Test Labs Achieves GLP Certification: A New Milestone in Quality and Excellence

Test Labs Achieves GLP Certification

We are thrilled to announce that Test Labs has achieved Good Laboratory Practice (GLP) certification, marking a significant milestone in our dedication to quality, integrity, and excellence. This certification is a testament to our dedication to maintaining the highest standards for non-clinical safety studies performed in the laboratory, ensuring that our processes and data meet rigorous regulatory requirements.

At Test Labs, our commitment to quality has always been foundational. Our entire laboratory is built on robust quality management systems. We have always approached certifications and accreditations pragmatically, dedicating time and resources to systems that genuinely add value for our customers. Achieving GLP certification is no exception. We identified GLP as a prerequisite and essential requirement to support the medical device industry, especially for clients seeking FDA approvals.

In 2023, we engaged with the Medicines & Healthcare products Regulatory Agency (MHRA) to establish a roadmap for successful certification. Toni Carlton, our Head of Quality and Compliance, led this project. Having successfully achieved ISO 17025 accreditations and maintaining multiple quality systems at Test Labs, Toni brought tremendous focus and expertise to this endeavour. Supported by Enrico Allegra, our Head of Laboratory, Toni worked tirelessly to achieve full compliance with GLP in a remarkably short period.

Test Labs UK GLP test types: Physical/Chemical Testing, Other, In-Vitro Safety Testing, Biocompatibility, Medical Device Testing.

What This Means for Our Clients

Receiving GLP certification means we can assure our clients that they will have access to a test facility capable of producing high-quality, reliable, and reproducible data that meets regulatory standards. This certification, along with the other accreditations already achieved at Test Labs, reinforces our commitment to continuous improvement of our Test Facility management system. We are dedicated to delivering results that withstand the highest scrutiny.

As Enrico Allegra remarked, “This achievement is a testament to our determination to ensure full compliance with GLP guidelines and reflects our continued confidence in our quality systems.”

As we see a global increase in medical device reprocessing validation enquiries, along with the need for biocompatibility studies, we will be able to offer all these testing services as GLP studies.

Enrico Allegra: “This achievement is a testament to our determination to ensure full compliance with GLP guidelines and reflects our continued confidence in our quality systems.”

A Message from Our Head of Quality and Compliance

Toni Carlton expressed her enthusiasm, stating, “Receiving GLP certification from the MHRA is a major milestone for Test Labs. It signifies our unwavering commitment to excellence, facilitating globally compliant products onto the market, and our dedication to providing reliable and reproducible data.”

We have enjoyed working with the MHRA and felt that both parties kept the momentum. The process was clear, diligent, and fast-paced, which allowed us to achieve this certification in a relatively short amount of time. The team at the MHRA were very professional, and we have enjoyed the experience.

Toni Carlton: “Receiving GLP certification from the MHRA is a major milestone for Test Labs. It signifies our unwavering commitment to excellence, facilitating globally compliant products onto the market, and our dedication to providing reliable and reproducible data.”

Looking Ahead

Achieving GLP certification is a proud moment for Test Labs, but it is also just the beginning. We are committed to maintaining and continuously improving our standards to stay at the forefront of the industry. As we move forward, we will continue to prioritise quality, integrity, and excellence in everything we do.

Marianne Browning, our Business Development Manager, highlights the broader impact: “Our GLP certification opens up new opportunities for collaboration and market expansion, making us an even more valuable partner in your success.”

As we speak with people working in the industry, we listen to their challenges, problems, and jobs to be done. We want to ensure that each study completed for regulatory submissions is rock solid and meets the requirements of the regulators globally.

Our Commitment to You

At Test Labs, we believe in a consultative testing approach and have a keen interest in seeing our customers’ products succeed in the market. We measure our relevance by our customers’ success, creating value through strong partnerships and a deep understanding of their needs. Our state-of-the-art facilities and expert team enable us to offer a focused range of testing solutions that help manufacturers meet regulatory requirements and bring safe and effective medical devices to market.

We would like to extend our gratitude to our dedicated team, whose hard work and commitment made this achievement possible. We also thank our clients and partners for their continued trust and support. Stay tuned for more updates and exciting developments from Test Labs.

Contact Us:

020 3813 0969 info@testlabsuk.com

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Written by Tautvydas Karitonas July 25th 2024

Tautvydas Karitonas is an experienced professional with a decade of involvement in developing cutting-edge healthcare products that are now widely used in hospitals globally. He presently serves as the Managing Director at Test Labs, a Medical Device Contract Research Organization dedicated to accelerating access to market for medical devices. Adept at balancing technical expertise, strategic vision, and the ability to inspire others, his leadership is defined by a distinctive blend of proficiency, strategic thinking, and effective guidance.

Tautvydas holds BSc and MSc degrees in Mechanical Engineering, which provides him with a distinctive approach that links product design and development process with device verification and validation. He has used his experience in developing hydrogen peroxide and UV-C light technologies to influence the laboratory design and expedite research timelines. Tautvydas is proud of leading the Test Labs team in achieving a prestigious UKAS accreditation in under 12 months.

Tautvydas is an expert in product development, validation, and problem-solving, making him a valuable member of any team he works with. He shares his knowledge and passion for the industry through his posts, where he discusses a range of topics from the latest medical device regulations to the impact of emerging technologies on the healthcare industry.