Evolution of quality MCQs With Answer

Evolution of quality MCQs With Answer is a focused quiz collection designed for M.Pharm students studying Quality Management Systems (MQA 102T). This set covers the historical development and modern advances in pharmaceutical quality — from early statistical control and quality pioneers to current regulatory frameworks like GMP, ICH guidelines, ISO standards, QbD, PAT, and risk-based approaches. Each question tests conceptual understanding, practical application, and regulatory implications relevant to pharmaceutical manufacturing and quality assurance. Use these MCQs to reinforce classroom learning, prepare for exams, and deepen your grasp of how quality practices evolved to ensure safe, effective, and consistent drug products.

Q1. Who is often credited as the key figure who popularized modern quality management principles and is frequently called the “father of quality”?

• Walter A. Shewhart
• W. Edwards Deming
• Joseph M. Juran
• Kaoru Ishikawa

Correct Answer: W. Edwards Deming

Q2. Which pioneer introduced the concepts of Statistical Process Control (SPC) and control charts foundational to quality evolution?

• W. Edwards Deming
• Joseph M. Juran
• Walter A. Shewhart
• Philip B. Crosby

Correct Answer: Walter A. Shewhart

Q3. Which quality guru defined the “quality trilogy” of quality planning, quality control and quality improvement?

• Kaoru Ishikawa
• Joseph M. Juran
• W. Edwards Deming
• Armand V. Feigenbaum

Correct Answer: Joseph M. Juran

Q4. In which year was the first ISO 9001 quality management standard published?

• 1975
• 1987
• 1994
• 2000

Correct Answer: 1987

Q5. Which ICH guideline specifically addresses the Pharmaceutical Quality System in the evolution of pharmaceutical quality?

• ICH Q8 – Pharmaceutical Development
• ICH Q9 – Quality Risk Management
• ICH Q10 – Pharmaceutical Quality System
• ICH Q7 – Good Manufacturing Practice for APIs

Correct Answer: ICH Q10 – Pharmaceutical Quality System

Q6. What does QbD stand for in modern pharmaceutical quality paradigms?

• Quality by Design
• Quality before Distribution
• Quantitative by Default
• Quality-based Documentation

Correct Answer: Quality by Design

Q7. Six Sigma aims to limit defects to approximately how many defects per million opportunities (DPMO)?

• 66,800 DPMO
• 3.4 DPMO
• 340 DPMO
• 34,000 DPMO

Correct Answer: 3.4 DPMO

Q8. What does CAPA stand for in pharmaceutical quality management?

• Corrective and Preventive Action
• Compliance and Process Assurance
• Control and Product Analysis
• Continuous Assessment of Production Activities

Correct Answer: Corrective and Preventive Action

Q9. What is the primary objective of Good Manufacturing Practices (GMP) in the pharmaceutical industry?

• To maximize production speed regardless of quality
• To ensure products are consistently produced and controlled to quality standards
• To reduce manufacturing costs by using cheaper raw materials
• To create marketing strategies for new drug launches

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

Q10. What does PAT represent in the context of process modernization for quality evolution?

• Product Assurance Technique
• Process Analytical Technology
• Performance Assessment Tool
• Pharmaceutical Automation Technology

Correct Answer: Process Analytical Technology

Q11. Which statistical tool is most appropriate for monitoring whether a pharmaceutical manufacturing process is in statistical control?

• Pareto chart
• Control charts (Shewhart charts)
• Histogram
• Scatter plot

Correct Answer: Control charts (Shewhart charts)

Q12. Which ICH guideline focuses specifically on Quality Risk Management?

• ICH Q7 – GMP for APIs
• ICH Q8 – Pharmaceutical Development
• ICH Q9 – Quality Risk Management
• ICH Q10 – Pharmaceutical Quality System

Correct Answer: ICH Q9 – Quality Risk Management

Q13. According to modern process validation concepts, what are the three stages of process validation?

• Design Qualification, Equipment Qualification, Product Release
• Process Design, Process Qualification, Continued Process Verification
• Raw Material Testing, In-Process Testing, Final Testing
• Lab Development, Pilot Batches, Commercial Production

Correct Answer: Process Design, Process Qualification, Continued Process Verification

Q14. Which root-cause analysis tool is also called an Ishikawa diagram and is widely used in quality problem solving?

• Pareto chart
• Fishbone (Ishikawa) diagram
• Control chart
• Flowchart

Correct Answer: Fishbone (Ishikawa) diagram

Q15. The primary purpose of stability studies in pharmaceutical quality evolution is to:

• Determine manufacturing yield
• Assess patient adherence
• Establish product shelf life and storage conditions
• Evaluate marketing potential

Correct Answer: Establish product shelf life and storage conditions

Q16. PDCA cycle, a continuous improvement model in quality management, stands for:

• Plan-Do-Check-Act
• Prepare-Deliver-Check-Analyze
• Plan-Design-Create-Assess
• Predict-Do-Correct-Adapt

Correct Answer: Plan-Do-Check-Act

Q17. Lean methodology, which influenced pharmaceutical quality practices, primarily focuses on:

• Increasing inventory levels to prevent shortages
• Eliminating non-value added activities (waste)
• Strictly enforcing hierarchical decision making
• Maximizing machine downtime for maintenance

Correct Answer: Eliminating non-value added activities (waste)

Q18. Which ISO standard is specifically designed for quality management systems in medical device manufacturing?

• ISO 9001
• ISO 13485
• ISO 14001
• ISO 15189

Correct Answer: ISO 13485

Q19. Which principle best describes a fundamental requirement for validation activities in pharmaceutical quality?

• Validation must be expensive and time-consuming
• Validation must be documented, reproducible and based on scientific evidence
• Validation can be verbal if performed by experienced staff
• Validation is only necessary for new products

Correct Answer: Validation must be documented, reproducible and based on scientific evidence

Q20. ICH Q8 guideline is primarily concerned with which aspect of pharmaceutical quality evolution?

• Good Manufacturing Practice for APIs
• Pharmaceutical Development
• Pharmacovigilance
• Quality Metrics and KPIs

Correct Answer: Pharmaceutical Development

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