ICH Q-series – Quality guidelines overview MCQs With Answer

Introduction

ICH Q-series – Quality guidelines overview MCQs With Answer is designed for M.Pharm students to strengthen understanding of international quality expectations for pharmaceuticals. The ICH Q-series harmonizes technical requirements across major regulatory regions, covering stability, analytical validation, impurities, pharmaceutical development, GMP for APIs, and lifecycle quality management. This set of multiple-choice questions focuses on core principles, guideline scope, and practical regulatory applications. Working through these MCQs will help students grasp guideline interconnections (Q8–Q12), apply analytical and stability concepts (Q1, Q2), manage impurities (Q3), and understand quality systems and risk management (Q9, Q10). Answers are provided to support self-assessment and exam preparation.

Q1. What is the primary objective of the ICH Q-series guidelines?

• To standardize clinical trial designs across regions
• To harmonize technical requirements for pharmaceutical quality across ICH regions
• To regulate marketing and pricing of medicinal products
• To provide preclinical safety testing protocols

Correct Answer: To harmonize technical requirements for pharmaceutical quality across ICH regions

Q2. Which ICH guideline specifically addresses stability testing of new drug substances and products?

• Q2(R1) — Analytical Validation
• Q1A(R2) — Stability Testing
• Q3A(R2) — Impurities in New Drug Substances
• Q7 — GMP for Active Pharmaceutical Ingredients

Correct Answer: Q1A(R2) — Stability Testing

Q3. Which guideline provides principles and procedures for photostability testing of drug substances and products?

• Q1B — Photostability Testing
• Q2(R1) — Analytical Validation
• Q3C — Residual Solvents
• Q5 — Quality of Biotechnological Products

Correct Answer: Q1B — Photostability Testing

Q4. Which ICH guideline details validation characteristics such as specificity, accuracy, precision, linearity, range, LOD and LOQ?

• Q1E — Evaluation of Stability Data
• Q2(R1) — Analytical Validation
• Q6A — Specifications: Test Procedures and Acceptance Criteria
• Q9 — Quality Risk Management

Correct Answer: Q2(R1) — Analytical Validation

Q5. Which guideline deals with impurities in new drug substances and gives thresholds for reporting, identification and qualification?

• Q3A(R2) — Impurities in New Drug Substances
• Q3B(R2) — Impurities in Drug Products
• Q3C — Residual Solvents
• Q3D — Elemental Impurities

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

Q6. Which ICH guideline is concerned specifically with residual solvents and their classification and permitted daily exposures?

• Q3C(R6) — Impurities: Residual Solvents
• Q3D — Elemental Impurities
• Q5C — Viral Safety Evaluation
• Q7 — GMP for APIs

Correct Answer: Q3C(R6) — Impurities: Residual Solvents

Q7. Which guideline establishes Good Manufacturing Practice (GMP) principles specifically for the manufacture of active pharmaceutical ingredients (APIs)?

• Q8(R2) — Pharmaceutical Development
• Q7 — Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Q10 — Pharmaceutical Quality System
• Q12 — Lifecycle Management

Correct Answer: Q7 — Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Q8. ICH Q8 is primarily focused on which topic?

• Analytical Method Validation
• Pharmaceutical Development and Quality by Design concepts
• Stability data evaluation
• Specifications for biological products

Correct Answer: Pharmaceutical Development and Quality by Design concepts

Q9. Which guideline gives a systematic approach to assess, control and communicate risk to quality throughout the product lifecycle?

• Q9 — Quality Risk Management
• Q10 — Pharmaceutical Quality System
• Q11 — Development and Manufacture of Drug Substances
• Q12 — Lifecycle Management

Correct Answer: Q9 — Quality Risk Management

Q10. ICH Q10 defines a Pharmaceutical Quality System (PQS). Which of the following is a primary objective of Q10?

• To mandate specific testing methods for all products
• To establish a model for an effective quality management system that supports lifecycle processes
• To harmonize clinical endpoint definitions
• To set pricing policies for marketed drugs

Correct Answer: To establish a model for an effective quality management system that supports lifecycle processes

Q11. Which guideline specifically addresses quality considerations for biotechnological/biological products?

• Q5 — Quality of Biotechnological Products
• Q6A — Specifications: Test Procedures and Acceptance Criteria for New Drug Substances
• Q3B — Impurities in Drug Products
• Q1F — Stability Guidance for Biotechnological/ Biological Products

Correct Answer: Q5 — Quality of Biotechnological Products

Q12. Which guideline provides recommendations for setting acceptance criteria and tests for small-molecule drug substances and drug products?

• Q6A — Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and Products
• Q6B — Specifications for Biotechnological Products
• Q2(R1) — Analytical Validation
• Q9 — Quality Risk Management

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

Q13. Which ICH guideline focuses on effective management of post-approval changes and lifecycle regulatory strategies?

• Q11 — Development and Manufacture of Drug Substances
• Q12 — Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
• Q8 — Pharmaceutical Development
• Q10 — Pharmaceutical Quality System

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

Q14. Under Q2(R1), which of the following is NOT considered a typical validation characteristic for an analytical procedure?

• Specificity
• Toxicity
• Limit of Detection (LOD)
• Precision

Correct Answer: Toxicity

Q15. ICH Q3D deals primarily with which type of impurities?

• Genotoxic impurities
• Residual solvents
• Elemental (metal) impurities
• Degradation products

Correct Answer: Elemental (metal) impurities

Q16. Which document should be consulted for defining climatic zones and storage conditions for stability studies?

• Q1A(R2) — Stability Testing
• Q1B — Photostability Testing
• Q3C — Residual Solvents
• Q7 — GMP for APIs

Correct Answer: Q1A(R2) — Stability Testing

Q17. Which guideline describes the classification of elemental impurities into Class 1, 2A, 2B and 3 based on toxicity, occurrence and control?

• Q3C — Residual Solvents
• Q3D — Elemental Impurities
• Q5 — Quality of Biotechnological Products
• Q6A — Specifications

Correct Answer: Q3D — Elemental Impurities

Q18. Which guideline addresses the special considerations for setting specifications and test methods for biotechnological/biological products?

• Q6B — Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
• Q6A — Specifications for Small Molecules
• Q2(R1) — Analytical Validation
• Q8 — Pharmaceutical Development

Correct Answer: Q6B — Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

Q19. Which guideline provides recommendations for the development and manufacture of pharmaceutical drug substances, including design space concepts for chemical entities?

• Q11 — Development and Manufacture of Drug Substances
• Q7 — GMP for APIs
• Q10 — Pharmaceutical Quality System
• Q3A — Impurities in New Drug Substances

Correct Answer: Q11 — Development and Manufacture of Drug Substances

Q20. In the Common Technical Document (CTD), which module primarily contains the ICH Q-series quality documentation (e.g., stability, specifications, manufacturing)?

• Module 1 — Administrative information
• Module 2 — Summaries and Overviews
• Module 3 — Quality (pharmaceutical documentation)
• Module 5 — Clinical Study Reports

Correct Answer: Module 3 — Quality (pharmaceutical documentation)

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