Outsourced Activities in the GDP Environment Part II: Contractual Agreements
Excerpt from the GMP:KnowHow Pharmalogistics (GDP), Chapter 7, Outsourced Activities
3 min. reading time | by Simone Ferrante (Director of Quality at Fisher Clinical Services, Rheinfelden, Germany)
Published in LOGFILE 20/2026
When outsourcing GDP activities, there is a need for concrete delimitation of responsibilities between a client and a contractor. Read more about the goals and the contents of a quality agreement in the following excerpt from GMP:KnowHow Pharmalogistics (GDP).
Why is a Contract Absolutely Essential?
Logistics service providers are not obligated by law to comply with the GDP guidelines.
Therefore, requirements and division of responsibilities between client and contractor must be contractually regulated!
Usually, activities are outsourced by a distribution company (such as a marketing authorisation holder, various manufacturers, or wholesalers) to one or more logistics service providers. However, logistics service providers can also be clients. In this case, subcontracting may only take place based on a written contract.
Many Terms For One Document
The written contract can have various designations, such as
- Technical agreement (TA)
- Quality agreement (QA)
- Quality contract
- Quality assurance agreement (QAA)
- Delimitation of responsibility agreement
- GMP/GDP-contract
What Are the Goals of the Quality Contract?
The quality contract is often a supplementary contract or annex to the commercial contract, in which the economic reconciliations are agreed upon. Financial aspects should not be part of the quality contract. The quality contract should ensure the following:
- Transparency
- Uniform understanding of quality
- Compliance with the currently applicable legal requirements
- Definition of responsibilities
- Binding nature
- Unity
What Should be Included in the Contract?
Primarily, the GxP aspects should be considered, e.g. the distribution of tasks with assumption of responsibility or the handover of documents.
The handling of deviations and changes must also be defined in the quality contract.
Additionally, it is important to state that further subcontracting of activities described in the quality contract may only take place after written approval by the client and only after the successful qualification of the third party.
Who Must Sign the Agreement?
Key personnel from both parties must approve the document with their signatures. These are:
- Responsible person according to GDP
- Quality assurance representative
- Responsible project manager
- Qualified Person (if involved)
All qualified persons (QP) involved should be listed by name and sign the contract.
What Does NOT Belong in the Contract?
All liability issues and business management matters are dealt with in a separate commercial contract. The same applies to the non-disclosure agreement to be assessed by lawyers, which should be signed by both parties at the beginning of negotiations.
Read more soon: Part III: Roles and responsibilities of contract giver and contract acceptor
Do you have any questions or suggestions? Please contact us at: redaktion@gmp-verlag.de
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