GDPGxP

GDPGxP is a term used in pharmaceutical and life sciences to describe an integrated framework that combines Good Distribution Practice with broader GxP quality systems across the product life cycle. It emphasizes that not only manufacturing and testing activities (GMP, GLP, GCP) must be controlled, but also the distribution, storage, handling, and transport of products to maintain quality and traceability from producer to end user.

Definition and scope: GDPGxP seeks to ensure product integrity, patient safety, and data integrity by applying risk-based, end-to-end quality controls in the supply chain. It applies to finished medicines, active pharmaceutical ingredients, vaccines, and related medical products, including warehousing, cold chain, transportation modes, and packaging.

Key principles: A quality management system, supplier qualification, change and deviation management, documentation and record-keeping, traceability and serialization, temperature monitoring, training, audits and inspections, incident management and recall readiness, and data integrity. Implementation typically involves validated processes and robust information systems.

Regulatory context: GDPGxP is an overarching concept rather than a standalone regulation; national authorities require alignment with GDP and GxP regulations such as GMP, GLP, and GCP. Compliance is often demonstrated through quality agreements, inspection readiness, and cross-functional governance that spans manufacturing, quality assurance, logistics, and IT.

Implementation considerations: Successful adoption requires cross-functional coordination, risk-based planning, supplier qualification, validated distribution processes, and environmental controls. IT systems for batch tracing, lot-level visibility, and data integrity are central to effective GDPGxP.

Criticism and adoption: Some regulators view GDPGxP as redundant with established GDP and GxP frameworks. Adoption varies by region, product type, and organizational readiness.

See also: Good Distribution Practice, Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice, GxP.