qp2016.003 FDA InspectionQuay Pharma has cemented its capabilities as a global partner for drug development projects with the announcement that its laboratories and manufacturing facilities have completed a successful prequalification inspection by the US Food and Drug Administration (FDA).

The audit confirms that the Quay systems are compliant with the principles and guidelines of Good Manufacturing Practice (GMP) and no deficiencies were identified.

Combined with Quay’s recent £3 million investment in GMP manufacturing suites and the granting of a Commercial Licence by the MHRA, the successful FDA inspection underlines the company’s ability to support development projects on a worldwide basis from pre-formulation through clinical trials and up to initial commercial manufacture.

It also demonstrates the high levels of regulatory compliance in all Quay’s operations through the continuous improvement of its comprehensive Quality Management Systems.

“We are delighted at this latest endorsement of our capabilities,” comments Quay CEO Maireadh Pedersen. “We will continue to invest in facilities, people and equipment to support our growth and further strengthen our reputation as one of the most innovative and responsive formulation development companies.”