Are Good Manufacturing Practices (GMP) required for disinfectant drug products?
Requirements for GMP depend on the type of product. That is, Health Canada’s certification forms for DIN submissions and Category IV DIN submissions reflect the exemption applied to some antimicrobial products, such as low-level hard surface disinfectants, with respect to GMP. However, this exemption does not apply to higher risk disinfectant products such as contact lens disinfectants, chemosterilants and high level disinfectants used to sterilize invasive devices or devices used for circulation, reintroduction of a body fluid or for introduction in a body cavity as well as to antimicrobial drug products for use on the skin. For more information, please refer to the certification form that is available on Health Canada’s website.
