5 Top Tips for Addressing Current GDP Compliance Challenges
Article By Michelle Yeomans, EPiC Operations Manager
At EPiC’s GMDP symposium in November 2025, Tony Orme, ex MHRA Expert GDP Inspector and EPiC Consultant shared his thoughts on what companies can and should be doing to assess the current reality with respect to GDP compliance in their organisation. Drawing from the knowledge shared by Tony during his insightful GDP Master Class.
Drawing from the knowledge shared by Tony during his insightful GDP Master Class, here are EPic’s Top Five Tips for addressing current GDP compliance challenges:
Best Practices to Strengthen GDP Compliance
1. Preventing Theft of Medicines Through Stronger GDP Security Controls
Analysis of medicine theft data obtained from MHRA for the years 2023, 2024 and up to June 2025 confirms that the majority of medicines were stolen as a result of theft from motor vehicles. Help to reduce the risk by ensuring that provisions for security of vehicles are considered as part of the criteria for selecting transport providers and try to plan deliveries to warehouses to ensure timings allow limited waiting time outside secure compounds, as most thefts occur while vehicles are parked up waiting to deliver products.
2. Reducing Criminal Diversion Risks with Robust Customer Qualification
Criminals are actively probing for weaknesses in the medicines supply chain including using fake company profiles to pose as legitimate companies to obtain medicines. Reduce the risk of being duped by criminals by implementing robust checks and approval of new customers and requests to change customer profiles.
All available evidence should be used to qualify a new customer rather than taking information on trust. The process should involve a critical review of information rather than a check list approach and be mindful of attempts to divert attention to fake website profiles. The RP should have final sign off when setting up new customers, and QA should maintain oversight of what is being ordered and any requests to change the customer profile following the initial approval.
3. Managing Internal Threats to Protect the Medicines Supply Chain
It is not just criminal gangs who are pretending to be legitimate companies to obtain medicines by diversion tactics, the GPhC have issued warnings to raise awareness of the diversion of medicines from pharmacies where medicines have been ordered and stolen by members of staff. Help to mitigate the risk by recognising the threat posed by staff within your organisation and strengthen recruitment procedures by ensuring reference checks are undertaken, CRB checks are incorporated, and implement random security searches of staff as they exit the site.
4. Improving Transportation of Medicines Through Temperature Control and Oversight
Transportation remains in the top 5 of the most cited Major GDP deficiency category resulting from MHRA GDP inspections. Considering the summer of 2025 was the warmest on record for the UK, ensure that all transport data has been reviewed to identify any temperature excursions and ensure effective CAPA has been implemented. Use the information to be proactive when planning distribution in higher temperatures and be prepared to alter delivery plans if necessary.
It’s important to know how products are transported and the performance capability of temperature controlled fleets. Regularly seek positive confirmation that correct temperatures are maintained especially for complex or long journeys, rather than relying on negative reporting of deviations by the transporter.
5. Using Self-Inspection to Strengthen GDP Compliance and Inspection Readiness
Improve the effectiveness of your self-inspection process by ensuring that current “hot topics” such as theft, diversion, and transportation of medicines are include as areas of focus in the self-inspection programme. Prioritise Customer Qualification as a high-risk area and perform a deep-dive focused audit of the process to ensure you have implemented effective safeguards to protect you from supplying medicines to an unauthorised entity, as this could result in a critical deficiency if identified during an MHRA GDP inspection.
Conclusion & Key Takeaway
Good Distribution Practice (GDP) is not just about meeting regulatory compliance expectations; it is about protecting patients by maintaining the quality, integrity, and security of medicines throughout the supply chain.
By focusing on high-risk areas such as theft of medicines, criminal diversion, customer qualification, and the transportation of medicines, organisations can improve the effectiveness and build a more resilient Pharmaceutical Quality System (PQS) to withstand the threats posed by opportunists and environmental factors and be better prepared for future MHRA GDP inspections.
Continue the Conversation at EPiC’s Half-Day GDP Symposium – Strengthening GDP Compliance Through Insight, Action & Leadership
To explore these topics in greater depth, join EPiC for our upcoming half-day Good Distribution Practice (GDP) Symposium on Tuesday 10th November 2026.
Designed to support pharmaceutical professionals in navigating today’s evolving GDP landscape with confidence and clarity, the symposium brings together expert insight from experienced practitioners and former MHRA inspectors. The programme combines regulatory updates with practical, real-world guidance across several critical GDP topics, including current regulatory “hot topics”, management of controlled drugs, proportionate qualification of equipment and facilities, upcoming changes affecting fiscal importation, and key considerations for GDP audits and Responsible Person oversight.
Structured to move from awareness and compliance fundamentals through to practical application and leadership influence, the symposium will conclude with an expert panel Q&A, giving delegates the opportunity to raise real-world questions and gain thoughtful, constructive guidance.
Reserve your place today to strengthen your GDP knowledge, prepare for emerging regulatory expectations, and take practical insights back to your organisation.
Need support with GDP compliance? If you want to strengthen your approach to regulatory compliance, reduce the risk of medicine theft, or review your transportation of medicines processes, EPiC can help. Our experienced GDP consultants can support you with gap assessments, self-inspection readiness, customer qualification reviews, and practical improvements to help protect your supply chain.
Contact EPiC today to discuss how our GDP consultancy services can help your organisation prepare for future GDP challenges. Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com