ICH Q, S, E, M guidelines MCQs With Answer

ICH Q, S, E, M guidelines MCQs With Answer offers a focused way for M. Pharm students to master the most testable and practice-relevant aspects of ICH harmonized guidelines used in global drug development and regulation. This quiz set covers Quality (Q) topics such as QbD, risk management, PQS, lifecycle management, analytical and continuous manufacturing; Safety (S) testing strategies; Efficacy (E) clinical principles; and Multidisciplinary (M) topics like CTD, mutagenic impurities, BCS-based biowaivers, and bioanalytical validation. Each question is designed to probe conceptual clarity, regulatory intent, and practical application, aligning with MPH 104T (Regulatory Affairs). Use these MCQs to assess understanding, reinforce compliance thinking, and build exam and interview readiness.

Q1. In ICH Q8(R2), what best describes a “design space”?

• A multidimensional combination and interaction of input variables and process parameters that provide assurance of quality
• A predefined range of analytical performance characteristics for an ATP
• A regulatory reporting category for post-approval changes
• A stability testing protocol for accelerated conditions

Correct Answer: A multidimensional combination and interaction of input variables and process parameters that provide assurance of quality

Q2. Which of the following is a recommended risk assessment tool under ICH Q9(R1)?

• Failure Mode and Effects Analysis (FMEA)
• Design of Experiments (DoE)
• 5S workplace organization
• Gauge R&R study

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q3. Which is NOT a key element of the ICH Q10 Pharmaceutical Quality System?

• Corrective and Preventive Action (CAPA)
• Change Management System
• Management Review
• Equipment qualification and calibration program

Correct Answer: Equipment qualification and calibration program

Q4. In ICH Q12, which concept links the control strategy to regulatory change management categories by defining what must be reported upon change?

• Established Conditions (ECs)
• Critical Quality Attribute (CQA)
• Quality Risk Management (QRM)
• Specification

Correct Answer: Established Conditions (ECs)

Q5. Under ICH Q13, which concept is uniquely emphasized for pharmaceutical continuous manufacturing control strategies?

• Material diversion strategy to manage transient nonconforming output
• Mandatory terminal sterilization
• Exclusion of real-time release testing
• Reliance solely on end-product testing

Correct Answer: Material diversion strategy to manage transient nonconforming output

Q6. Which statement about the Analytical Target Profile (ATP) in ICH Q14 is correct?

• It prospectively defines the intended purpose and minimum performance criteria of an analytical procedure, independent of technique
• It is equivalent to system suitability criteria for a chromatographic method
• It is synonymous with the analytical method SOP
• It applies only to bioanalytical methods

Correct Answer: It prospectively defines the intended purpose and minimum performance criteria of an analytical procedure, independent of technique

Q7. According to ICH Q2(R2), which of the following is NOT an analytical procedure validation characteristic?

• Specificity
• System suitability
• Precision
• Linearity

Correct Answer: System suitability

Q8. In ICH Q3C(R8), into which class is benzene categorized as a residual solvent?

• Class 1 (carcinogenic and strongly toxic)
• Class 2 (non-genotoxic animal carcinogens or reversible toxicities)
• Class 3 (low toxic potential)
• Not classified

Correct Answer: Class 1 (carcinogenic and strongly toxic)

Q9. What is the preferred approach in ICH Q3D(R2) for controlling elemental impurities in drug products?

• A risk assessment–based control strategy across raw materials, manufacturing, packaging, and product
• Routine 100% batch testing for all elements in all products
• End-product testing only with relaxed limits vs. PDEs
• Tightening drug product specifications without process controls

Correct Answer: A risk assessment–based control strategy across raw materials, manufacturing, packaging, and product

Q10. Which ICH guideline enables weight-of-evidence–based waivers of the two-year rat carcinogenicity study in certain cases?

• ICH S1B(R1)
• ICH S2(R1)
• ICH S9
• ICH E14

Correct Answer: ICH S1B(R1)

Q11. What constitutes the core genotoxicity battery per ICH S2(R1)?

• A bacterial reverse mutation assay and a mammalian cell assay for chromosomal damage, with in vivo follow-up as needed
• hERG assay plus telemetered dog QT assessment
• A two-year rat carcinogenicity study
• A plant cell micronucleus test

Correct Answer: A bacterial reverse mutation assay and a mammalian cell assay for chromosomal damage, with in vivo follow-up as needed

Q12. ICH S5(R3) primarily addresses which nonclinical evaluation area?

• Male fertility and early embryonic development, embryo-fetal development, and pre- and postnatal development
• Carcinogenicity in rodents
• Immunotoxicity of biotherapeutics
• Phototoxic potential of topicals

Correct Answer: Male fertility and early embryonic development, embryo-fetal development, and pre- and postnatal development

Q13. ICH S7B focuses on which primary endpoints?

• IKr/hERG current inhibition and in vivo QT/QTc prolongation
• Acute LD50 determination in rodents
• Renal clearance in rats
• Hepatic microsomal stability

Correct Answer: IKr/hERG current inhibition and in vivo QT/QTc prolongation

Q14. What is a key addition in the ICH E6(R2) addendum to GCP?

• Risk-based quality management and proportionate monitoring
• Waiver of informed consent in all minimal-risk studies
• Elimination of source data verification
• Mandatory electronic informed consent in all studies

Correct Answer: Risk-based quality management and proportionate monitoring

Q15. In the ICH E9(R1) estimand framework, which is NOT a component of an estimand?

• Population
• Intercurrent event handling strategy
• Randomization schedule
• Summary measure of treatment effect

Correct Answer: Randomization schedule

Q16. In ICH E14, which positive control is typically used in a Thorough QT (TQT) study?

• Moxifloxacin
• Warfarin
• Caffeine
• Ketoconazole

Correct Answer: Moxifloxacin

Q17. In the ICH M4 Common Technical Document (CTD), what does Module 3 contain?

• Quality (CMC) information
• Nonclinical study reports
• Clinical study reports
• Region-specific administrative information

Correct Answer: Quality (CMC) information

Q18. Under ICH M7(R2), what is required when using computational methods to assess mutagenic potential of impurities?

• Two complementary QSAR methods (rule-based and statistical) with expert review
• A single QSAR model is sufficient
• QSAR predictions are not accepted
• Only in vitro bacterial testing is needed

Correct Answer: Two complementary QSAR methods (rule-based and statistical) with expert review

Q19. Which statement about ICH M9 BCS-based biowaivers is correct?

• BCS Class I and Class III drug products may be eligible under defined conditions (e.g., high solubility/permeability for Class I; high solubility with very rapid dissolution and excipient risk assessment for Class III)
• Only BCS Class II drugs are eligible
• All injectable products are eligible
• BCS Class IV drugs are eligible with dissolution testing alone

Correct Answer: BCS Class I and Class III drug products may be eligible under defined conditions (e.g., high solubility/permeability for Class I; high solubility with very rapid dissolution and excipient risk assessment for Class III)

Q20. Which is NOT a typical parameter in ICH M10 bioanalytical method validation?

• Accuracy (trueness) and precision
• Selectivity and carryover
• Stability and dilution integrity
• Intent-to-treat analysis

Correct Answer: Intent-to-treat analysis

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