Quay Pharma achieves successful US FDA inspection

Underlining the company’s ability to support development projects on a worldwide basis from pre-formulation to initial commercial manufacture

Quay Pharma FDA audit confirms that the company's systems are compliant with GMP

UK pharmaceutical outsourcing firm Quay Pharma has cemented its capabilities as a global partner for drug development projects following a successful pre-qualification inspection of its laboratories by the US Food and Drug Administration (FDA).

The audit confirms that the Deeside company's 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 firm says the successful FDA inspection underlines its 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 of Quay’s operations through the continuous improvement of its comprehensive Quality Management Systems.

'We are delighted at this latest endorsement of our capabilities,' said 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.'

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