Raw materials testing has remained comparatively less disrupted than other quality control activities.
However, describing it as “low impact” risks oversimplifying the regulatory and operational nuances that companies must still manage, explains John Welch, Associate Director of Business Operations at Butterworth Laboratories Limited.
Brexit: what’s changed?
The UK now operates outside the EU regulatory framework, with the Medicines and Healthcare products Regulatory Agency (MHRA) functioning independently from the European Medicines Agency (EMA). This has resulted in
- separate UK and EU regulatory pathways
- independent marketing authorisations
- gradual regulatory divergence (although GMP alignment remains high).
- From an EU perspective, the UK is now a “third country,” which affects activities such as batch release, Qualified Person (QP) certification and importation requirements.
Raw materials testing: a relative area of stability
Compared with finished-product testing and batch certification, raw-materials testing has been less directly affected by post-Brexit regulatory changes.
Requirements to name contract laboratories in marketing authorisations generally apply to finished-product testing, not routine raw-materials testing.
This allows greater flexibility when outsourcing testing to laboratories located outside the EU, including the UK.
The MHRA has clarified that only certain activities (stability studies and finished-product testing linked to release) must be explicitly listed on manufacturing authorisations.
This means that raw materials testing remains a comparatively flexible outsourcing activity, but it is not entirely free from regulatory oversight. Considerations still include the following:
- GMP compliance of the contract laboratory
- supplier qualification and technical agreements
- data integrity and inspection readiness.
Where challenges have emerged
Although raw materials testing itself is relatively stable, Brexit has introduced broader challenges within pharmaceutical operations.
Regulatory duplication: parallel UK and EU submissions and lifecycle management, as well as increased administrative burden and cost.
Supply chain complexity: additional customs procedures and documentation, and potential delays in the movement of materials and reference standards.
Loss of centralised systems: the UK no longer participates in EU regulatory procedures and there is greater reliance on national decision-making and evolving guidance.
Opportunities for pharmaceutical companies
Despite these challenges, it has created strategic opportunities, particularly regarding how companies structure their analytical testing models.
Outsourcing to UK Laboratories: UK-based GMP laboratories continue to offer high standards aligned with international GMP expectations, oversight by the MHRA, with globally recognised inspection credibility, and strong scientific expertise and available capacity
Operational efficiency: reduced pressure on internal QC laboratories, access to specialised analytical techniques (HPLC, GC, IC, ICP, etc.) and flexible resourcing models, including dedicated or FTE-based support.
Supply chain resilience: diversification of testing partners beyond the EU and increased agility when it comes to managing fluctuations in testing demand.
The strategic role of raw materials testing
Post-Brexit, raw materials testing has taken on greater strategic importance:
- it serves as an early control point for quality and compliance
- it mitigates the risk of downstream manufacturing failures
- it supports consistency across increasingly fragmented regulatory frameworks.
- In a more complex supply environment, this function is no longer purely operational, it is integral to risk management.
Looking ahead
Future developments will depend on the degree of continued alignment between UK and EU GMP requirements, the expansion or refinement of Mutual Recognition Agreements (MRAs), and industry adaptation to parallel regulatory systems.
One clear trend is the continued growth of outsourced analytical testing, particularly for raw materials.
Conclusion
Brexit has reshaped pharmaceutical regulation, but its impact has not been uniform. Whereas batch release and finished product testing have become more complex owing to third-country requirements, raw materials testing remains comparatively adaptable and strategically valuable.
For pharmaceutical companies, this presents a clear opportunity: to leverage qualified UK laboratories as an integrated extension of their global QC strategy while maintaining robust oversight and compliance frameworks.
