ICH stability testing guidelines MCQs With Answer

Understanding ICH stability testing guidelines MCQs With Answer is essential for B. Pharm students preparing for exams and professional work. This concise, keyword-rich introduction covers ICH guidelines, stability testing principles, storage conditions, accelerated and long-term studies, photostability, stress testing, stability-indicating methods, shelf life assignment, climatic zones, and container-closure considerations. It explains protocol design, bracketing and matrixing, retest period versus shelf life, and post-approval stability commitments. Mastery of these topics helps in setting specifications, designing studies, interpreting data, and ensuring drug product quality throughout its lifecycle. These MCQs include answers and explanations to deepen your practical understanding. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary objective of ICH Q1A(R2) stability testing guideline?

• To define manufacturing steps for active pharmaceutical ingredients
• To provide guidance on stability testing to establish shelf life and storage conditions
• To regulate advertising claims for finished products
• To specify clinical trial protocols for new drugs

Correct Answer: To provide guidance on stability testing to establish shelf life and storage conditions

Q2. Which of the following best describes “accelerated stability testing” per ICH?

• Testing at lower-than-normal temperatures to predict long-term stability
• Testing under exaggerated conditions like high temperature and humidity to speed up degradation
• Testing only under photostability conditions
• Testing in clinical trial volunteers for degradation products

Correct Answer: Testing under exaggerated conditions like high temperature and humidity to speed up degradation

Q3. For a drug product intended for storage in climatic Zone II, the typical ICH long-term condition is:

• 30°C ± 2°C / 65% RH ± 5% RH
• 25°C ± 2°C / 60% RH ± 5% RH
• 40°C ± 2°C / 75% RH ± 5% RH
• 5°C ± 3°C / refrigerate conditions

Correct Answer: 25°C ± 2°C / 60% RH ± 5% RH

Q4. Which ICH guideline specifically addresses photostability testing of new drug substances and products?

• Q1A(R2)
• Q1B
• Q3C
• Q5C

Correct Answer: Q1B

Q5. What is a “stability-indicating method”?

• An analytical method that only quantifies the active ingredient
• An analytical method that can accurately measure a drug and separate it from its degradation products
• A method that increases drug stability during storage
• A method used only for microbiological testing

Correct Answer: An analytical method that can accurately measure a drug and separate it from its degradation products

Q6. Bracketing and matrixing approaches are allowed in stability testing to:

• Eliminate the need for any stability data
• Reduce the number of samples tested while still obtaining representative stability data
• Test every single batch for full shelf life
• Substitute accelerated studies for long-term studies entirely

Correct Answer: Reduce the number of samples tested while still obtaining representative stability data

Q7. “Retest period” refers to:

• The time within which a finished product must be used after opening
• The time during which an API can be stored before being used in manufacture
• The total shelf life of the finished product
• The interval between stability study time points

Correct Answer: The time during which an API can be stored before being used in manufacture

Q8. Forced degradation (stress testing) is used to:

• Determine only the potency of the drug
• Identify degradation pathways and develop stability-indicating methods
• Replace long-term stability studies
• Assess patient tolerability under extreme conditions

Correct Answer: Identify degradation pathways and develop stability-indicating methods

Q9. Which condition is typically used for ICH accelerated stability testing in Zone II?

• 5°C ± 3°C
• 25°C ± 2°C / 60% RH ± 5% RH
• 40°C ± 2°C / 75% RH ± 5% RH
• 30°C ± 2°C / 65% RH ± 5% RH

Correct Answer: 40°C ± 2°C / 75% RH ± 5% RH

Q10. Photostability testing aims to evaluate:

• Microbial contamination under light exposure
• The effect of light on chemical degradation and physical properties of drug substances and products
• The product’s resistance to high temperature only
• Only the packaging material’s color change

Correct Answer: The effect of light on chemical degradation and physical properties of drug substances and products

Q11. Which of the following is part of a stability protocol?

• Analytical methods and specifications
• Marketing strategy
• Clinical dosing schedule
• Sales forecasts

Correct Answer: Analytical methods and specifications

Q12. A stability-indicating assay should be validated for:

• Specificity, accuracy, precision, and robustness
• Packaging aesthetics
• Marketing claims
• Only linearity and range

Correct Answer: Specificity, accuracy, precision, and robustness

Q13. According to ICH, which study is mandatory for new drug submissions to demonstrate long-term behavior?

• Only accelerated studies
• Long-term stability studies under recommended conditions
• Only photostability tests
• Only in-use stability tests

Correct Answer: Long-term stability studies under recommended conditions

Q14. In bracketing, which samples are typically tested?

• All strengths and container sizes
• Only the extremes (e.g., highest and lowest strengths or sizes)
• Only middle-strength samples
• No samples are tested

Correct Answer: Only the extremes (e.g., highest and lowest strengths or sizes)

Q15. What is the primary reason for including container-closure system evaluation in stability studies?

• To determine marketing claims for packaging
• To ensure the system protects product quality and does not interact adversely with the drug
• To test color fastness of labels
• To reduce manufacturing costs

Correct Answer: To ensure the system protects product quality and does not interact adversely with the drug

Q16. Intermediate stability testing is used when:

• Long-term studies show no change and accelerated tests are not required
• Accelerated studies indicate potential stability problems and more data are needed
• No stability data is available
• Only photostability is of concern

Correct Answer: Accelerated studies indicate potential stability problems and more data are needed

Q17. Which ICH concept allows using accelerated data to predict shelf life under certain conditions?

• Biowaiver
• Arrhenius-based extrapolation and Q1E statistical approaches
• Good Manufacturing Practice
• ICH Q3 stability reporting

Correct Answer: Arrhenius-based extrapolation and Q1E statistical approaches

Q18. For lyophilized products, stability studies should generally evaluate:

• Only the reconstituted solution
• Both the lyophilized cake and reconstituted solution stability
• Only visual appearance of the cake
• Only microbial limits after reconstitution

Correct Answer: Both the lyophilized cake and reconstituted solution stability

Q19. Which parameter is NOT typically monitored in a stability study?

• Assay/potency
• Degradation products/impurities
• Packaging compressive strength for transit only
• Physical appearance and dissolution

Correct Answer: Packaging compressive strength for transit only

Q20. What does “post-approval stability commitment” mean?

• A requirement to submit marketing materials after approval
• A sponsor’s obligation to continue stability studies on production batches after approval
• A commitment to change storage conditions immediately after approval
• A plan to stop stability testing after approval

Correct Answer: A sponsor’s obligation to continue stability studies on production batches after approval

Q21. Which climatic zone represents hot and humid conditions most relevant for tropical regions?

• Zone I
• Zone II
• Zone III
• Zone IV

Correct Answer: Zone IV

Q22. During stability testing, “in-use” studies are most relevant for:

• Sterile bulk API storage only
• Products with multi-dose containers or complex reconstitution procedures
• Only single-dose ampoules
• Raw material packaging

Correct Answer: Products with multi-dose containers or complex reconstitution procedures

Q23. The term “shelf life” specifically refers to:

• Time after reconstitution that product remains safe
• Period during which a finished product remains within specified limits and is safe for use
• Time taken for regulatory approval
• Time to manufacture the product

Correct Answer: Period during which a finished product remains within specified limits and is safe for use

Q24. Which analytical approach increases confidence that observed changes are due to degradation and not method variability?

• Using an unvalidated assay
• Robust validation of stability-indicating analytical methods
• Running only visual inspections
• Using different methods at each time point

Correct Answer: Robust validation of stability-indicating analytical methods

Q25. During stress testing, which condition is commonly used to test hydrolytic degradation?

• Exposure to strong light only
• Acidic and basic hydrolysis conditions
• Freezing temperatures only
• Neutral pH at ambient temperature only

Correct Answer: Acidic and basic hydrolysis conditions

Q26. What is the main regulatory purpose of reporting impurities and degradation products in stability studies?

• To set limits and ensure safety over shelf life
• To increase product price
• To simplify analytical work
• To avoid stability testing

Correct Answer: To set limits and ensure safety over shelf life

Q27. If accelerated data show no significant change, what is the typical next step per ICH?

• Approve indefinite shelf life
• Continue long-term studies and use accelerated data as supportive information
• Skip long-term studies entirely
• Reduce packaging requirements

Correct Answer: Continue long-term studies and use accelerated data as supportive information

Q28. Which factor can cause an apparent change in stability results unrelated to real degradation?

• Properly validated analytical methods
• Improper sample handling and storage during study
• Consistent storage conditions
• Use of stability-indicating methods

Correct Answer: Improper sample handling and storage during study

Q29. In stability reporting, which statistical tool is often used to evaluate trends over time?

• Linear regression analysis
• Only descriptive comments without data
• Random guessing
• Blinded consumer surveys

Correct Answer: Linear regression analysis

Q30. Which of the following is TRUE regarding container-closure compatibility studies?

• They are unnecessary if packaging is attractive
• They assess extractables/leachables and suitability to protect product quality
• They only evaluate mechanical strength for shipping
• They replace the need for analytical stability testing

Correct Answer: They assess extractables/leachables and suitability to protect product quality

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