Therapure Biopharma has announced that it has received a compliant rating from the Health Products and Food Branch Inspectorate of Health Canada.
The rating results from a Good Manufacturing Practices (GMP) inspection conducted at Therapure’s facility during November 2011. The compliant rating means that the Company has successfully demonstrated that the aseptic fill/finish activities conducted in the facility as well as the associated support services are in compliance with the high standards of the Canadian Food and Drugs Act and its associated regulations.
This detailed inspection covered Therapure’s vial, syringe and preformed bag filling capabilities. Based on the results of the inspection, Therapure maintains its Establishment License and retains its ability to manufacture commercial products for existing and new clients in Canada and Europe.
"The completion of the Health Canada inspection and the issuance of a compliant rating is confirmation of Therapure Biopharma’s ongoing commitment to maintaining quality systems to the highest global standard," said Nick Green. "In addition to being recognized in Canada, under the terms of the Mutual Recognition Agreement between Canada and the European Community and Australia, this Establishment License will be recognized by the European Medicines Agency (the EMA) and the Australian Therapeutic Goods Administration.
"Quality is a cornerstone on which we build our business. As a company we strive to provide consistent performance, which is the key to maintaining the safety and effectiveness of every product that is manufactured resulting in the quality and reliability that is expected of a biologics manufacturing organization."
As a result of achieving the compliant rating, Therapure will continue to provide formulation, filling, packaging, and testing services for approved biotherapeutic, prescription pharmaceutical, and plasma-derived biological products meeting the manufacturing outsourcing needs of the pharmaceutical and biotechnology industry.