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DEMANDE AUTORISATION LIBERATION FONCTION PARAMETRES [1 record]
Record 1 - internal organization data 1998-03-23
Record 1, English
Record 1, Subject field(s)
- Pharmacology
- Pharmaceutical Manufacturing
Record 1, Main entry term, English
- process parametric release submission 1, record 1, English, process%20parametric%20release%20submission
Record 1, Abbreviations, English
Record 1, Synonyms, English
- PPR submission 1, record 1, English, PPR%20submission
Record 1, Textual support, English
Record number: 1, Textual support number: 1 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. 1, record 1, English, - process%20parametric%20release%20submission
Record number: 1, Textual support number: 2 OBS
Health Canada. 1, record 1, English, - process%20parametric%20release%20submission
Record 1, French
Record 1, Domaine(s)
- Pharmacologie
- Fabrication des produits pharmaceutiques
Record 1, Main entry term, French
- demande d'autorisation de libération en fonction des paramètres
1, record 1, French, demande%20d%27autorisation%20de%20lib%C3%A9ration%20en%20fonction%20des%20param%C3%A8tres
feminine noun
Record 1, Abbreviations, French
Record 1, Synonyms, French
Record 1, Textual support, French
Record number: 1, Textual support number: 1 OBS
Mécanisme d'autorisation des procédés et méthodes employés par les fabricants de produits pharmaceutiques stériles. 1, record 1, French, - demande%20d%27autorisation%20de%20lib%C3%A9ration%20en%20fonction%20des%20param%C3%A8tres
Record number: 1, Textual support number: 2 OBS
Santé Canada. 1, record 1, French, - demande%20d%27autorisation%20de%20lib%C3%A9ration%20en%20fonction%20des%20param%C3%A8tres
Record 1, Spanish
Record 1, Textual support, Spanish
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