Health Canada has issued a Draft Guidance Document: Disinfectant Drugs (2013).
The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms
According to Health Canada:
"This document has been created to provide a more user friendly and comprehensive overview of the safety and efficacy requirements considered necessary to obtain market authorization of disinfectants and disinfectant-sanitizers regulated under the Food and Drugs Act and Food and Drug Regulations. The proposed revisions to this guidance document draw upon the long standing regulatory and scientific basis for the evaluation of disinfectant products by other regulators, most notably the United States Environmental Protection Agency (U.S. EPA) and the United States Food and Drug Administration (FDA), the guidance for North American Free Trade Agreement (NAFTA) labelling of hard surface disinfectants, and ongoing Organization for Economic Cooperation and Development (OECD) harmonization goals."
For interest to microbiologists and cleanroom users is that intention that the following is included:
Posted by Tim Sandle
The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms
According to Health Canada:
"This document has been created to provide a more user friendly and comprehensive overview of the safety and efficacy requirements considered necessary to obtain market authorization of disinfectants and disinfectant-sanitizers regulated under the Food and Drugs Act and Food and Drug Regulations. The proposed revisions to this guidance document draw upon the long standing regulatory and scientific basis for the evaluation of disinfectant products by other regulators, most notably the United States Environmental Protection Agency (U.S. EPA) and the United States Food and Drug Administration (FDA), the guidance for North American Free Trade Agreement (NAFTA) labelling of hard surface disinfectants, and ongoing Organization for Economic Cooperation and Development (OECD) harmonization goals."
For interest to microbiologists and cleanroom users is that intention that the following is included:
- well established test methods [for example (e.g.) Association of Analytical Communities standard methods) and more recent test methods (e.g. towelette protocols];
- the inclusion of more detailed efficacy requirements to specify the recommended criteria for assessing disinfectant drugs, in tables based on microorganism type;
Posted by Tim Sandle
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