Quality Agreement: the quality contract that allocates GMP responsibilities

A quality agreement is a contractual document that precisely defines who does what in terms of quality between two pharmaceutical companies working together, for example a contract giver (the MAH) and its manufacturing subcontractor. This quality agreement sets out the GMP responsibilities of each party, activity by activity, to ensure the compliance of manufactured medicines. This guide explains its content, scope, differences with the supply agreement and its practical implementation.

Table of Contents

1. What is a quality agreement?

2. What does a quality agreement contain and what is its scope?

3. What is the difference between a quality agreement and a supply agreement?

4. How to implement an effective quality agreement?

5. FAQ on quality agreements

What is a quality agreement?

A quality agreement is a contract that formally allocates quality responsibilities between two actors in the pharmaceutical industry engaged in an outsourced activity. It covers every quality aspect, from manufacturing to analytical control, specifying activity by activity who decides, who executes and who documents. Without it, the release of a batch or the management of a deviation remains without a designated responsible party.

As soon as a pharmaceutical company entrusts a GMP activity to a third party, Chapter 7 of the European GMP guidelines requires that the allocation of responsibilities be documented in writing. Annex 16 further specifies requirements related to batch release by the Qualified Person. The quality agreement is that document. Without it, no one knows who releases a batch, who manages a deviation or who approves a change.

In practice, this quality contract applies to pharmaceutical manufacturing as well as analysis, packaging, storage and distribution. Each covered activity must be listed with a clearly identified responsible party.

The term QTA (Quality Technical Agreement) refers to exactly the same document in pharma supplier jargon. The question "What is a QTA in pharma?" is therefore equivalent to asking what a quality agreement with a reinforced technical component is, often used when the service provider is an API manufacturer or a CMO.

While quality agreements are often associated with the GMP context, they also exist in GDP (Good Distribution Practices). Whenever a wholesale distributor, logistics provider or carrier takes on a distribution activity on behalf of an authorisation holder, a GDP quality agreement is required. It covers responsibilities related to storage conditions, transport, temperature management, returns and complaints. A dedicated article on the specificities of GDP quality agreements is in preparation.

What does a quality agreement contain and what is its scope?

The scope of a quality agreement specifies the activities covered, the products concerned and the sites involved. The body of the document then assigns each GMP responsibility through a matrix, from deviation management to batch release. An agreement without an explicit matrix leaves grey areas that become problems during an inspection.

The following sections are found in the majority of robust documents.

• Scope: products, sites and activities covered, and activities explicitly excluded

• GMP responsibility matrix by activity

• Management of deviations, CAPAs and complaints

• Change control and prior notification timelines

• Batch release and the role of the QP

• Equipment and infrastructure maintenance

• Validation policy (equipment, processes, analytical methods)

• Audits, self-inspections and site access rights

• Document retention and archiving

Explicitly listing activities not covered is as important as listing those included: it is this clause that prevents conflicts during an unannounced audit.

Equipment and infrastructure maintenance

A solid quality agreement specifies who is responsible for preventive and corrective maintenance of equipment used within the scope of the outsourced activity, and at what frequency. It also defines who is accountable for confirming that equipment remains in a qualified state, and what procedure applies when a faulty or out-of-qualification piece of equipment must be reported to the contract giver. Unmaintained infrastructure or equipment taken out of its qualified state without notification constitutes a direct risk to product quality and, in the event of an inspection, a major non-conformity.

The quality agreement should also address pest control: who is responsible for implementing and monitoring the pest control programme at the service provider's site, at what frequency inspections are conducted, how findings are documented and escalated, and within what timeframe a critical pest control issue must be reported to the contract giver. Pest control is a GMP requirement that directly impacts product integrity, particularly for storage and packaging activities, and its responsibilities must be explicitly allocated in the agreement.

Validation policy

The quality agreement must define each party's expectations regarding validation: who drafts protocols, who approves them, who conducts the studies and who archives the results. This covers equipment qualification (IQ, OQ, PQ), manufacturing process validation and validation of analytical methods used for release testing. The revalidation policy, particularly in the event of a process or equipment change, must also be explicitly included.

A solid quality agreement also includes essential annexes, which cover at minimum: the list of key contact persons from each party, the critical subcontractors on which both parties have agreed, the list of products covered by the agreement, and the expected specifications for the products or materials covered (release specifications, analytical acceptance criteria, packaging requirements). These annexes provide a concrete operational basis for the document and facilitate its day-to-day application. A major advantage of annexes is that they can be updated independently of the main body of text, offering great flexibility in management. Nevertheless, any modification within the scope covered by an annex makes its update mandatory: an obsolete annex is equivalent to a partially void quality agreement.

Roles and responsibilities of the MAH

The MAH (Marketing Authorisation Holder) remains responsible for placing medicines on the market. It holds the specifications, validates major changes and audits its service provider at a frequency defined in the agreement. It maintains the overall view and pharmaceutical responsibility over the finished product's lifecycle.

Roles and responsibilities of the service provider

The service provider executes activities according to agreed procedures, notifies any deviation within the timeframe stipulated in the agreement (often 24 to 48 hours for critical deviations), makes no changes without written agreement and provides access to its facilities during audits. Its quality manager oversees this daily GMP compliance.

Roles of the QP and RP

The Qualified Person (QP) certifies and releases batches based on the guarantees provided by the quality agreement: if the agreement does not cover a manufacturing step, the QP cannot legitimately release the batch in question. The Responsible Person (RP), on the GDP distribution side, verifies that transport and storage conditions comply with the agreement before each sensitive shipment. To learn more about these roles, visit our QP/RP mentoring.

What is the difference between a quality agreement and a supply agreement?

The quality agreement addresses GMP responsibilities and quality aspects, while the supply agreement governs commercial conditions: price, volumes, timelines and penalties. Both documents are complementary and must never contradict each other. In the event of a conflict on a technical point, the quality agreement takes precedence.

Confusing the two is a common mistake during contract negotiations, often because purchasing teams drive the supply agreement without involving quality teams. The table below clarifies what each document covers.

A quality contract can exist without a supply agreement, for example for a simple subcontracted analytical laboratory. The reverse is risky: delivering or performing a service without a prior quality agreement exposes both parties during an inspection, with responsibility falling back on the MAH. Beyond the regulatory risk, the absence of a quality agreement creates an uncontrolled situation that poses a direct risk to the patient. The patient relies on the entire pharmaceutical supply chain to receive a medicine that is of quality, safe and effective: this is precisely one of the fundamental objectives of GMP, which places patient protection at the heart of every requirement.

How to implement an effective quality agreement?

Implementing a quality agreement follows four steps: define the scope between both parties, draft the responsibility matrix activity by activity, have it validated by quality managers on both sides, then sign it and schedule a periodic review. The agreement must be reviewed at least every two years, or whenever a change in site, process or regulation occurs.

The key European reference frameworks, notably Chapter 7 of the EMA Good Manufacturing Practices and the EudraLex Volume 4 guidelines, provide a structured framework for drafting quality agreements. These texts serve as a starting point, never as a copy-paste template: each clause must be adapted to the actual activity and the specific characteristics of the product.

Key steps for drafting a quality agreement

1. Define the scope: identify the products, sites and activities covered, as well as those explicitly excluded

2. Map responsibilities: build the matrix activity by activity with both quality teams

3. Draft operational clauses: deviations, changes, maintenance, pest control, validation, audits, archiving

4. Complete the annexes: key contacts, product list, specifications, critical subcontractors

5. Validate and sign: have the document approved by quality managers and, where applicable, by the QP of both parties

6. Schedule the periodic review: include a systematic review date within the document itself

Best practices and pitfalls to avoid

The following are the most common mistakes quality managers encounter when drafting or reviewing an agreement.

1. Leaving shared responsibilities without a designated decision-maker: in the event of a deviation, no one takes the decision

2. Failing to list activities not covered, which creates ambiguity during an audit

3. Not revising the document following a change of site or process, rendering the agreement de facto obsolete

4. Signing a generic template without a matrix adapted to the specific product and service provider

5. Setting vague deviation notification timelines that slow down the QP's decision-making

6. Not specifying responsibilities related to equipment maintenance, pest control and validation policy, leaving these critical aspects without contractual framework

7. Including incomplete or outdated specification annexes, making acceptance criteria inapplicable in practice

These decisions are best worked through in real situations. Our GMP training and GDP training include practical case studies on drafting and reviewing quality agreements.

For QP and RP professionals in their daily work

A QP does not sign blindly: before any release, they verify that the quality agreement covers the manufacturing step in question, that deviations have been escalated within the agreed timelines, that no unnotified change has taken place at the service provider's site, and that critical equipment is properly maintained and within its validated state. An RP checks the transport and temperature clauses before each sensitive shipment, particularly for cold chain products. This reflex transforms a dormant contractual document into a daily decision-making tool. Our pharmaceutical quality support helps establish these routines.

When should a quality agreement be reviewed or updated?

A quality agreement is not a static document. A systematic review must be planned at least every two to three years. It becomes immediately mandatory in the following situations:

• Change of manufacturing or storage site at the service provider

• Major modification of the manufacturing process or product

• Change in applicable regulations (new GMP version, new EMA annex, etc.)

• Change of QP or quality manager at either party

• Extension of the service scope to new products or new activities

• Regulatory inspection that generated observations related to the management of outsourced activities

An annual review, even in the absence of an identified change, is a best practice: it confirms that the agreement remains suited to operational reality and that both parties have acknowledged it.

FAQ on quality agreements

What is a quality agreement?

A quality agreement is a contract that allocates quality responsibilities between two pharmaceutical companies working together, such as a contract giver and its subcontractor. It specifies who manages manufacturing, deviations, changes, equipment maintenance, pest control, validation policy and batch release.

What is the difference between a quality agreement and a supply agreement?

The quality agreement covers quality and GMP aspects, while the supply agreement governs commercial aspects such as prices and volumes. They are complementary, and the quality agreement takes precedence in the event of a conflict on technical matters.

What is a QTA in pharma?

A QTA (Quality Technical Agreement) is the technical name for a quality agreement among pharma suppliers. It refers to the same contractual document that formalises quality responsibilities between the parties of an outsourced activity.

What is a quality contract?

A quality contract is a common synonym for quality agreement. It sets out in writing the quality objectives and roles of each party to ensure GMP compliance of the products concerned.

Do quality agreements also exist in GDP?

Yes. Whenever a distribution activity is entrusted to a third party, a GDP quality agreement is required. It covers responsibilities related to storage, transport, temperature management, returns and complaints. A dedicated article on the specificities of GDP quality agreements is in preparation.

What is the validity period of a quality agreement?

A quality agreement has no legally fixed duration, but it must be reviewed at least every two to three years. It must also be updated immediately in the event of a change of site, process, regulation or scope of service. An annual review is recommended as a best practice.

Who must sign a quality agreement?

A quality agreement must be signed by the quality managers of both parties, and in some cases by the Qualified Person (QP) when batch release is at stake. Purchasing and commercial management are not signatories to the quality agreement, even if they may be signatories to the associated supply agreement.

Three key takeaways:

1. The quality agreement allocates quality responsibilities (GMP or GDP); the supply agreement covers commercial aspects

2. The scope, role matrix, maintenance and pest control sections, validation, specification annexes and periodic review make it a living document

3. QPs and RPs use it as a decision-making tool, not as a formality

To master the drafting and review of a quality agreement in your GMP or GDP context, discover the training programmes and mentoring offered by MentorinQ.

Written with the expertise of MentorinQ, a GMP/GDP training and mentoring company founded by Nelly Slegers, a practitioner in pharmaceutical compliance and in supporting QP/RP roles in the pharmaceutical industry.