QUALITY CONTROL 2 LEC: In the absence of an accelerated storage condition for drug
substances intended to be stored in a freezer, __ should be
conducted to address the effect of short term excursions
outside the proposed label storage condition, e.g., during
shipping or handling.

Question

In the absence of an accelerated storage condition for drug
substances intended to be stored in a freezer, __ should be
conducted to address the effect of short term excursions
outside the proposed label storage condition, e.g., during
shipping or handling.

LEIGHTON DWIGHT OBILLOS · Accepted Answer

testing on a
single batch at an elevated temperature (e.g., 5°C ± 3°C
or 25°C ± 2°C) for an appropriate time period

QUALITY CONTROL 2 LEC

In the absence of an accelerated storage condition for drug substances intended to be stored in a freezer, __ should be conducted to address the effect of short term excursions outside the proposed label storage condition, e.g., during shipping or handling.

Testing on a single batch at an elevated temperature (e.g., 5°C ± 3°C or 25°C ± 2°C) for an appropriate time period

Autor