GPAT Practice Quiz

Question 1

According to ICH Q1A(R2), which long-term storage condition is generally recommended for stability testing of a drug product intended for general storage at room temperature in climatic zones I and II?

Accepted Answer

25°C ± 2°C / 60% RH ± 5% RH

Question 2

Under ICH stability guidance, what is the usual accelerated testing condition for a drug product stored at room temperature?

Accepted Answer

40°C ± 2°C / 75% RH ± 5% RH

Question 3

During photostability testing as per ICH Q1B, what is the primary reason for including dark controls?

Accepted Answer

To distinguish changes caused by light from those caused by heat or other environmental factors

Question 4

A manufacturer proposes a 36-month shelf life for a drug product, but only 12 months of long-term data are available at submission. Under ICH Q1E, what is the key principle governing whether extrapolation beyond observed data may be acceptable?

Accepted Answer

Extrapolation may be justified when the stability profile shows little variability, no significant change, and supporting accelerated or intermediate data

Question 5

A drug product shows a significant change at accelerated conditions within 6 months. According to ICH Q1A(R2), what is the appropriate next step for products intended for room-temperature storage?

Accepted Answer

Initiate testing at intermediate conditions such as 30°C ± 2°C / 65% RH ± 5% RH

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