CLPT, M.Pharmacy, Pharmaceutical Regulatory Affairs

The topics included under ICH are

• Quality

• Safety

• Efficacy

• All

The countries included under ICH are

• European Union

• Japan

• USA

• All

Which is correct guidelines for stability testing

• ICH Q3

• ICH Q10

• ICHQ8

• ICHQ1

Data from stability studies should be provided on at least ................... primary batches of the drug product.

• 4

• 3

• 2

• 5

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as ..........................................., and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions

• Temperature, and light

• Heat, temperature, and light

• Temperature, humidity, and light

• Temperature, humidity, and moisture

For Intermediate stability studies as per the ICH guidelines which storage condition for the drug substance is applicable

• 25°C ± 2°C/60% RH ± 5% RH

• 30°C ± 2°C/65% RH ± 5% RH

• 40°C ± 2°C/75% RH ± 5% RH

• None

For Accelerated stability studies as per the ICH guidelines which storage condition for the drug substance is applicable

• 40°C ± 2°C/75% RH ± 5% RH

• 30°C ± 2°C/65% RH ± 5% RH

• 25°C ± 2°C/60% RH ± 5% RH

• None

For long term stability studies as per the ICH guidelines which storage condition for the drug substances intended for storage in a refrigerator is applicable

• 25°C ± 2°C/60% RH ± 5% RH

• 5°C ± 3°C

• 30°C ± 2°C/65% RH ± 5% RH

• 40°C ± 2°C/75% RH ± 5% RH

For Accelerated stability studies as per the ICH guidelines which storage condition for the drug substances intended for storage in a refrigerator is applicable

• 5°C ± 3°C

• 25°C ± 2°C/60% RH ± 5% RH

• 30°C ± 2°C/65% RH ± 5% RH

• 25°C ± 2°C/60% RH ± 5% RH

For long term stability studies as per the ICH guidelines which storage condition for the drug substances intended for storage in a freezer is applicable

• 5°C ± 3°C

• - 20°C ± 5°C

• 25°C ± 2°C/60% RH ± 5% RH

• 30°C ± 2°C/65% RH ± 5% RH