Outsourcing in GDP: Responsibilities, Risks, and Regulatory Expectations

Outsourced Activities in Good Distribution Practice (GDP): A Critical Responsibility

Outsourcing is common, but it doesn't mean offloading responsibility.

Under EU GDP guidelines, when a wholesale distributor outsources any activity (e.g., storage, transportation, or repackaging), they retain full responsibility for ensuring that these activities comply with GDP standards.

Whether working with third-party logistics providers or external contractors, key expectations include:

• Written Quality Agreements that clearly define roles, responsibilities, and expectations.

• Qualification and ongoing monitoring of service providers to ensure compliance.

• Documentation and traceability at every step to guarantee product integrity and patient safety.

Key takeaway:

Outsourcing is a strategic tool, but it must be governed by robust oversight, clear contracts, and a strong quality system.

As regulators tighten oversight, companies must treat outsourced GDP activities with the same rigour as in-house operations.

Have you reviewed your outsourced partner agreements recently?

https://www.traingdp.co.uk/