · 22 LINKSA technical agreement is the document that decides who is accountable at the moment something goes wrong — which is why the useful test is not whether it is signed, but whether either party has read it since.
06 · QUALITY MATURITY — QUALITY & TECHNICAL AGREEMENTS, REACTIVE TO ADAPTIVE
A commercial contract exists with quality clauses inside it. Nobody in quality on either side has seen it.
A separate quality agreement is signed at onboarding, generic in its allocation, and unchanged as the relationship evolved.
Responsibilities are allocated activity by activity with no gaps and no duplication, and the agreement matches what each party actually does.
The agreement is exercised — deviation notification, change notification, audit rights have been used — and reviewed when the scope changes rather than on a renewal date.
It is a working document both quality units operate from, so a deviation at the supplier arrives already routed to the people who need it.
SPEQ’s shared five-stage progression, labelled synthesis — not the FDA QMM rating scale. Where does your organization sit? Score your quality system →
07 · REGULATORY & EVIDENCE
GOVERNING STANDARDS · 4
Derived from the 4 standards SPEQ maps to this subject, across 3 regulatory bodies: FDA, ICH, EMA.
RECORDS & OBJECTIVE EVIDENCE
- The quality agreement, with activity-by-activity responsibility allocation
- Evidence the agreement matches the activities actually performed
- Records of notifications made under it — deviation, change, out-of-specification
- Review records where scope changed, and the resulting amendments
- Audit rights exercised, and what was done with the findings
COMMON INSPECTION FINDINGS
- Activities performed by the supplier that the agreement does not allocate to anyone
- A generic agreement identical across suppliers doing very different work
- Deviations at the supplier not notified, because notification criteria were never defined
- An agreement unamended through years of scope change
- Both parties believing the other is responsible for a specific control
Separate from the commercial contract, and deliberately so
A quality agreement and a supply agreement serve different purposes and are signed by different people. The commercial contract allocates money and liability; the quality agreement allocates GxP responsibility, and it should be owned and signed by the quality units on both sides. Folding quality terms into a commercial annexe negotiated by procurement produces terms that read as commercial protections rather than as operational allocations.
EU GMP Chapter 7 requires a written contract between contract giver and contract acceptor covering the outsourced GMP activities, and Annex 16 makes the Qualified Person’s certification dependent on knowing that arrangement is in place and adequate. The QP cannot certify what is happening at a contract site without an agreement establishing what that site is responsible for.
The clauses that are actually used
Most quality agreements are long and most disputes turn on a few clauses: who investigates a deviation and who decides its product impact; who owns the complaint and the reportability decision; what changes require prior approval versus notification, and within what period; who releases, and against what; audit rights and their frequency; whether subcontracting is permitted and on what terms; and what happens to records and material on termination.
Each of those is a decision about a moment that will occur. A responsibility matrix listing activities against parties with no accompanying detail about who decides when the parties disagree is the most common form and the least useful, because disagreement is precisely the case the agreement exists to settle.
Subcontracting is where the chain becomes invisible
A contract manufacturer that subcontracts testing, sterilisation or packaging without the contract giver’s knowledge has extended the supply chain past the point the agreement covers. The clause that prevents this is a prohibition on subcontracting without prior written approval, with the subcontractor subject to equivalent terms — and it is one of the most frequently absent.
Where it is absent, the contract giver may be qualified against an organisation that performs none of the critical operations. The audit visited a site; the work happened elsewhere. Establishing the actual chain at qualification, and requiring notification of any change to it, is the only reliable way to keep the agreement matched to reality.
SPEQ interpretation — an agreement nobody reads during an event has failed
The practical test of a quality agreement is not whether it exists but whether anyone consults it during a deviation. In most organisations the agreement is filed after signature and the operational relationship runs on precedent and personal contact — which works until the people change or the parties disagree.
The useful practice is to walk the agreement through a scenario at signature and again periodically: a critical deviation at the contract site, a complaint traced to their operation, a change they propose that affects the filing. Answer each from the document. Every question the document cannot answer is a gap identified in a conference room rather than during an event, and it is the cheapest form of quality-agreement review available.
FREQUENTLY ASKED
Should the quality agreement be part of the supply contract?
No. They allocate different things and should be owned and signed by different people — the commercial contract allocates money and liability, the quality agreement allocates GxP responsibility and belongs to the quality units on both sides. Folded into a procurement annexe, quality terms come out reading as commercial protections rather than operational allocations.
Which clauses actually get used?
Who investigates a deviation and decides product impact; who owns a complaint and its reportability decision; which changes need prior approval versus notification and within what period; who releases and against what; audit rights; subcontracting terms; and what happens to records and material at termination. A responsibility matrix with no detail on who decides when parties disagree is the least useful common form.
Why does subcontracting need explicit control?
Because a contract manufacturer that subcontracts testing, sterilisation or packaging without approval extends the chain past what the agreement covers — and the contract giver may be qualified against an organisation performing none of the critical operations. Prohibition without prior written approval, with equivalent terms flowed down, is the clause and it is frequently absent.
How do you test whether a quality agreement is any good?
Walk a scenario through it: a critical deviation at the contract site, a complaint traced to their operation, a change they propose affecting the filing. Answer each from the document. Every question it cannot answer is a gap found in a conference room instead of during an event.