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pri inaktiviranih ali detoksificiranih cepivih, je treba inaktivacijo ali detoksifikacijo preskusiti med vsakim procesom izdelave, ki neposredno sledi procesu inaktivacije ali detoksifikacije.
for inactivated or detoxified vaccines, inactivation or detoxification shall be tested during each production run immediately after the inactivation or detoxification process.
pri inaktiviranih ali detoksificiranih cepivih se preveri učinkovitost inaktivacije ali detoksifikacije med proizvodnjo vsake serije, razen če nadzor ni odvisen od preskusa, za katerega je razpoložljivost dovzetnih živali omejena.
for inactivated or detoxified vaccines, effective inactivation or detoxification shall be verified during each production run, unless this control is dependent upon a test for which the availability of susceptible animals is limited.