Basics of pharmaceutical quality management MCQs With Answer

Basics of pharmaceutical quality management MCQs With Answer

This collection of 20 multiple-choice questions focuses on the basics of pharmaceutical quality management tailored for M.Pharm students. Each question targets core concepts from quality systems, Good Manufacturing Practices (GMP), documentation, validation, regulatory guidances (ICH Q8/Q9/Q10), quality risk management and continuous improvement. Questions are designed to test both theoretical understanding and practical application, including deviations, CAPA, change control, stability studies, supplier qualification and audit processes. Answers are provided immediately after each question to facilitate quick self-assessment and learning. Use this resource to identify knowledge gaps, prepare for examinations, and reinforce principles critical to ensuring product quality, patient safety and regulatory compliance in pharmaceutical development and manufacturing.

Q1. What is the primary difference between Quality Assurance (QA) and Quality Control (QC)?

• Quality Assurance focuses on processes and systems to prevent defects
• Quality Control focuses on testing products for defects
• Both QA and QC focus only on documentation
• QA is a regulatory authority that inspects manufacturers

Correct Answer: Quality Assurance focuses on processes and systems to prevent defects

Q2. Which ICH guideline specifically deals with Pharmaceutical Quality System (PQS) and quality lifecycle approaches?

• ICH Q8
• ICH Q9
• ICH Q10
• ICH Q11

Correct Answer: ICH Q10

Q3. In Quality Risk Management, which tool is most appropriate for assessing the priority and severity of potential failure modes?

• Process Capability Analysis
• Failure Mode and Effects Analysis (FMEA)
• Control Chart
• Pareto Chart

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q4. Which document typically describes the hierarchical structure of a pharmaceutical quality system including policies, SOPs and records?

• Master Production Schedule
• Quality Manual
• Validation Protocol
• Batch Manufacturing Record

Correct Answer: Quality Manual

Q5. Which of the following best defines “Deviation” in GMP context?

• Planned change approved through change control
• Any departure from an approved instruction, procedure, specification or standard
• Routine variance expected during normal production
• Supplier-delivered nonconforming raw material

Correct Answer: Any departure from an approved instruction, procedure, specification or standard

Q6. What is the main objective of a Corrective and Preventive Action (CAPA) system?

• To punish employees responsible for deviations
• To document all manufacturing activities
• To identify root causes of nonconformities and prevent recurrence
• To increase production speed

Correct Answer: To identify root causes of nonconformities and prevent recurrence

Q7. Which validation document provides an overarching strategy and schedule for validation activities within an organization?

• Validation Master Plan (VMP)
• Installation Qualification (IQ)
• Standard Operating Procedure (SOP)
• Analytical Method Validation Report

Correct Answer: Validation Master Plan (VMP)

Q8. Which of the following is a critical element of stability studies for marketed pharmaceutical products?

• Only accelerated testing at 60°C
• Testing under defined ICH conditions (long-term and accelerated) to establish shelf-life
• Visual inspection only
• Testing raw materials instead of finished products

Correct Answer: Testing under defined ICH conditions (long-term and accelerated) to establish shelf-life

Q9. Which metric is most commonly used to express process capability relative to specification limits?

• Standard Deviation (σ)
• Process Capability Index (Cpk)
• Mean Value
• Median

Correct Answer: Process Capability Index (Cpk)

Q10. Under GMP, which practice ensures that only authorized and trained personnel perform specified tasks?

• Change control
• Personnel qualification and training
• Batch coding
• Supplier auditing

Correct Answer: Personnel qualification and training

Q11. What is the primary purpose of change control within a pharmaceutical quality system?

• To allow unrestricted modifications to processes
• To evaluate, approve and document changes so product quality is maintained
• To replace CAPA
• To reduce documentation burden

Correct Answer: To evaluate, approve and document changes so product quality is maintained

Q12. Which type of audit is performed internally by a company to assess compliance and effectiveness of its quality system?

• Regulatory inspection
• Supplier audit
• Internal audit (self-inspection)
• Customer audit

Correct Answer: Internal audit (self-inspection)

Q13. Which document must be reviewed and approved before a new batch of a sterile product is released for distribution?

• Equipment maintenance log only
• Certificate of Analysis (CoA) and batch release documentation
• Marketing plan
• Raw material purchase order

Correct Answer: Certificate of Analysis (CoA) and batch release documentation

Q14. The term “Out of Specification (OOS)” refers to which scenario?

• When test results fall outside predefined acceptance criteria
• When a product has been shipped late
• When a document is missing a signature
• When equipment is due for calibration

Correct Answer: When test results fall outside predefined acceptance criteria

Q15. Which of the following is a key principle of Good Documentation Practices (GDP)?

• Use pencil so changes are easy
• All entries must be attributable, legible, contemporaneous, original and accurate (ALCOA)
• Backdate records to match production targets
• Keep no documentation for expired batches

Correct Answer: All entries must be attributable, legible, contemporaneous, original and accurate (ALCOA)

Q16. Which regulatory standard provides requirements for a quality management system focused on customer satisfaction and continual improvement that can be applied in pharma?

• ISO 14001
• ISO 9001
• ISO 27001
• ISO 50001

Correct Answer: ISO 9001

Q17. What is the main advantage of applying Quality by Design (QbD) principles in pharmaceutical development?

• Reduced regulatory scrutiny completely
• Better understanding of process variability and built-in quality through design
• Elimination of the need for validation
• Faster stability testing by skipping real-time studies

Correct Answer: Better understanding of process variability and built-in quality through design

Q18. Which activity is critical when qualifying a new raw material supplier?

• Accept materials without testing if price is low
• Conduct supplier assessment, audit, and incoming material testing
• Rely solely on supplier’s marketing brochure
• Only check lead-time and delivery terms

Correct Answer: Conduct supplier assessment, audit, and incoming material testing

Q19. Which statistical tool is commonly used for monitoring ongoing process stability and detecting trends or shifts?

• Histogram
• Control charts
• Scatter plot
• Box-and-whisker plot

Correct Answer: Control charts

Q20. According to ICH Q9, which of the following best describes risk acceptability judgment?

• All risks must be eliminated regardless of impact
• Risk acceptability is based on scientific knowledge, severity, probability and detectability balanced against benefits and resources
• Risk is acceptable if it reduces cost
• Risk assessment is not required for legacy products

Correct Answer: Risk acceptability is based on scientific knowledge, severity, probability and detectability balanced against benefits and resources

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