Outsourced Activities in the GDP Environment, Part III: Contract Giver and Contract Acceptor

Excerpt from the GMP:KnowHow Pharmalogistics (GDP), Chapter 7, Outsourced activities

5 min. reading time | by Simone Ferrante (Director of Quality at Fisher Clinical Services, Rheinfelden, Germany)
Published in LOGFILE 22/2026 

For any outsourced GDP activity, there is a need for delimitation of responsibilities between a client (contract giver) and a contractor (contract acceptor). Read more about their roles and responsibilities in the following excerpt from GMP:KnowHow Pharmalogistics (GDP).

Roles and responsibilities of the contract giver

The contract giver is responsible for his outsourced activities. That means that he has to ensure that the contract acceptor performs the activity according to the given instructions and holds the required permits. Furthermore, the contract giver is responsible for assessing the contract acceptor's ability to successfully perform the work and to ensure, through contract design and audits, that the principles of GMP or GDP and/or EN ISO 13485 are followed. 

The type and scope of the outsourced activity(ies) must be agreed upon and defined between the parties involved.

Caution: 

In the case of outsourced GMP activities, the responsibility of the qualified person (or the pharmaceutical entrepreneur) under pharmaceutical law cannot be delegated. 

This delimitation of responsibility must be clearly and completely defined in the associated contract without any overlapping of competences. 

What are the obligations of the contract giver?

If the contract giver is a pharmaceutical entrepreneur or an economic operator within the context of the Medical Device Regulation ((EU) 2017/745), he is responsible for compliance with the relevant regulations. This includes not only ensuring the product quality itself but also the legality of the distribution and presentation of his products. The contract giver is responsible for the correctness and completeness of the outer packaging content (secondary packaging), including storage instructions and package insert.

The contract giver shall provide the contract acceptor with all information necessary to perform the outsourced activities in accordance with the specific product requirements and other relevant requirements.

Pharmaceutical companies and pharmaceutical wholesalers are obliged to ensure an adequate supply of medicines for patients. Supply shortages must be avoided within the scope of their responsibility.

The contract giver must conclude contracts with the contract acceptors before they take over the activity.

What is the role of the logistics service provider?

A logistics service provider performs activities for his customers (economic actors in the supply chain) and is the contract acceptor in this constellation. To be able to deliver a fully comprehensive service, the logistics service provider cooperates with other service providers/suppliers at certain points. With this step, the logistics service provider becomes the contract giver.

In this case, the logistics service provider has a high level of responsibility towards his customers. He has to ensure that the agreed quality will also be delivered by his contract acceptors.

Subcontracting of an activity that has been assigned to the logistics service provider by a quality contract (e.g., between the logistics service provider and the pharmaceutical company) is only allowed if this contract enables subcontracting and is in agreement with the customer.

The responsibility for supplier qualification, which for example applies to the subcontracting of transport orders, must already be specified in the quality contract with the logistics service provider's customer.

Roles and responsibilities of the contract acceptor

The contract acceptor shall have adequate premises, equipment, expertise, and experience as well as competent personnel to perform the contracted activities. He must allow the contract giver to conduct audits. The contract acceptor shall comply with the relevant GxP principles, guidelines, and standards.

Furthermore, the contract acceptor must not carry out any activities that could affect the quality of the products handled on behalf of the contract giver. The contract giver shall always be informed of any possible impact on the quality of his products.

Sub-sub-contracting

The contract acceptor is prohibited from subcontracting the contracted tasks assigned to him without the knowledge of the contract giver. The possibility as well as the responsibility for subcontracting of tasks must be contractually defined in advance.

Monitoring of medicinal products and medical devices – What the contract acceptor should know

Even if it is not explicitly described in the contract, the contract acceptor should know that the entire supply chain of medicinal products and medical devices is monitored by the authorities. The competent authority has specific power to carry out this monitoring, for example to 

• carry out unannounced inspections, including at the contract acceptor's premises,
• seize documents and/or products, and
• take pictures. 

The contract acceptor must, therefore, ensure that the competent authority always has access to the premises and the relevant product documentation. In order to maintain a cooperative relationship with the contract giver, such events must be reported immediately and support must be provided for any necessary measures.

Do you have any questions or suggestions? Please contact us at: redaktion@gmp-verlag.de