Successful FDA inspection for Quality Assistance
27th November 2019
Press release - For immediate release
Donstiennes, Belgium, 27 November 2019 - Quality Assistance S.A. successfully completed a U.S. Food and Drug Administration (FDA) inspection of its unique site in Donstiennes, Belgium. The inspection took place during September 2019 and confirms that the facility complies with the principles and guidelines of current Good Manufacturing Practices (cGMP). On 29 October 2019, the FDA notified the Contract Research Organisation (CRO) that this inspection is "closed" under 21 CFR 20.64 (d)(3).
The comprehensive inspection covered drug substance and finished product testing performed on products marketed in the United States. The FDA investigator inspected Quality Assistance’s quality system, facilities and equipment, and laboratory systems.
“We are proud of the positive outcome of the inspection which demonstrates our unwavering commitment to providing the highest quality services and generating reliable data to enable our clients to consistently market safe products,” said François Blondiau, Quality Assistance’s Compliance Director. “We commend both the individual and collective contribution of all of our employees who prepared for as well as participated in the inspection.”
Nathalie Draux, the company’s Chief Operations Officer, asserted: “Keeping up to date with the regulations applicable to the development, registration and manufacture of innovative medicinal products is at the heart of our operational processes. As a leading CRO, our clients can rely on us to consistently provide them with analytical services in compliance with the essential European and American quality standards applicable to the pharmaceutical sector: GMP, GLP, GCP/GCLP.”
Quality Assistance is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.
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