Good Distribution Practice

Introduction 

There have been considerable changes to Good Distribution Practice (GDP) requirements over the last 5 years, in part influenced by the continuing effects of Brexit, and the lasting impact caused by the COVID pandemic. The changes have complicated regulatory requirements which have ultimately, impacted hiring needs and the broader quality assurance labour market within the UK.

To gain a balanced overview of the current state of the GDP market, I drew on the insights of quality professionals within the area to underline some established and emerging trends that look set to shape UK regulations for years to come. Participants from a variety of business models were chosen to ensure accurate representation, ranging from small wholesale distributors to consultancies and larger virtual pharmaceutical organisations.

Contents:

1. Regulatory Updates
2. Current Trends
3. Looking Ahead
4. Conclusion

1. Regulatory Updates

A key evolution in GDP regulations post-Brexit has centred on the increased procedures and ultimately cost needed to import products from the EU. This added complexity has mainly been caused by increased customs paperwork which has heightened the burden on quality personnel, leading to an increased demand for GDP headcount in the market. Crucially, this has also had a considerable impact on trade with Northern Ireland due to the continued uncertainty and cost-time implication causing some businesses to re-assess whether it is viable to continue supplying medicines to this region. It has been a learning experience for all, with initial guidance coming slower than anticipated which has impacted adequate planning, but there needs to be a greater focus on how these changes impact the patient end-user.

The MHRA have introduced the Responsible Person for Import (RPi) role to avoid forcing WDA holders to obtain an MIA to gain products from the EU which has added to regulatory complexity. As the RPi appointment deadline passed at the start of 2023, there still seems to be some confusion around the requirements for a successful application. Specifically, there seems to be some disconnect regarding the continued need for a scientific degree requirement and paid professional body membership for professionals with extensive relevant work experience. Given the novel nature of the process, it is understandable that providing a uniform process and formal timescale may be challenging, however, it is vital for ensuring acceptable quality standards.

Ultimately, the role of GDP Quality Personnel has become increasingly complicated, driven by changes in MHRA enforcement strategy encompassing a range of short-notice inspections and surveillance programmes. As such GDP quality professionals have needed to adapt to changing regulations to identify and overcome potential inadequacies in quality processes. This increased complexity, has fuelled rising demand and competition in GDP quality recruitment.

2. Current Trends

Following the MHRA deficiency report earlier this year, GDP professionals continue to struggle with the same underlying factors.

A frequent point of contestation given by many RPs continues to revolve around the level of QMS oversight, which often falls to a different person within the quality team if employed in more of a technical function.

Transport has continued to cause issues with vast inconsistencies between wholesalers depending on inspection completion, meaning those pending inspection could enjoy cheaper costs and price services more competitively.

As wholesale trade volumes have dropped significantly post-Brexit, there has been rapid growth in outsourced activities which require proper qualification processes. 

3. Looking Ahead

A key emerging trend highlighted across the GDP area has focused on temperature monitoring which has been exacerbated by the growing impacts of climate change. With the increasing complexity of pharmaceutical products, maintaining temperature control throughout the supply chain has never been more crucial. This has been highlighted by the widespread use of advanced temperature-monitoring technologies and cold chain logistics to prevent excursions and maintain product efficacy. The importance of this was highlighted last summer as legacy temperature control systems struggled to handle the abnormally high temperatures. Warehouses readily exceeded the 25°C mark which posed a huge risk for many UK-licensed products that are typically labelled as “store below 25°C”. Extreme temperatures are expected to become increasingly prevalent, requiring the need for a robust risk-based approach to be further implemented.

Any risk-based model should prioritise validation as a pivotal step in ensuring applicable quality standards. Adequate transport validation will allow companies to route risk assess and determine whether temperature controls are the most cost-effective measure depending on the season. This is an issue that the industry needs to tackle collaboratively with greater regulation and utilisation of new innovations and technologies such as AI and ML. This will push a “real-time” regulatory management process allowing live performance data sharing from patients through to regulators across borders and time zones. While this will improve the monitoring of temperature compliance, it will also provide a long-term opportunity for cost-saving among wholesalers.

Initiatives such as carbon credits are useful tools to offset some rising wholesaler costs along with rewarding progressive steps to net zero. These credits are already used in a multi-faceted tender process run by the NHS when awarding contracts. Ultimately, a balanced approach needs to be adopted to ensure modernisation of distribution practices does not lead to a reduction in wholesale distributors operating in the UK market. 

The recent changes to the GDP environment provide an opportunity for innovation despite ongoing challenges to hiring and quality structure. This has hit the regulator first-hand with lots of changes to MHRA inspectorates as established personnel look to either transition into industry or take the consultancy route. Time will tell how these alterations will impact the focus or structure of inspections, but there will be a period of adjustment for all parties involved. During this period, it is important to pursue closer collaboration with other regulatory markets on activities such as the Falsified Medicines Directive and Barcoding to streamline and de-mystify novel quality procedures. A key area of focus will undoubtedly centre on data sharing both internally and externally to allow for a more in-depth analysis of standards which will promote a proactive quality approach. 

4. Conclusion

With the increased complexity of regulations, Walker Cole has successfully completed mandates across retained, contingent, and consultancy solutions in the GDP quality area. This has allowed us to have first-hand oversight of the difficulties businesses are facing in the current market. 

For anyone with follow-up questions or interested in having a further discussion on this, please feel free to contact me for a confidential conversation at either:

George Kapanadze Recruitment Consultant at Walker Cole International E: gk@walkercole.com M: +44 02081035476

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