Quotient passes FDA test of bioanalytical facility

Published: 6-Oct-2023

Conducted to audit three bioequivalence studies for three different insulin analogues,

Quotient Sciences, a global pharmaceutical drug development and manufacturing accelerator, has announced the successful completion of a US Food and Drug Administration (FDA) inspection of its bioanalytical facility in Alnwick, UK.

The regulatory inspection was conducted to audit three bioequivalence studies for three different insulin analogues for a renowned pharmaceutical company.

Quotient Sciences’ Alnwick facility has specialty bioanalytical expertise and facilities for conducting bioequivalence studies, which play a crucial role in evaluating the similarity between pharmacokinetic properties of two proprietary preparations of a formulation. 

This is an essential step in the drug development process, enabling pharmaceutical companies to demonstrate that their generic versions of a drug are therapeutically equivalent to the corresponding branded product.     

The US FDA inspection of Quotient Sciences’ Alnwick facility is a significant achievement for the organisation, highlighting its commitment to upholding the highest standards of quality and regulatory compliance. It reinforces Quotient Sciences' reputation as a trusted partner in the development of pharmaceutical drug products.

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During the inspection, the US FDA thoroughly reviewed the facilities, systems, and processes at the Alnwick site. This comprehensive evaluation included assessing adherence to Good Laboratory Practice (GLP) and ensuring compliance with regulatory guidelines. 

The US FDA authorities inspected the facility for five days, from July 24 to 28, which concluded with a findings meeting that was also attended by the head of GLP for the MHRA Quotient Sciences‘ facility successfully passed the inspection with no observations or concerns noted, demonstrating its strong quality management systems and dedication to patient safety.

The Alnwick’s site GMP facilities have previously been audited by the FDA and MHRA several times over the past 18 years, however this was the first US FDA audit that was specifically for bioanalytical work.      

Mark Egerton, CEO of Quotient Sciences, said: “By successfully completing the US FDA inspection for these studies, Quotient Sciences has achieved another milestone in its mission to support the development of innovative medicines for patients worldwide.

“The results of the inspection further strengthen our track record for outstanding regulatory compliance at our Alnwick facility. 

“At Quotient Sciences, we work diligently to maintain high quality standards and continuously improve quality platforms to ensure that we are meeting regulatory requirements that best support our global customers regulatory submissions."

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