demande d'autorisation de libération en fonction des paramètres

OBS: Mécanisme d'autorisation des procédés et méthodes employés par les fabricants de produits pharmaceutiques stériles.
OBS: Santé Canada.

OBS: Parametric release can be used as an operational alternative to routine release testing for the drug product. Sterility testing for terminally sterilized drug products is one example. In this case, the release of a batch is based on results from monitoring specific parameters e.g., temperature and pressure, during the terminal sterilization phase(s) of drug product manufacturing. These parameters can generally be more measured, so that they are more reliable in predicting sterility assurance than is end-product sterility testing. It is important to note that the sterilization process should be adequately validated before parametric release is proposed. When parametric release is performed, the attribute which is indirectly controlled (e.g., sterility), together with a reference to the associated test procedure, still should be included in the specifications.
OBS: Health Canada.