CTMF EXTERNAL LABORATORY TESTING WFI & PURE STEAM

he National Research Council of Canada is building a new Clinical Trial Manufacturing Facility (CTMF) that will house the process and equipment for the production and the quality control of protein, viral vector or virus-like particle vaccines or biologics. The products are mainly intended for the Canadian market, regulated by Health Canada under the authority of the Food and Drugs Act. The facility will require being compliant with Canadian Good Manufacturing Practices (GMP) as well as FDA current GMP (cGMP) and Eudralex requirements.

The Water for Injection and Pure steam generation and distribution loop must be monitored. To do so, a certain number of samples needs to be tested in order to meet the regulation expectations, including the following types; I. WFI II. Pure Steam III. Other (pre-treatment/city water)