Ireland HPRA’s Guide: Good Distribution Practice (GDP) of Medicinal Products

The Health Products Regulatory Authority (HPRA) of Ireland released Version 8 of its Guide to Good Distribution Practice (GDP) in March 2024. This updated guide, "Good Distribution Practice of Medicinal Products for Human Use" on 8th April 2025 outlines how companies should store, transport, and distribute medicinal products safely and securely across the supply chain. It is aligned with EU GDP guidelines (2013/C 343/01) and ensures that only quality-assured medicines reach patients. This latest edition of the GDP guide introduces a deeper focus on data integrity, digitally enabled monitoring, and managing third-party risks.

GDP is a critical framework ensuring the quality and integrity of medicinal products throughout the supply chain. By adhering to GDP guidelines, wholesalers, distributors, and brokers mitigate risks of contamination, counterfeiting, and regulatory non-compliance.

‘Sale by wholesale’ means sale or supply for sale, in the course of a business or for administration to patients in the course of a professional practice. Wholesale distribution includes all activities consisting of procuring, holding, supplying or exporting medicinal products, other than activities involving the sale or supply of such products to the public.

Building a Culture of Quality: Systems and People

Companies are expected to create a structured framework encompassing all distribution activities, backed by documented procedures, change control, internal audits, and root-cause driven corrective and preventive actions (CAPAs). Importantly, Quality Risk Management (QRM) must be embedded in day-to-day operations, allowing teams to proactively identify, evaluate, and control distribution risks.

At the heart of every compliant operation stands the Responsible Person (RP). From overseeing internal audits to managing recalls and regulatory communications, the RP must always be accessible and deeply familiar with GDP principles.

Facilities, Transport, and the Science of Safe Movement

Medicinal products must be stored in environments that preserve their quality. That means clean, pest-free warehouses with validated temperature and humidity controls, proper segregation of goods, and real-time monitoring.

When it comes to transporting medicines, companies must ensure that transit conditions do not compromise product integrity. Transport must be secure, temperature-controlled where needed, and monitored to prevent excursions. Whether using company-owned fleets or third-party logistics partners, it's essential to validate delivery routes and storage durations. Chain-of-custody must be documented at every handoff to ensure full traceability.

Documentation: If It’s Not Written Down, It Didn’t Happen

Documentation continues to be a cornerstone of GDP compliance. Every activity—from incoming deliveries to complaints, temperature logs to recall communications—must be documented and retained for at least five years.

Handling the Unexpected: Returns, Recalls, and Complaints

The updated guidance places particular emphasis on how companies manage complaints and product returns. Medicines that are returned must not be automatically placed back into saleable stock. Instead, they require proper quarantine, assessment, and documentation. For recalls, companies must have a rapid, well-practiced process in place, with roles clearly defined and communication pathways open. Importantly, the HPRA must be informed when public health may be affected.

Cold Chain Considerations: Precision is Everything

For temperature-sensitive products, the guide highlights the criticality of cold chain management. These products must be stored and transported in validated shipping containers with continuous temperature monitoring. Any deviation must trigger an immediate investigation, with full traceability of affected batches. Cold chain failures are not just operational hiccups—they can render life-saving medicines ineffective.

Outsourcing Doesn’t Mean Outsourcing Responsibility

Outsourcing transport or storage does not absolve a company from compliance. All third-party providers must be audited and approved, with responsibilities clearly outlined in technical agreements. The guide reinforces that the marketing authorization holder or wholesaler retains ultimate accountability, regardless of who physically handles the product.

It recognizes the changing landscape of pharmaceutical logistics, where automation, remote temperature tracking, and digital audits are becoming the norm. The HPRA also raises its expectations around self-inspections, encouraging companies to proactively identify non-compliance before regulators do.

For further information and to access the full guidance document, download the Guide (PDF).