ICH guidelines on quality, safety and efficacy MCQs With Answer

Introduction: This quiz collection on ICH guidelines for quality, safety and efficacy is designed specifically for M.Pharm students preparing for exams in Good Regulatory Practices. It provides focused multiple-choice questions that probe core principles of key ICH documents (Q, S, E and M series) such as stability, impurities, pharmaceutical development, nonclinical safety and clinical trial standards. Each question highlights practical regulatory expectations, guideline scope and application in dossier preparation, control strategy and lifecycle management. Use these MCQs to test your conceptual understanding, reinforce guideline references and improve readiness for regulatory submissions, inspections and academic assessments.

Q1. What is the primary objective of the International Council for Harmonisation (ICH)?

• To harmonize technical requirements for pharmaceutical registration across major regions
• To create a single global pharmacopoeia
• To replace national regulatory authorities with a central agency
• To set prices for medicines internationally

Correct Answer: To harmonize technical requirements for pharmaceutical registration across major regions

Q2. The Common Technical Document (CTD) is described in which ICH M guideline?

• M1 — Electronic Standards for the Transfer of Regulatory Information
• M4 — Common Technical Document (CTD)
• M7 — Assessment of Genotoxic Impurities
• Q8 — Pharmaceutical Development

Correct Answer: M4 — Common Technical Document (CTD)

Q3. Which ICH guideline introduced the concepts of Quality by Design (QbD), design space and control strategy?

• Q2(R1) — Analytical Validation
• Q8(R2) — Pharmaceutical Development
• Q3A — Impurities in New Drug Substances
• Q10 — Pharmaceutical Quality System

Correct Answer: Q8(R2) — Pharmaceutical Development

Q4. ICH Q9 is primarily concerned with which topic?

• Good Clinical Practice
• Quality Risk Management
• Nonclinical Safety Testing
• Electronic Common Technical Document

Correct Answer: Quality Risk Management

Q5. The scope of ICH Q10 mainly covers which area?

• Analytical method validation requirements
• Pharmaceutical Quality System and lifecycle management
• Clinical trial design for oncology
• Elemental impurity limits in drug products

Correct Answer: Pharmaceutical Quality System and lifecycle management

Q6. Which ICH guideline addresses assessment and control of DNA reactive (mutagenic) impurities and introduces the Threshold of Toxicological Concern (TTC) concept?

• Q3C — Residual Solvents
• M7 — Assessment and Control of DNA Reactive (Mutagenic) Impurities
• Q6A — Specifications
• S1 — Carcinogenicity Testing

Correct Answer: M7 — Assessment and Control of DNA Reactive (Mutagenic) Impurities

Q7. In ICH Q3C residual solvent classification, which class contains solvents with low toxic potential and permitted high daily exposures?

• Class 1 — Solvents to be avoided
• Class 2 — Solvents to be limited
• Class 3 — Solvents with low toxic potential
• Class 4 — Non-classified solvents

Correct Answer: Class 3 — Solvents with low toxic potential

Q8. Stability testing requirements for new drug substances and products are defined in which ICH guideline?

• Q1A(R2) — Stability Testing of New Drug Substances and Products
• Q2(R1) — Analytical Method Validation
• Q3A(R2) — Impurities in New Drug Substances
• M4 — Common Technical Document

Correct Answer: Q1A(R2) — Stability Testing of New Drug Substances and Products

Q9. According to ICH Q2(R1), which of the following lists contains the principal analytical validation parameters?

• Specificity, accuracy, precision, detection limit, quantitation limit, linearity and range
• Safety, efficacy, stability and pharmacokinetics
• Design space, control strategy, product quality and labeling
• Impurity profile, solvent class, elemental impurities and dosage form

Correct Answer: Specificity, accuracy, precision, detection limit, quantitation limit, linearity and range

Q10. Which ICH guideline provides recommendations for establishing specifications (test procedures and acceptance criteria) for new drug substances and products?

• Q6A — Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and Products
• Q3D — Elemental Impurities
• Q1A — Stability Testing
• E6 — Good Clinical Practice

Correct Answer: Q6A — Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and Products

Q11. Which ICH guideline is the international standard for Good Clinical Practice?

• E2B — Electronic Transmission of Individual Case Safety Reports
• E6(R2) — Good Clinical Practice
• E5 — Ethnic Factors in the Acceptability of Foreign Clinical Data
• S1 — Carcinogenicity Testing

Correct Answer: E6(R2) — Good Clinical Practice

Q12. Which guideline addresses the acceptability of foreign clinical data and the concept of bridging studies related to ethnic factors?

• E5(R1) — Ethnic Factors in the Acceptability of Foreign Clinical Data
• E17 — Multi-Regional Clinical Trials
• Q8 — Pharmaceutical Development
• M4 — Common Technical Document

Correct Answer: E5(R1) — Ethnic Factors in the Acceptability of Foreign Clinical Data

Q13. The ICH E17 guideline provides principles for which type of clinical trial?

• Single-center dose escalation studies
• Multi-Regional Clinical Trials (MRCTs)
• Nonclinical reproductive toxicity studies
• Bioequivalence studies for generics only

Correct Answer: Multi-Regional Clinical Trials (MRCTs)

Q14. Which guideline gives nonclinical safety evaluation recommendations specifically for biotechnology-derived pharmaceuticals?

• S6(R1) — Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
• S3A — Detection of Repeated Dose Toxicity
• S9 — Nonclinical Evaluation for Anticancer Pharmaceuticals
• Q3A — Impurities in New Drug Substances

Correct Answer: S6(R1) — Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

Q15. Which ICH guideline specifically targets impurities in new drug substances?

• Q3A(R2) — Impurities in New Drug Substances
• Q3C — Residual Solvents
• Q3D — Elemental Impurities
• M7 — Mutagenic Impurities

Correct Answer: Q3A(R2) — Impurities in New Drug Substances

Q16. ICH Q3D provides guidance on which regulatory concern?

• Analytical method validation
• Elemental impurities (metals) in drug products
• Photostability testing
• Clinical trial design

Correct Answer: Elemental impurities (metals) in drug products

Q17. In the CTD structure, Module 3 primarily contains which type of information?

• Quality information on drug substance and drug product
• Nonclinical study reports
• Clinical study reports and summaries
• Regional administrative information

Correct Answer: Quality information on drug substance and drug product

Q18. Which ICH guideline standardizes the electronic transmission format for Individual Case Safety Reports (ICSRs)?

• E2B(R3) — Electronic Transmission of Individual Case Safety Reports
• E6(R2) — Good Clinical Practice
• M4 — Common Technical Document
• Q1A — Stability Testing

Correct Answer: E2B(R3) — Electronic Transmission of Individual Case Safety Reports

Q19. Which ICH guideline formally introduced the concepts of Quality Target Product Profile (QTPP), critical quality attributes (CQAs) and design space?

• Q8(R2) — Pharmaceutical Development
• Q9 — Quality Risk Management
• Q10 — Pharmaceutical Quality System
• Q3A — Impurities

Correct Answer: Q8(R2) — Pharmaceutical Development

Q20. Which ICH guideline specifically addresses technical and regulatory considerations for pharmaceutical product lifecycle management, including post-approval changes?

• Q12 — Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
• Q6A — Specifications
• M4 — Common Technical Document
• E5 — Ethnic Factors

Correct Answer: Q12 — Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

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