Good distribution practice (GDP) inspections are throwing up some common deficiencies, according to inspectors. This insight was shared during a one-day session that explored supply chain challenges, regulatory perspectives, and digital innovation.
The event, in Ireland on 12 June 2025, began with a welcome from the PDA, followed by a thought-provoking presentation on post-Brexit supply chain challenges, particularly the impact of new tariffs and divergence on pharmaceutical distribution and regulated processes. An overview of the updated PDA Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users i offers practical tools for maintaining product integrity to the end user.
Insightful presentations from industry speakers addressed the complexity of the supply chain and emerging technologies. The event offered valuable guidance for maintaining compliance and resilience in an evolving pharmaceutical landscape.
A highlight from the meeting was the keynote address by two inspectors from the Health Products Regulatory Authority (HPRA), who shared some of the issues they encounter, expectations for addressing them, and tips for maintaining compliance. The presentation provided key guidance based on a review of deficiencies from 2023 to 2024 ii.
After inspections of approximately 252 sites, the inspectors noted that they had given four critical deficiencies relating to the quality management system which encompassed most or all of the GDP chapters. Major deficiencies were higher in the areas of operations, outsourced activities, and transportation.
- Critical – Quality Management System (4)
- Major – Chapter 5 Operations (48)
- Major – Chapter 7 – Outsourced Activities (39)
- Major – Chapter 9 – Transportation (30)
The inspectors indicated that common gaps include inadequate qualification and periodic verification of customers and suppliers. The inspectors emphasized the importance of maintaining clear and well documented onboarding processes for new suppliers. They highlighted that industry should ensure that audit programs align with the scope of the services and noted that robust, ongoing oversight throughout the business relationship is key in supporting ongoing GDP.
Comprehensive transportation validation remains an essential expectation, ensuring that equipment is also properly qualified, and that the validation process should reflect the actual supply model, including transit routes, associated risks and change control procedures. The inspectors pointed out that validation studies must consider all relevant components, with decisions justified by data and be clearly documented within the quality system.
To maintain compliance, delegates were reminded not to overlook the fundamentals. Staff should not only be trained in GDP principles but also understand how to apply them practically. Rather than overcomplicating processes, organizations are encouraged to share good practices, make use of available resources, and build on proven frameworks. The inspectors advised organizations to carry out effective risk assessments utilizing principles in ICHQ9 iii and to look beyond the immediate issue to identify potential wider impacts which help to avoid repeat deficiencies during inspections. Ultimately, being prepared, ensuring clarity, and a willingness to seek guidance are essential to building a sustainable and inspection-ready GDP compliance culture.
Further presentations explored the critical role of the Responsible Person (RP) as a “Guardian of Quality” iv within the distribution network, reinforcing the RP’s importance in ensuring compliance and patient safety. Sessions on innovation and artificial intelligence (AI) demonstrated how technology is transforming supply chain risk mitigation, particularly through lane risk assessments to determine issues with a particular transportation route, and automated temperature excursion reviews. Presenters noted that a review of vehicle qualification and fleet validation requirements were also important to highlight evolving expectations in transportation compliance.
Interactive workshops were also held to enable the audience to tackle key distribution challenges. These sessions covered a wide range of topics including navigating tariff complexity, aligning speed and compliance, enabling digital transformation without compromising data integrity, and cold storage and shipping for temperature sensitive products. The themes emphasised the growing complexity of global supply chains, the need for continual regulatory awareness, the strategic value of digital tools, and improving process efficiency, reducing human error and mastering temperature sensitive logistics in a dynamic and highly regulated environment.
Throughout the event there was an emphasis on the importance of ongoing collaboration and open dialogue between industry and the regulators. There was clear enthusiasm for continued forums focusing on GDP compliance, the evolving role of the responsible person, and practical challenges in distribution, with attendees advocating for regular stakeholder meetings to foster transparency and proactive enlightenment. The HPRA acknowledged the increasing complexity of GDP compliance driven by global supply chains and diverse business models, and expressed openness for deeper engagement. Notably they committed to supporting the industry with more tailored guidance, especially on the application of quality risk management.
Summary
The event highlighted the importance of collaboration, regulatory awareness, and digital innovation in maintaining a resilient pharmaceutical supply chain. By excelling at GDP basics and embracing innovation, the pharmaceutical industry can more readily achieve compliance and resilience in the face of evolving challenges.
About the author:
Deborah Harrison acts as a Responsible Person (RP) and Responsible Person Import (RPi) on Wholesale Dealers Authorisations (UK) within PharmaLex’s quality and compliance commercialization readiness team. She has more than 14 years of experience in pharmaceutical supply chain management with a strong foundation in both GMP and GDP compliance. Her expertise covers the end-to-end storage and distribution of medicinal products including temperature sensitive medicines and narcotics.
i PDA Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users
ii Common GDP Inspection Deficiencies, Expectations for Addressing Them, Tips for Maintaining Compliance & Getting Through a HPRA GDP Inspection Presentation (Emma McCormack & Joanne Bergin)
iii https://www.ich.org/page/quality-guidelines
iv PDA Ireland Good Distribution Practice – Supply Chain Challenges and Use of Future Technologies Agenda
