QUALITY CONTROL 2 LEC: *If long-term studies are conducted at 25°C ± 2°C/60% RH ±
5% RH and “significant change” occurs at any time during 6
months’ testing at the accelerated storage condition,

what will happen?

Question

*If long-term studies are conducted at 25°C ± 2°C/60% RH ±
5% RH and “significant change” occurs at any time during 6
months’ testing at the accelerated storage condition,

what will happen?

LEIGHTON DWIGHT OBILLOS · Accepted Answer

additional testing at the intermediate storage condition should be conducted and evaluated against significant change criteria.

QUALITY CONTROL 2 LEC

*If long-term studies are conducted at 25°C ± 2°C/60% RH ± 5% RH and “significant change” occurs at any time during 6 months’ testing at the accelerated storage condition, what will happen?

Additional testing at the intermediate storage condition should be conducted and evaluated against significant change criteria.

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