Philosophies of quality management in pharmaceuticals MCQs With Answer

Introduction: Quality management in pharmaceuticals integrates principles like GMP, QMS, QbD, TQM, validation and risk management to ensure safe, effective medicines. For B. Pharm students, understanding philosophies—such as continuous improvement, prevention over inspection, science- and risk-based decision making, and regulatory frameworks (ICH, ISO)—is essential for drug development, manufacturing, and release. Core topics include quality assurance vs quality control, process validation, analytical quality, CAPA, supplier qualification, and documentation. Grasping these concepts builds a quality culture and supports patient safety, regulatory compliance, and robust pharmaceutical systems. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which philosophy emphasizes preventing defects by designing quality into processes rather than inspecting final products?

• Quality Control
• Inspection-Based Quality
• Quality by Design (QbD)
• End-of-Line Testing

Correct Answer: Quality by Design (QbD)

Q2. Which guideline specifically focuses on pharmaceutical quality systems and lifecycle management?

• ICH Q9
• ICH Q10
• ISO 9001
• FDA 21 CFR Part 11

Correct Answer: ICH Q10

Q3. Total Quality Management (TQM) primarily advocates which of the following?

• Top-down inspections only
• Employee involvement and continuous improvement
• Batch rejection as default
• Outsourcing all quality activities

Correct Answer: Employee involvement and continuous improvement

Q4. Which tool is commonly used in pharmaceutical quality management for process improvement and reducing variability?

• Design of Experiments (DoE)
• Random Sampling without analysis
• Visual inspection only
• Uncontrolled change implementation

Correct Answer: Design of Experiments (DoE)

Q5. What does CAPA stand for in pharmaceutical quality systems?

• Corrective and Preventive Actions
• Calibration and Performance Assessment
• Compliance and Product Approval
• Control and Process Audit

Correct Answer: Corrective and Preventive Actions

Q6. Which concept uses statistical methods to monitor and control manufacturing processes?

• Good Laboratory Practice (GLP)
• Statistical Process Control (SPC)
• Good Distribution Practice (GDP)
• Batch Release by Visual Check

Correct Answer: Statistical Process Control (SPC)

Q7. Which ICH guideline deals primarily with pharmaceutical risk management?

• ICH Q8
• ICH Q9
• ICH Q10
• ICH Q7

Correct Answer: ICH Q9

Q8. Which quality philosophy prioritizes meeting customer (patient and regulator) requirements as the primary objective?

• Regulatory Evasion
• Customer-focused Quality
• Supplier-first Quality
• Production-speed Priority

Correct Answer: Customer-focused Quality

Q9. What is the primary aim of Good Manufacturing Practices (GMP)?

• Minimize production costs regardless of quality
• Ensure products are consistently produced and controlled to quality standards
• Replace quality systems with end-product testing
• Permit undocumented process changes

Correct Answer: Ensure products are consistently produced and controlled to quality standards

Q10. Process Analytical Technology (PAT) is best described as:

• A regulatory paperwork standard
• Real-time monitoring and control of critical process parameters
• Final product visual inspection protocol
• A supplier selection criterion only

Correct Answer: Real-time monitoring and control of critical process parameters

Q11. In quality management, what are CQAs?

• Critical Quality Attributes
• Commercial Quality Assessments
• Continuous Quality Actions
• Customer Query Archives

Correct Answer: Critical Quality Attributes

Q12. Which is a fundamental principle of Quality Risk Management?

• Decisions based on opinion only
• Science- and risk-based decision making
• Ignoring likelihood when assessing risk
• Treating all risks as equal

Correct Answer: Science- and risk-based decision making

Q13. Validation of a pharmaceutical process demonstrates what?

• The process consistently produces a product meeting predetermined specifications
• That the product tastes acceptable
• That documentation exists only
• That no controls are necessary

Correct Answer: The process consistently produces a product meeting predetermined specifications

Q14. Which document defines roles, responsibilities, and procedures in a QMS?

• Batch Manufacturing Record
• Quality Manual
• Purchase Order
• Marketing Plan

Correct Answer: Quality Manual

Q15. Supplier qualification primarily aims to ensure what?

• Lowest possible price regardless of quality
• Consistent quality and supply of raw materials and components
• That suppliers remain anonymous
• That suppliers handle final product release

Correct Answer: Consistent quality and supply of raw materials and components

Q16. Which approach involves iterative Plan-Do-Check-Act cycles for continuous improvement?

• Pareto Analysis
• PDCA Cycle
• Root Cause Only Approach
• End-of-Line Testing Strategy

Correct Answer: PDCA Cycle

Q17. What is the main focus of Quality Assurance (QA) compared to Quality Control (QC)?

• QA focuses on systems and processes; QC focuses on product testing
• QA performs only analytical tests; QC writes policies
• QA is post-market only; QC is pre-market only
• QA and QC are identical with no distinction

Correct Answer: QA focuses on systems and processes; QC focuses on product testing

Q18. Which metric assesses how well a process produces within specification limits?

• Process Capability (Cp/Cpk)
• Turnover Rate
• Number of Audits
• Marketing Share

Correct Answer: Process Capability (Cp/Cpk)

Q19. What is the primary purpose of an internal audit in a pharmaceutical company?

• To prepare marketing campaigns
• To objectively assess compliance with QA systems and identify improvements
• To replace external regulatory inspections
• To approve product pricing

Correct Answer: To objectively assess compliance with QA systems and identify improvements

Q20. Which validation type verifies that cleaning procedures remove residues effectively?

• Process Validation
• Cleaning Validation
• Analytical Method Validation
• Computer System Validation

Correct Answer: Cleaning Validation

Q21. Design of Experiments (DoE) helps to:

• Randomly change parameters without analysis
• Systematically study effects of multiple factors on outcomes
• Avoid statistical tools in development
• Replace regulatory requirements

Correct Answer: Systematically study effects of multiple factors on outcomes

Q22. Which is an essential element of effective documentation in GMP?

• Handwritten and illegible notes
• Clear, contemporaneous, and controlled records
• Destroying records after one month
• No signature requirements

Correct Answer: Clear, contemporaneous, and controlled records

Q23. What does OOS stand for and why is it important?

• Out of Stock; important for inventory only
• Out of Specification; important because it indicates product may not meet quality criteria
• On-site Sampling; important for audits
• Operational Standard; important for marketing

Correct Answer: Out of Specification; important because it indicates product may not meet quality criteria

Q24. Which philosophy treats quality as everyone’s responsibility in the organization?

• Quality Ownership Culture
• Senior Management Only Quality
• Quality by Inspection
• Supplier-only Quality

Correct Answer: Quality Ownership Culture

Q25. Why is change control important in pharmaceutical QMS?

• It allows uncontrolled rapid changes
• It assures changes are evaluated, approved, and documented to prevent quality impact
• It replaces validation activities
• It is only used for marketing material

Correct Answer: It assures changes are evaluated, approved, and documented to prevent quality impact

Q26. Which quality philosophy emphasizes reduction of variation as central to product quality?

• Six Sigma
• Ad hoc Testing
• Random Quality Sampling
• Inventory Maximization

Correct Answer: Six Sigma

Q27. What is the role of stability studies in pharmaceutical quality?

• To determine shelf life and storage conditions by monitoring quality over time
• To measure employee performance
• To replace in-process controls
• To determine market pricing

Correct Answer: To determine shelf life and storage conditions by monitoring quality over time

Q28. Which document provides approved instructions for manufacturing a specific batch?

• Master Batch Record (or Batch Manufacturing Record)
• Quality Manual
• Marketing Authorization
• Supplier Invoice

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

Q29. Process validation lifecycle includes which stages?

• Design, Qualification, Continued Process Verification
• Only final testing
• Marketing, Sales, Distribution
• Procurement and Disposal only

Correct Answer: Design, Qualification, Continued Process Verification

Q30. Which activity best supports building a strong quality culture in a pharmaceutical firm?

• Management commitment, training, open reporting and learning from errors
• Hiding deviations to meet deadlines
• Focusing solely on cost reduction
• Eliminating internal audits

Correct Answer: Management commitment, training, open reporting and learning from errors

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