ICH stability testing guidelines MCQs With Answer

Introduction:

ICH stability testing guidelines MCQs With Answer

Stability testing is a cornerstone of pharmaceutical quality assurance and regulatory compliance. This set of 20 carefully designed MCQs targets M.Pharm students preparing for quality management and regulatory topics, focusing on ICH stability principles, study design, climatic zones, photostability, bracketing/matrixing, stress testing, and statistical evaluation. Each question explores practical and regulatory aspects—batch selection, storage conditions, testing frequency, packaging impacts, and interpretation of stability data—helping students deepen conceptual understanding and apply guidelines to real-life drug development and shelf-life assignments.

Q1. What is the primary objective of conducting stability studies as per ICH guidelines?

• To develop manufacturing processes for scale-up
• To establish storage conditions and shelf life that ensure quality, safety and efficacy
• To determine marketing strategies and pricing
• To set impurity limits unrelated to product stability

Correct Answer: To establish storage conditions and shelf life that ensure quality, safety and efficacy

Q2. According to ICH Q1A, how many primary batches of a new drug product are generally recommended for long-term stability studies?

• One production-scale batch
• Two pilot-scale batches
• At least three production-scale batches
• Ten small-scale laboratory batches

Correct Answer: At least three production-scale batches

Q3. Which of the following storage conditions corresponds to ICH climatic Zone II for long-term testing?

• 30°C / 75% RH
• 25°C / 60% RH
• 40°C / 75% RH
• 5°C / ambient RH

Correct Answer: 25°C / 60% RH

Q4. What are the standard accelerated stability testing conditions recommended by ICH Q1A?

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

Correct Answer: 40°C / 75% RH

Q5. The main purpose of ICH Q1B photostability testing is to:

• Measure thermal degradation under high temperature only
• Assess the impact of light exposure on drug substance and product and determine need for light-protective packaging
• Evaluate microbial stability when exposed to light
• Replace accelerated stability testing

Correct Answer: Assess the impact of light exposure on drug substance and product and determine need for light-protective packaging

Q6. Which statement best describes bracketing and matrixing designs in stability studies?

• Bracketing tests all strengths; matrixing tests none
• Bracketing tests only extremes of design space while matrixing tests a selected subset of all possible samples over time
• Matrixing requires testing every batch at every time point; bracketing is statistical analysis only
• Both designs mandate testing every strength at every time point

Correct Answer: Bracketing tests only extremes of design space while matrixing tests a selected subset of all possible samples over time

Q7. Forced degradation (stress testing) in stability programs is primarily performed to:

• Define packaging materials exclusively
• Identify likely degradation products and develop/validate stability-indicating analytical methods
• Shorten shelf-life without scientific justification
• Replace long-term stability studies

Correct Answer: Identify likely degradation products and develop/validate stability-indicating analytical methods

Q8. How does a ‘retest period’ for a drug substance differ from a product ‘shelf life’?

• Retest period applies to finished products; shelf life applies only to active substances
• Retest period indicates when a drug substance must be retested and may be reworked; shelf life is the time a finished product remains acceptable under specified conditions
• They are identical in meaning and application
• Retest period is always longer than shelf life

Correct Answer: Retest period indicates when a drug substance must be retested and may be reworked; shelf life is the time a finished product remains acceptable under specified conditions

Q9. Why is selection of an appropriate primary packaging system critical in stability studies?

• Primary packaging only affects marketing, not stability
• Packaging can interact with the product or provide barrier properties that significantly affect chemical, physical and microbiological stability
• Packaging selection is solely a cost-driven decision
• Regulators do not consider packaging during stability assessment

Correct Answer: Packaging can interact with the product or provide barrier properties that significantly affect chemical, physical and microbiological stability

Q10. Typical time points recommended for accelerated stability testing under ICH are:

• 0 and 24 months only
• 0, 3 and 6 months
• 12, 18 and 24 months
• Every month for 36 months

Correct Answer: 0, 3 and 6 months

Q11. Under what circumstance is intermediate (e.g., 30°C/65% RH) stability testing required between long-term and accelerated studies?

• Always required for all products regardless of accelerated results
• Required when accelerated testing shows a significant change in the product
• Only required for refrigerated products
• Never required according to ICH

Correct Answer: Required when accelerated testing shows a significant change in the product

Q12. ICH Q1E provides guidance on which aspect of stability data?

• Requirements for formulation excipients only
• Statistical approaches for evaluating stability data and establishing shelf life
• Manufacturing site qualification
• Packaging aesthetics

Correct Answer: Statistical approaches for evaluating stability data and establishing shelf life

Q13. Which ICH climatic zone classification corresponds to a hot and very humid environment (e.g., 30°C/75% RH)?

• Zone I
• Zone II
• Zone IVb
• Zone III

Correct Answer: Zone IVb

Q14. What minimum light exposure levels are recommended in ICH Q1B for photostability testing (visible and near-UV)?

• Visible: 100,000 lux·h; Near-UV: 10 W·h/m2
• Visible: 1.2 million lux·h; Near-UV: 200 W·h/m2
• Visible: 10 million lux·h; Near-UV: 5,000 W·h/m2
• There are no recommended exposure levels in ICH Q1B

Correct Answer: Visible: 1.2 million lux·h; Near-UV: 200 W·h/m2

Q15. Bracketing can be scientifically justified when:

• Different strengths have different formulations and manufacturing processes
• Strengths differ only in the amount of API but share the same composition and manufacturing process, allowing extremes to represent intermediates
• Product contains multiple incompatible excipients
• No stability data exist for any strength

Correct Answer: Strengths differ only in the amount of API but share the same composition and manufacturing process, allowing extremes to represent intermediates

Q16. A stability-indicating analytical method is best described as:

• A method that measures only impurities, not the active drug
• An assay that can accurately quantify the active pharmaceutical ingredient without interference from degradation products, impurities or excipients
• A method used only for microbial testing
• A non-specific physical test like pH measurement

Correct Answer: An assay that can accurately quantify the active pharmaceutical ingredient without interference from degradation products, impurities or excipients

Q17. Which elements are considered part of the container-closure system in stability assessment?

• Only the external shipping carton
• Primary components in direct contact with product such as bottle, cap, stopper, blister foil, and any inner liners
• Only secondary packaging used for marketing
• Laboratory glassware used during testing

Correct Answer: Primary components in direct contact with product such as bottle, cap, stopper, blister foil, and any inner liners

Q18. For most oral solid dosage forms, how long is the accelerated study usually performed to observe significant changes?

• 1 week
• 1 month
• 6 months
• 5 years

Correct Answer: 6 months

Q19. ICH photostability guideline Q1B applies to which of the following?

• Only drug substances
• Only finished drug products
• Both drug substances and finished drug products
• Only packaging materials

Correct Answer: Both drug substances and finished drug products

Q20. To justify assigning a shelf life beyond the observed real-time data (extrapolation), ICH guidance requires:

• No data; extrapolation is forbidden under all circumstances
• Sufficient supportive stability data, appropriate statistical analysis, and scientific rationale such as kinetic modeling or additional batches
• Only accelerated data without long-term data
• A vote by the development team without documented analysis

Correct Answer: Sufficient supportive stability data, appropriate statistical analysis, and scientific rationale such as kinetic modeling or additional batches

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