Butterworth Laboratories is proud to operate as a globally compliant pharmaceutical testing laboratory, inspected by multiple regulatory authorities, including the UK MHRA and the US FDA. Our facility and quality systems are designed to meet the highest international standards for analytical testing, traceability, and regulatory assurance.
Regulatory Inspections and Approvals
Our site is routinely inspected by the Medicines and Healthcare products Regulatory Agency (MHRA), ensuring full compliance with UK and EU GMP guidelines. In addition, we are registered with the United States Food and Drug Administration (FDA) under Facility Establishment Identifier (FEI) 3002803037. Butterworth Laboratories Limited were listed in the EudraGMDP database. However, it’s important to note that since the UK’s departure from the EU, the EudraGMDP database no longer updates entries for UK-based facilities. As a result, Butterworth Laboratories’ listing in the database reflects their compliance status as of their last inspection on 9 June 2020.
Quality Proficiency and Scheme Participation
To validate our analytical quality and accuracy, Butterworth Laboratories participates in several internationally recognised proficiency testing schemes. These include programs such as AQUACHECK run by LGC, FAPAS, and other respected third-party organisations. Consistent high performance in these schemes demonstrates our analytical reliability and data integrity.
International Standards & Commitment
Our laboratory operates with a firm commitment to continuous improvement, traceability, and regulatory alignment. Whether supporting global pharmaceutical companies or niche biotechnology firms, we maintain standards that meet or exceed the expectations of regulators across Europe, the US, and beyond. Our multi-agency approvals and participation in proficiency schemes position Butterworth Laboratories as a trusted partner for globally compliant pharmaceutical testing services
Frequently Asked Questions
The UK’s regulatory body has audited an MHRA-inspected lab to confirm that it complies with UK and EU GMP standards and other relevant pharmaceutical regulations.
Yes, we are registered with the United States FDA under FEI number 3002803037, allowing us to support US pharmaceutical companies with compliant testing services.
EudraGMDP is a publicly accessible database maintained by the European Medicines Agency, listing manufacturing and testing sites that comply with GMP standards.
They verify that our laboratory consistently delivers accurate, reproducible results by comparing performance across independent external assessments.
Yes, our quality systems are aligned with WHO expectations, further supporting our global pharmaceutical clients.
Click on the relevant tile below for further information.
