Health Canada: Successful inspections for Héma-Québec
Montréal, June 8, 2010 — Héma-Québec has passed Health Canada’s annual inspection of its facilities and, consequently, her establishment license is maintained. The yearly audit took place between October 5-16 for Montréal and between November 30 and December 4th for Québec City.
Inspection of the Centre Laval and Laurier Québec Globule Blood Donor Centres took place simultaneously. Health Canada has therefore renewed their respective Licence.
The observations made by Health Canada’s inspectors deal primarily with improving compliance with Good Manufacturing Practices (GMP). Therefore, nine observations without any major direct effect on product safety were issued for the Montréal facilities and only one for the Québec facilities. As for the Globule Blood Donor Centres, none were issued for the Centre Laval Globule and only one for Laurier Québec Globule. Corrective measures have already been or will soon be implemented.
"Maintaining the establishment licences states that Héma-Québec has fully integrated Health Canada’s standards and confirms that she provide optimal quality blood components to Québec’s population. These satisfying audits are also a testimony of our staff's professionalism”, said Dr. Francine Décary, President and Chief Executive Officer of Héma-Québec.
These audits are designed to ensure compliance with safety measures and with the requirements stipulated in its operating licence. Health Canada representatives inspect Héma-Québec’s Montréal and Québec facilities every year, and closely examine the three Globule Blood Donor Centres every two years.
About Héma-Québec
Héma-Québec's mission is to efficiently provide adequate quantities of safe, optimal blood components, substitutes, human tissues and cord blood to meet the needs of all Quebecers; to provide and develop expertise along with specialized and innovative services and products in the fields of transfusion medicine and human tissue transplantation.
Give blood. Give life.
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Responses to observations stemming from the Health Canada
inspection of the Montreal facility
Response to the observation stemming from the Health Canada
inspection of the Québec facility
For more information:
Héma-Québec
Media line | 514-832-0871