Supply Challenges and Future Technologies in 2025 An in-depth review of PDA Ireland’s landmark event held in Dublin on June 12th, 2025

The Parenteral Drug Association (PDA) Ireland Chapter’s much-anticipated 2025 Good Distribution Practice (GDP) event convened in Dublin on June 12^th, drawing professionals from across the pharmaceutical, logistics, and regulatory landscapes to tackle some of the most pressing and complex challenges facing global healthcare distribution today.

Under the theme “Good Distribution Practice – Supply Chain Challenges & Use of Future Technologies”, the event bridged complexity, compliance, and innovation in a rapidly changing world.  The day was a forum for identifying critical issues and a call for collective action, innovation, and cross-industry alignment. From Brexit-induced disruptions and inspection deficiencies to cutting-edge technologies such as artificial intelligence (AI) and blockchain, the message from regulators, manufacturers, wholesalers, distributors, and consultants alike was clear: we all share a common goal - safe and reliable supply to the patient.

GDP is more than a compliance standard in today's volatile geopolitical environment. It is a commitment to public health, global resilience, and industry integrity. However, the challenge lies with this shared purpose in a changing global landscape.

Newaj Khan, BMS Quality Unit Lead and ex-MHRA Inspector, demonstrated the consequences of Brexit, borders, and tariff challenges on driving complexity in pharmaceutical logistics. His analysis presented the post-Brexit ecosystem as a “case study in shifting from globalization to localization,” where increased regulatory divergence, customs hurdles, and non-tariff barriers have significantly strained fragile supply chains.

Key points included:

• Redundant batch testing and regulatory submissions across jurisdictions.
• Exemptions of European Union (EU) Safety features.
• Delays and increased costs due to customs declarations.
• Transport challenges with increased paperwork, new logistics arrangements, e.g. United Kingdom Hubs
• Strain on just-in-time models, exacerbating medicine shortages.

With tariffs and trade negotiations shaping distribution economics, Khan noted that “GDP and geopolitics are now inextricably linked.” His proposed mitigation strategies, such as diversifying supply chains, investing in local manufacturing, building buffer stock, and leveraging AI for predictive inventory modelling, highlighted the urgent need for adaptability and resilience.

Richard Peck, from OnAsset Intelligence, discussed “The Last Mile” distribution, emphasizing the very popular PDA Technical Report No. 46 (Revised 2024) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users. The Last Mile is the term often used to describe the transport of a product from the manufacturing facility to the end user.

Peck highlighted the inherent complexity of the pharmaceutical supply chain, which varies globally in structure and stakeholders, from manufacturers to dispensing points. He emphasized the critical need for clear responsibilities and well-designed distribution routes to maintain medicines' quality, safety, and efficacy. With a focus on last-mile delivery, the presentation explored the importance of understanding product stability and characteristics to determine suitable thermal protection. Services such as temperature-controlled logistics, robust contract management, and validated transport systems are essential for ensuring compliance with temperature-sensitive products.

Data knowledge management was underscored as vital, with static and dynamic data guiding traceability and integrity, aligned with ALCOA+ principles. Emerging technologies like AI and blockchain are reshaping how the sector ensures integrity and efficiency. Cost-effective and sustainable strategies were also stressed to prevent shortages and promote patient health. Ultimately, Peck concluded that seamless communication, training, and collaboration across all supply chain partners are crucial to safeguard product quality and ensure timely, safe patient delivery.

Health Products Regulatory Authority (HPRA) GDP inspectors Emma McCormack and Joanne Bergin's presentation, “Common GDP Inspection Deficiencies, Expectations for Addressing Them, Tips for Maintaining Compliance and Getting Through an HPRA GDP Inspection,” provided an overview of inspection findings from 2023 to 2024, illustrating how many distributors still fail to meet fundamental GDP requirements. In the two-year trend, 4 critical, 237 major, and 904 “other” citations were cited by the GDP Inspection Division of HPRA.

Key deficiencies included:

• Inadequate supplier qualification and failure to establish supplier and contractor bona fides.
• Gaps in compliance with falsified medicines regulations, e.g., failure to implement and follow procedures for verifying and decommissioning the unique identifiers on medicinal products before export, indicating inadequate supplier status verification, and a lack of documented processes to ensure legitimate sourcing from authorized entities.
• Lack of oversight of outsourced service providers and inadequate/incomplete audits.
• Poor transport validation practices and non-calibrated temperature monitoring equipment.

Their ultimate advice was to “Be brilliant at the basics.” Engagement with guidance documents, thorough root cause analysis, and solid documentation remain the backbone of compliance. Ensure there is a risk-based temperature mapping program, and all changes are documented in the quality management system (QMS). GDP inspections will only become more rigorous, and recurring deficiencies will no longer be tolerated. So, ultimately, going back to basics is not optional.  It is essential in this highly regulated world.

No conference on GDP would be complete without a discussion about the Responsible Person (RP).

Patricia Grimes of Orion GxP Consulting reminded attendees of the foundational role of the RP in upholding distribution quality and regulatory compliance. From risk mitigation to always being inspection-ready, the RP ensures that patient needs remain the focal point of every operational decision.

She urged the industry to reframe GDP not as a checklist but as a culture with strong communication, speaking of “Team Patient” and allowing everyone to understand WHY they do what they do. An RP, as Guardians of Quality, must drive a culture prioritizing safety, traceability, and ethical responsibility at every supply chain node.

In Ireland, a Qualified Persons Forum is held annually by academic institutes, bringing together regulators and qualified parties to discuss industry trends, case studies, new technologies, and more. With no formal university course to qualify as a RP, and with much to learn from each other, the need for further engagement across the industry in such forums as this event was illustrated as a strong take-home message from both regulators and attendees.

Data and digitalization continue to redefine the paradigm of all areas of the pharmaceutical industry, including the distribution sector. The event discussions underscored the critical role of advanced digital technologies in strengthening supply chain robustness, traceability, and operational agility across the sector.

Darren Crawley, Global Head of Quality at Kuehne+Nagel, presented his vision of a hyper-monitored, digitally interconnected distribution network that relies on:

• Lane Risk Assessments to identify and mitigate transit vulnerabilities.
• Cool corridors with strategic partnerships ensuring +2 to +8°C transport integrity.
• 24/7 Hypercare platforms that provide real-time monitoring and proactive escalation.

Darren emphasized that the supply chain needs to be designed to “prevent rather than cure” and that during these risk evaluations and mitigation planning assessments, if “Bad Data Goes In, Bad Data Goes Out.” This was a common theme in many presentations and is an apt reminder that data integrity and technical agreements are the backbone of reliable distribution. A weak link in this chain causes deviations that ultimately endanger patients.

Bahareh Mahmoudy, Senior Quality Manager of Amgen introduced two new innovations:

• Temperature Excursion Automation Tool, a revolutionary system developed in partnership with Carrier (a Sensitech company) that cuts excursion product impact assessments from days to minutes. This tool integrates over 10 data sources into a single record, automating release decisions and dramatically improving patient access timelines. "Once you automate and verify these calculations, there's no going back."
• SAP’s Transportation Management (TM) system was demonstrated as an end-to-end logistics solution, enabling:
• Automated freight tenders
• Real-time visibility across road, air, and sea
• Analytics for on-time delivery and cost optimization

Kane Edgeworth, Director at Biomap, delved into the critical role of vehicle qualification and cold chain integrity. His presentation illustrated the intricacies of vehicle qualification and the risks associated with poorly mapped transport systems. Using a matrix approach to qualify representative vehicles across large fleets, Kane emphasized rigorous acceptance criteria, stress testing and choosing the right test environment are all fundamental factors whilst, adherence to the World Health Organization with particular reference to Annex 5 - technical supplements to model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products (~16 Supplements)​ and EU GMP Annex 15 guidelines, qualification and validation, requirements in particular, User Requirement Specification’s and calibrations traceable to international standards. His presentation reinforced that “risk doesn’t disappear at the vehicle door. It begins there. " Without proper qualification and periodic requalification, the last mile of distribution becomes a liability.

Workshops and Fireside Chat Summary: Challenges and Solutions Through Interactive Collaboration

As part of our interactive workshops, attendees were divided into breakout groups to explore key industry topics and identify both challenges and tangible solutions. Each group appointed a scribe and speaker to report back during our collaborative sessions. The workshops were characterized by high energy, passion, and meaningful dialogue. Participants were eager to collaborate, share insights, and challenge the status quo with the overall objective of building a stronger, more resilient life sciences ecosystem.

The following is a high-level summary of the discussions and outcomes across all workshop topics:

1. Navigating Tariffs: Industry Challenges and Opportunities

This workshop explored how tariffs influence competition, supply chains, and drug availability, highlighting challenges such as geopolitical instability, recent tariff shifts, global versus site-level competition, regional imbalances in goods distribution, and limited supply chain resilience. To address these issues, proposed solutions included developing flexible site strategies that align global and local priorities, diversifying supply chains to reduce regional dependency, integrating scenario planning and geopolitical risk assessments into strategic planning, and enhancing cross-regional partnerships for more effective tariff navigation.

2. Balancing Speed and Compliance: Agility in a Regulated World

The second workshop focused on the challenge of achieving speed without compromising compliance in highly regulated industries. It highlighted the need to embrace digital transformation through AI, blockchain, and cloud technologies while maintaining strict regulatory compliance standards. The groups explored key obstacles such as limited U.S. Food and Drug Administration and global guidance on AI qualification, difficulties in validating AI for GxP versus non-GxP use, inconsistent blockchain regulations across countries, unclear data standards, and uncertainty around integrating tools like ChatGPT. Proposed solutions included defining clear internal AI policies, learning from industries with mature AI frameworks, co-developing compliant solutions with technology providers, standardizing data practices, and mapping critical data flows. The workshop also emphasized promoting AI-driven analytics to reduce bias, engaging regulators proactively to accelerate innovation, and training subject matter experts to build internal capability and ensure ongoing compliance.

3. Digital Transformation and Data Integrity: The Future of Distribution

The third workshop explored how digital transformation is reshaping pharmaceutical distribution, with a focus on enhancing efficiency, ensuring data integrity, and optimizing cold chain logistics. Technologies like AI and blockchain were discussed as key enablers in addressing the growing complexity of supply chains. Participants identified major challenges including intricate delivery requirements for batch-specific and exempt medicines, the need for real-time data to support compliant deliveries to nursing homes and pharmacies, and limited visibility across the end-to-end supply chain. Proposed solutions emphasized a holistic evaluation of cold chain needs from manufacturing to the point of care, improving information transparency for all stakeholders, tailoring logistics strategies to specific patient populations and settings, and standardizing cold chain protocols across product types and delivery destinations.

4. Cold Storage and Shipping: Mastering Temperature-Sensitive Logistics

The final workshop focused on navigating the complexities of maintaining product integrity across global cold chain logistics while balancing agility with compliance. Participants examined best practices in transport qualification, risk management, and regulatory adherence. Key challenges included securing operational buy-in for qualification processes, difficulties with risk-based supplier management, complexities in qualifying dry ice shipments and interpreting data logger outputs, unclear standards for model validation, and the burden of validating all shipping routes. To address these issues, proposed solutions included adopting a risk-based approach to shipping qualification supported by AI tools, defining clear model performance standards and qualification criteria, strengthening vendor oversight through Key Performance Indicators and Quality Technical Agreements, reinforcing internal audits with robust self-assessment, and ensuring complete documentation as part of wholesale distribution compliance. The workshop also emphasized the importance of fostering a culture where agility is enabled by strong compliance frameworks and continuous evaluation.

The Health Products Regulatory Authority (HPRA) carefully listened to the outputs of the workshops. They acknowledged the growing complexity of GDP due to evolving supply chain structures and challenges. In response, the HPRA offered the following support and guidance:

• Expressed openness to establishing a Responsible Forum for GDP, encouraging ongoing industry collaboration.
• Confirmed their willingness to support training to RPs to enhance compliance understanding and operational application.
• Highlighted the importance of risk-based approaches and strongly emphasized the availability of the International Conference on Harmonization (ICH) Q9: Quality Risk Management training materials, currently accessible on the ICH website.

Their engagement reinforced the value of proactive, collaborative dialogue between regulators and industry to drive innovation while maintaining compliance standards.

Conclusion: A Call to Action

The overarching takeaway from the 2025 PDA Ireland GDP Conference was a reaffirmation that the industry must re-anchor itself in the core elements of GDP. This includes prioritizing a robust QMS, rigorous supplier and vehicle qualifications, and uncompromising data integrity, all while embracing innovation that is both transformative and compliant.

Far more than a technical forum, the event served as a unified call to action, emphasizing the necessity for deeper collaboration between industry stakeholders and regulatory bodies. As geopolitical volatility, climate challenges, and global health risks intensify, GDP must be regarded not as a singular obligation but as a foundational pillar of equal healthcare access and sustained patient trust.