Good Distribution Practice (GDP)

Also see: The key components of GxP compliance

What is Good Distribution Practice (GDP)?

Good Distribution Practice (GDP) is a quality system that governs the distribution of medicinal products for human use. It ensures that medicines are consistently stored, transported, and handled under suitable conditions, as required by regulators such as the European Medicines Agency (EMA) and the World Health Organization (WHO).

GDP matters because distribution gaps can degrade medicines, lead to recalls, or result in regulatory action. For pharmaceutical logistics professionals, GDP compliance is a license to operate, not a choice.

Also read: 7 GDP requiements for pharmaceutical warehouses

Who is responsible for GDP compliance?

GDP responsibility spans roles across manufacturing, warehouses, and logistics. Accountability lies with the Responsible Person (RP), while execution falls on QA, validation teams, and facility operators.

Typical GDP roles include:

• Responsible Person (RP): Owns the GDP quality system and approves subcontracted activities.
• QA or validation manager: Designs protocols for mapping, monitoring, and calibration.
• Facility manager: Executes protocols on-site, balancing operations with compliance.
• Logistics providers: Must prove transport conditions are qualified and documented.

Example: A logistics hub in Germany mapped its storage zones before opening, placed data loggers at hot and cold spots, and had the RP sign off on the results—an approach inspectors consistently endorse. This reduced requalification costs and demonstrated a strong link between mapping and monitoring.

Also read: GDP temperature mapping: Protocol template, re-mapping frequency, and acceptance criteria

What are the key principles of GDP?

GDP principles are anchored in EU GDP guidelines (2013/C 343/01) and WHO TRS 961 Annex 9. They ensure products stay within safe conditions across the supply chain. Each principle reflects a compliance and operational safeguard that inspectors consistently check.

GDP requires that products are consistently protected during storage and transit, with environments mapped before use to identify hot and cold spots. All monitoring devices must be calibrated and traceable to ISO 17025 standards. Deviations such as excursions must be documented, investigated, and resolved, while records remain audit-ready, accurate, and retrievable. Staff must be trained so that procedures are followed consistently across operations. USP <1079> adds guidance for storage and shipping practices, including the use of Mean Kinetic Temperature (MKT) for excursion evaluation.

Real-world example: During an MHRA inspection in the UK, a warehouse avoided a critical observation by presenting a complete deviation log linked to CAPA records, showing timely resolution of repeated alarms.

Also read: Guide: GDP monitoring requirements

What does GDP require for temperature mapping?

GDP requires temperature mapping of a warehouse or transport unit before use, under representative conditions. Mapping identifies airflow, temperature variation, and seasonal risks. Inspectors expect clear justification for logger numbers, placement, and requalification triggers.

GDP mapping expectations:

• Initial mapping: Required before use under representative conditions.
• Risk-based placement: Sensors must be positioned to capture worst-case conditions.
• Re-mapping triggers: Layout changes, HVAC modifications, seasonal shifts, or excursions require requalification.

WHO TRS 961 and ISPE Good Practice Guide (2nd ed.) emphasize risk-based requalification. A robust initial study reduces the need for repeat mappings. For example, one semi-big pharma reduced downtime across multiple sites by adopting a standardized mapping grid and defining seasonal triggers in advance.

Also read: Continuous mapping for GDP: How it works

How does GDP apply to transport operations?

GDP extends beyond storage. It requires temperature control during transport and documented handovers across the supply chain. IATA CEIV and ISO 21973 provide aligned frameworks. Inspectors often request documented evidence of route qualification and handover responsibilities.

Transport-related GDP requirements:

• Qualify routes: Perform lane qualification for road, sea, and air.
• Use validated containers: Equip shipments with qualified packaging and loggers.
• Ensure documented handovers: Capture responsibilities during transitions.
• Manage excursions: Document investigation and CAPA for any out-of-spec event.

Example: A gene therapy shipment in a qualified ULD container was mapped before first use. Continuous monitoring verified conditions throughout transport, satisfying both GDP and CEIV requirements. This proactive qualification avoided costly delays and ensured release on arrival.

Also read: GDP transport: CEIV requirements for pharmaceutical logistics

What are the GDP requirements for documentation and audits?

Auditors expect complete traceability across mapping, monitoring, and calibration. Annex 11 and 21 CFR Part 11 apply to digital records, making data integrity a central focus. Companies that rely on manual systems often struggle with missing calibration certificates or inaccessible deviation logs – both common audit findings.

GDP documentation must cover:

• Protocols and reports: Approved and archived for mapping and monitoring.
• Calibration certificates: Traceable to devices and linked to specific locations.
• Deviation records: Investigations and CAPA tied to excursions.
• Training logs: Proof of competence for GDP tasks.

Real-world example: A logistics provider in the Netherlands avoided a major GDP observation by implementing a digital calibration record system that linked device IDs directly to monitoring locations. This allowed inspectors to retrieve certificates in minutes rather than hours.

Also read: GDP monitoring requirements guide

References and regulatory sources

• European Commission. Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01). Read here
• World Health Organization. WHO Technical Report Series No. 961, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products. Read here
• United States Pharmacopeia. USP <1079> series: Good storage and shipping practices. Read here
• ISPE. Good Practice Guide: Controlled Temperature Chambers (2nd edition, 2021). Read here
• IATA. Temperature Control Regulations (TCR) and CEIV Pharma program. Read here