Regulatory compliance via quality management MCQs With Answer

Regulatory compliance via quality management MCQs With Answer

This quiz collection is designed specifically for M.Pharm students preparing for advanced topics in Quality Management Systems. It focuses on regulatory compliance through practical quality management principles including GMP, data integrity, CAPA, validation, risk management, inspections, and documentation. Each question emphasizes real-world regulatory expectations and decision-making in pharmaceutical quality systems, helping students deepen conceptual understanding and apply guidelines such as ICH, FDA and EU requirements. Answers are provided to reinforce learning and prompt further study of associated guidelines. Use these MCQs to assess readiness for exams and inspections, and to sharpen skills required for developing compliant quality systems in pharmaceutical practice.

Q1. What is the primary objective of a pharmaceutical quality management system (QMS) in regulatory compliance?

• Maximize manufacturing efficiency to reduce costs
• Ensure patient safety and consistent product quality
• Facilitate marketing and sales strategies
• Minimize number of regulatory inspections

Correct Answer: Ensure patient safety and consistent product quality

Q2. Which US regulation specifically defines current Good Manufacturing Practice (cGMP) requirements for finished pharmaceuticals?

• ICH Q9
• ISO 9001
• 21 CFR Parts 210 and 211
• ICH Q10

Correct Answer: 21 CFR Parts 210 and 211

Q3. Which sequence best describes the CAPA process in a pharmaceutical quality system?

• Containment, root cause analysis, corrective action, preventive action, effectiveness check
• Corrective action, product recall, marketing approval, documentation
• Root cause analysis, regulatory notification, product rework, release
• Risk assessment, promotional activity, training, distribution

Correct Answer: Containment, root cause analysis, corrective action, preventive action, effectiveness check

Q4. Which acronym summarizes core principles for pharmaceutical data integrity?

• GMP+
• ALCOA+
• CAPA
• FMEA

Correct Answer: ALCOA+

Q5. What are the essential stages in supplier qualification for critical raw materials?

• Initial assessment, onsite audit, qualification, ongoing monitoring
• Price negotiation, contract signing, monthly invoicing, payment
• Marketing evaluation, distribution planning, sales support, advertisement
• Short-term sampling, immediate approval, no follow-up, indefinite supply

Correct Answer: Initial assessment, onsite audit, qualification, ongoing monitoring

Q6. What is the main purpose of a formal change control system in pharmaceutical manufacturing?

• To speed up production changes without documentation
• To manage changes ensuring they do not adversely affect product quality or regulatory compliance
• To reduce headcount in quality departments
• To increase variability in processes for innovation

Correct Answer: To manage changes ensuring they do not adversely affect product quality or regulatory compliance

Q7. Which type of validation demonstrates that a manufacturing process consistently produces a product meeting predetermined specifications?

• Cleaning validation
• Analytical method validation
• Process validation
• Computerized system validation

Correct Answer: Process validation

Q8. Which guideline provides the stability testing requirements for new drug substances and products for registration?

• ICH Q7
• ICH Q1A
• ISO 9001
• GMP Annex 11

Correct Answer: ICH Q1A

Q9. Which tool is primarily used for proactive risk assessment to prioritize potential failure modes in a process?

• Fishbone diagram
• 5 Whys
• Failure Mode and Effects Analysis (FMEA)
• Batch record

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q10. Which regulation or annex specifically addresses sterile medicinal product manufacture in the European context?

• FDA Guidance on Data Integrity
• ICH Q10
• EU GMP Annex 1
• ISO 13485

Correct Answer: EU GMP Annex 1

Q11. The primary aim of Quality Risk Management as described in ICH Q9 is to:

• Eliminate the need for regulatory inspections
• Identify, analyze and control risks to the quality of the drug product
• Increase production throughput regardless of quality
• Replace the need for validation activities

Correct Answer: Identify, analyze and control risks to the quality of the drug product

Q12. What does an FDA Form 483 issued after an inspection represent?

• An immediate plant shutdown order
• A list of observations of possible violations requiring response
• A final approval to continue operations without change
• A certificate of GMP excellence

Correct Answer: A list of observations of possible violations requiring response

Q13. Which elements should a robust change control request include?

• Informal oral approval and marketing rationale only
• Risk assessment, justification, implementation plan and approval
• Only a cost estimate and proposed start date
• A list of preferred suppliers without validation

Correct Answer: Risk assessment, justification, implementation plan and approval

Q14. In the EU, who is responsible for certifying that each batch of medicinal product has been produced and checked in accordance with laws before release?

• Quality Assurance Manager
• Qualified Person (QP)
• Production Supervisor
• Regulatory Affairs Officer

Correct Answer: Qualified Person (QP)

Q15. Which of the following is NOT a typical element of an effective CAPA program?

• Root cause analysis
• Implementation of corrective actions
• Trend analysis and monitoring
• Product advertising campaigns

Correct Answer: Product advertising campaigns

Q16. The primary objective of computerised system validation (CSV) in a regulated pharmaceutical environment is to:

• Reduce capital expenditure on IT hardware
• Ensure the system is fit for intended use and maintains data integrity
• Allow unrestricted user access for flexibility
• Replace electronic records with paper records

Correct Answer: Ensure the system is fit for intended use and maintains data integrity

Q17. Which document provides the step-by-step instructions and parameters required to produce a specific pharmaceutical batch?

• Master Batch Record (MBR) or Batch Manufacturing Record
• Supplier quality agreement
• Marketing authorization dossier
• Environmental monitoring log only

Correct Answer: Master Batch Record (MBR) or Batch Manufacturing Record

Q18. For expedited reporting of serious unexpected adverse drug reactions to regulatory authorities, the typical timeline is:

• Within 30 calendar days
• Within 15 calendar days
• Within 90 calendar days
• No timeline specified

Correct Answer: Within 15 calendar days

Q19. Which type of audit is performed by an organization on itself to verify compliance with internal QMS and regulatory requirements?

• Supplier audit
• Regulatory authority inspection
• Internal audit
• External certification audit

Correct Answer: Internal audit

Q20. Which ICH guideline specifically outlines the Pharmaceutical Quality System recommended for the lifecycle of drug products?

• ICH Q8
• ICH Q9
• ICH Q10
• ICH Q11

Correct Answer: ICH Q10

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