You searched for: procesvalidering (Danska - Engelska)

procesvalidering og/eller -vurdering
process validation and/or evaluation

procesvalidering ved det direkte involverede personale.
process validation by the personnel directly involved.

metallerne kan kontrolleres gennem procesvalidering eller frigivelsestest.
control of these metals can be achieved either through process validation or release test.

fremstillingsproces for det eller de virksomme stoffer, med undtagelse af data om procesvalidering
manufacturing process of the active substance(s), with the exception of data on process validation;

skal inkluderes som frigivelsestests eller kontrolleres gennem procesvalidering, hvis kvantiseringsgrænsen overskrides.
needs to be included as release test or controlled through process validation if above limit of quantitation

og som fremstilles af en anden person end ansøgeren, kan denne sørge for, at fremstilleren af det virksomme stof fremsender en detaljeret beskrivelse af fremstillingsmetoden, kvalitetskontrollen under fremstilling og procesvalidering direkte til de kompetente myndigheder.
- an active ingredient described in the european pharmacopoeia or in the pharmacopoeia of a member state when prepared by a method liable to leave impurities not mentioned in the pharmacopoeial monograph and for which the monograph is inappropriate adequately to control its quality, which is manufactured by a person different from the applicant, the latter may arrange for the detailed description of the manufacturing method, quality control during manufacture and process validation to be supplied directly to the competent authorities by the manufacturer of the active ingredient.

under kvantiseringsgrænsen * under kvantiseringsgrænsen * under kvantiseringsgrænsen * under kvantiseringsgrænsen * under kvantiseringsgrænsen * * skal inkluderes som frigivelsestests eller kontrolleres gennem procesvalidering, hvis kvantiseringsgrænsen overskrides.
below limit of quantitation* below limit of quantitation* below limit of quantitation* below limit of quantitation* below limit of quantitation*