Technical Agreement (Quality Agreement) and outsourced activities in pharmaceutical manufacturing

Outsourcing the manufacture of a medicinal product to an external entity does not transfer responsibility for the product. It transfers only the performance of activities—and only on the condition that both parties precisely describe who is responsible for what. The document that does this is the technical agreement, known in industry practice as the Quality Agreement.

Many brand owners treat it as an appendix to the commercial contract, signed at the end of negotiations. This is a costly mistake. The technical agreement is a requirement of the quality system, and deficiencies in it are among the non-conformities more frequently identified during inspections. In this article, we explain what it should contain and how to verify a partner before signing it if you are planning contract manufacturing of medicinal products.

Outsourced activities in the GMP system – Chapter 7

The principles of cooperation in outsourced activities are governed by Chapter 7 of the EU Guidelines for Good Manufacturing Practice. This chapter uses two terms: Contract Giver, meaning the commissioning party, and Contract Acceptor, meaning the entity accepting the contract. Its scope of application is broad—it covers not only manufacturing, but also analysis, packaging, storage, and validation.

The key principle is unequivocal: the Contract Giver remains ultimately responsible for oversight of the outsourced activities. It must implement processes that ensure such oversight and base them on quality risk management. Before entrusting tasks, it is obliged to assess three things on the partner’s side: the legality of operations, the suitability of resources, and actual competence.

On the side of the Contract Acceptor, the obligations are equally specific. The manufacturer must have appropriate premises, equipment, knowledge, and personnel, and must refrain from introducing any unagreed changes that could affect the quality of the activities performed.

What a good technical agreement must contain

A technical agreement does not describe prices or volumes. Its sole purpose is to assign each quality-related activity to a specific party. A well-structured document leaves no areas in which both parties assume that someone else will take care of them.

The minimum scope you should find in an agreement with your manufacturer includes:

• purchasing, qualification, and release of materials – who selects material suppliers, who qualifies them, and who decides to release a batch for production;
• scope of testing and where it is performed – release testing, stability testing, and external laboratories used by the manufacturer;
• batch release rules – what set of documents the Qualified Person receives and within what timeframe input data are provided;
• handling of deviations, changes, and complaints – reporting thresholds, deadlines for notifying the Contract Giver, and the procedure for jointly approving corrective actions;
• product recall procedure – the decision-making path and emergency contacts operating outside working hours;
• rules for archiving and access to documentation – retention periods and the method for transferring records after the cooperation ends.

A practical test of the quality of such a document is a simple scenario: imagine that, in the middle of a batch, an out-of-specification result appears for a raw material. A good technical agreement immediately answers who conducts the investigation, within what timeframe they inform the other party, and who ultimately decides the further fate of the batch. If the answers have to be sought in a phone call, the document needs to be rewritten.

The area of raw materials requires particular attention, because this is where discrepancies in expectations most often arise. The criteria worth following are described in our guide to the selection and quality control of pharmaceutical raw materials.

Audit and qualification of the manufacturer before signing the agreement

The assessment of the partner should precede the technical agreement, not follow it. The starting point is formal verification: the scope of the manufacturing authorisation and the validity of the GMP certificate in the EudraGMDP database. The scope of the authorisation must cover exactly the pharmaceutical form and the operations you need—general authorisation to manufacture does not mean authorisation to perform every activity.

The next step is a qualification audit at the site. During the audit, the maturity of the quality system is assessed: the way batch documentation is maintained, the handling of deviations and changes, equipment qualification, and personnel competence. It is worth requesting the Site Master File even before the visit—the same document forms the basis for the procedure for obtaining a manufacturing authorisation and for the inspection by the Chief Pharmaceutical Inspector, which results in the site’s GMP certificate.

Manufacturer qualification is not a one-off activity. The technical agreement should provide for periodic audits and ad hoc audits in response to a serious deviation or a series of complaints. Without this provision, your oversight of outsourced activities remains merely a declaration.

Technical agreement and commercial agreement – two different documents

The commercial agreement regulates prices, volumes, delivery dates, and contractual penalties. The technical agreement regulates quality. Combining both into a single document makes it more difficult to update, because every change to the price list would then require the quality provisions to be re-agreed with the QA departments of both parties.

In practice, these documents are also handled by different people. The commercial agreement is signed by management, while the technical agreement is approved by the persons responsible for quality on both sides. This distinction matters during an inspection—the inspector asks for the technical agreement and expects an operational document, not a contract with confidentiality clauses.

The technical agreement should also be a living document, reviewed periodically and updated after every significant change in the process, manufacturing site, or scope of testing. We show what such a process looks like from an organisational perspective in our article on cooperation with a CDMO partner step by step.

Establish the rules of cooperation before the first batch starts

A well-prepared technical agreement shortens every subsequent discussion about a deviation, complaint, or process change—because the answers are already written into it. Eubioco, together with Laboratorium Galenowe Olsztyn, conducts contract projects based on a quality system confirmed by a GMP certificate and ISO 22000:2018, with clearly separated responsibilities on the part of the Contract Giver and the manufacturer. Would you like to discuss the scope of a technical agreement for your product? Email us at sprzedaz@eubioco.eu and arrange a call with our quality team.

BIBLIOGRAPHY

1. European Commission (2013). EudraLex – Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Chapter 7: Outsourced Activities. [online] Available at: https://health.ec.europa.eu/document/download/8efedeb3-9c78-4a57-b489-de7b051fc1a7_en [accessed online: 13 August 2026]
2. Regulation of the Minister of Health of 9 November 2015 on the requirements of Good Manufacturing Practice (Journal of Laws of 2022, item 1273, as amended).
3. Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2001, No. 126, item 1381, as amended), Chapter 3.
4. International Council for Harmonisation (2008). ICH Q10: Pharmaceutical Quality System. [online] Available at: https://www.ich.org/page/quality-guidelines [accessed online: 13 August 2026]
5. European Medicines Agency (2026). EudraGMDP – database of manufacturing authorisations and GMP certificates. [online] Available at: https://eudragmdp.ema.europa.eu/ [accessed online: 13 August 2026]