Quality Management Systems (QMS)

1. What is the main purpose of a Quality Management System (QMS)?

a) To increase marketing expenses
b) To ensure compliance with customer and regulatory requirements
c) To improve financial performance
d) To reduce staff training costs
Answer: b

2. Which principle is foundational in developing a QMS?

a) Lowering operational costs
b) Plan-Do-Check-Act cycle
c) Focus on profit maximization
d) Centralized control
Answer: b

3. Which of the following is a benefit of implementing a QMS?

a) Increase in financial audits
b) Continuous improvement of products and services
c) Reduced customer engagement
d) Limiting staff involvement
Answer: b

4. Which ISO standard is primarily used for quality management in organizations?

a) ISO 14001
b) ISO 9001:2015
c) ISO 50001
d) ISO 31000
Answer: b

5. What does a QMS help organizations improve?

a) Profit margins
b) Customer satisfaction and process efficiency
c) Regulatory inspections
d) Marketing strategies
Answer: b

6. What is included in a QMS?

a) Financial strategies
b) Quality objectives and policies
c) Marketing and branding plans
d) Regulatory advertisements
Answer: b

7. Which of the following is NOT a typical component of a QMS?

a) Quality manual
b) Customer satisfaction analysis
c) Data management
d) Financial performance reports
Answer: d
 8. Which of the following steps is the final phase in implementing a QMS?
a) Control and measure
b) Review and improve
c) Build and deploy
d) Design
Answer: b

9. The primary goal of reviewing and improving a QMS is to:

a) Increase revenue
b) Ensure the efficiency of the process and objectives
c) Reduce compliance costs
d) Generate marketing content
Answer: b

10. Which methodology is used to ensure the continuous improvement of a QMS?

a) DMAIC
b) PDCA
c) SWOT analysis
d) Lean Six Sigma
Answer: b

Total Quality Management (TQM)

11. What is the essence of Total Quality Management (TQM)?

a) To focus solely on customer satisfaction
b) To integrate quality into the organization’s culture
c) To focus only on process improvements
d) To reduce staff involvement in decision-making
Answer: b

12. Which of these is a basic belief of TQM?

a) Customers do not play a role in quality decisions
b) Variability is beneficial to quality
c) Top management must lead the quality initiatives
d) Quality goals should remain fixed
Answer: c

13. Which of the following is NOT one of Dr. W. Edwards Deming’s 14 Points for improving
business effectiveness?
a) Break down barriers between departments
b) Cease dependence on mass inspection
c) Focus on product innovation only
d) Drive out fear
Answer: c

14. The key focus of TQM is on:

a) Reducing short-term costs
b) Achieving customer satisfaction through continuous improvement
c) Reducing market share
 d) Implementing new marketing tactics
Answer: b

15. TQM requires the involvement of which levels in the organization?

a) Top management only
b) Mid-level management only
c) All levels, from top to bottom
d) Only department heads
Answer: c

16. What is the main goal of TQM?

a) Increase production capacity
b) Achieve customer satisfaction and process excellence
c) Reduce product defects
d) Decrease workforce turnover
Answer: b

17. What is the role of statistical tools in TQM?

a) To create financial reports
b) To identify and solve quality problems
c) To control production quotas
d) To calculate profit margins
Answer: b

18. In TQM, quality improvement is driven by:

a) Customer complaints
b) Employee input and involvement
c) Marketing feedback
d) Regulatory authority recommendations
Answer: b

19. What is the focus of continuous improvement in TQM?

a) Process efficiency and error reduction
b) Increasing product pricing
c) Reducing marketing efforts
d) Streamlining regulatory documentation
Answer: a

Quality by Design (QbD)

20. What does Quality by Design (QbD) emphasize?

a) Developing random formulas for manufacturing
b) Designing products with predefined quality standards
c) Implementing market strategies after product development
d) Focus on post-production testing only
Answer: b

21. What is the Target Product Profile (TPP) in QbD?

a) A summary of the manufacturing process
b) A prediction of the drug’s market value
 c) A prospective summary of the drug’s quality characteristics
d) A financial forecast for the drug’s sales
Answer: c

22. Critical Quality Attributes (CQAs) are associated with which of the following?
a) Financial records
b) Customer demographics
c) Properties that ensure desired product quality
d) Marketing strategies
Answer: c

23. What is a Critical Process Parameter (CPP)?

a) A parameter that impacts the drug's marketability
b) A parameter whose variability impacts a critical quality attribute
c) A parameter irrelevant to the product’s quality
d) A tool for market share analysis
Answer: b

24. Which tool is used for risk assessment in QbD?

a) Financial auditing
b) FMEA (Failure Mode and Effects Analysis)
c) SWOT analysis
d) TQM
Answer: b

ISO Standards

25. What is the purpose of ISO 9000?

a) To define the environmental management system
b) To provide guidelines for quality management systems
c) To standardize drug packaging
d) To control regulatory processes
Answer: b

26. ISO 9001:2015 specifies requirements for which of the following?

a) Manufacturing processes
b) Quality management systems
c) Marketing strategies
d) Financial audits
Answer: b

27. ISO 14000 is concerned with:

a) Risk management
b) Environmental management
c) Quality control
d) Financial management
Answer: b

28. Which of the following is NOT part of ISO 14001?

a) Environmental performance evaluation
 b) Environmental management systems
c) Marketing strategies
d) Legal compliance
Answer: c

29. What does ISO 9001 certification signify for an organization?

a) Compliance with environmental standards
b) Adherence to quality management principles
c) Global marketing dominance
d) Ownership of proprietary technology
Answer: b

Six Sigma

30. What is the main objective of Six Sigma?

a) Process improvement and defect elimination
b) Minimizing customer involvement
c) Focusing on financial strategies
d) Maximizing errors for process analysis
Answer: a

31. Six Sigma uses the DMAIC methodology for which purpose?
a) To improve existing business processes
b) To define new products
c) To streamline marketing operations
d) To analyze financial records
Answer: a

32. Which of the following is part of the DMAIC methodology?

a) Define, Measure, Analyze, Improve, Control
b) Design, Manage, Analyze, Innovate, Control
c) Define, Maintain, Audit, Integrate, Control
d) Develop, Measure, Analyze, Innovate, Control
Answer: a

33. What is the target defect rate for Six Sigma processes?
a) 1 defect per 100 opportunities
b) 3.4 defects per million opportunities
c) 1 defect per 1,000 units
d) 5 defects per million opportunities
Answer: b

34. What does the DMADV methodology focus on?

a) Improving existing business processes
b) Creating new product or process designs
c) Reducing customer complaints
d) Developing new marketing strategies
Answer: b
Out of Specifications (OOS)

35. What does OOS stand for?

a) Out of specification
b) Organizational standardization
c) Operational scope
d) Out of service
Answer: a

36. Which of the following is NOT a cause of OOS?

a) Deviations in the manufacturing process
b) Errors in testing procedures
c) Malfunctioning of analytical equipment
d) Increased market demand
Answer: d

37. What is the first step when an OOS result is observed?

a) Ignore the result
b) Re-analyze the sample
c) Send the sample for marketing analysis
d) Immediately reject the product
Answer: b

38. Which of the following is part of the investigation process for OOS?
a) Re-sampling by a second analyst
b) Financial analysis of the product
c) Change in the marketing strategy
d) Product rebranding
Answer: a

Good Laboratory Practices (GLP)

39. What is the primary purpose of Good Laboratory Practices (GLP)?

a) To ensure the quality and integrity of laboratory data
b) To increase laboratory operational costs
c) To limit the availability of test data
d) To reduce regulatory compliance
Answer: a

40. Which of the following is NOT part of GLP?

a) Test facility organization
b) Quality assurance program
c) Focus on financial audits
d) Reporting of study results
Answer: c

41. Which principle of GLP emphasizes proper documentation?

a) Storage and retention of records
b) Test facility organization
c) Quality control measures
 d) Performance of the study
Answer: a

42. What is the role of the Quality Assurance Program (QAP) in GLP?
a) To monitor the marketing of the product
b) To ensure that laboratory studies are planned and performed according to GLP
c) To conduct random market surveys
d) To create promotional content
Answer: b

National Accreditation Board for Testing and Calibration Laboratories (NABL)

43. What is the purpose of NABL accreditation?

a) To certify the financial stability of a laboratory
b) To ensure technical competence in testing and calibration
c) To monitor marketing standards
d) To regulate the pricing of laboratory services
Answer: b

44. Which of the following is a benefit of NABL accreditation?

a) Increased errors in testing
b) Enhanced customer confidence and satisfaction
c) Reduced market access
d) Limited testing scope
Answer: b

45. Which field is NOT covered under NABL accreditation?

a) Biochemical testing
b) Non-destructive testing
c) Mechanical testing
d) Marketing audits
Answer: d

Change Control and Risk Management

46. What is the purpose of change control in the pharmaceutical industry?

a) To manage unapproved product changes
b) To document and evaluate proposed changes systematically
c) To prevent all product changes
d) To reduce production costs
Answer: b

47. What is typically considered a “major” change in change control?

a) Addition of a new employee
b) Modification of the formulation manufacturing process
c) Change in product packaging design
d) Adjusting marketing strategies
Answer: b
 48. What is the focus of risk assessment in pharmaceutical product development?
a) To document market trends
b) To identify risks related to formulation, process, and production
c) To develop financial budgets
d) To determine product pricing
Answer: b

ISO 9000 and ISO 14000 Series

49. What does the ISO 9000 series focus on?

a) Environmental management
b) Quality management systems
c) Energy consumption reduction
d) Marketing strategies
Answer: b

50. ISO 14001 primarily focuses on which aspect of an organization?

a) Employee performance
b) Environmental management systems
c) Quality control
d) Financial performance
Answer: b

Risk Management:

51. What does FMEA (Failure Mode Effects Analysis) help identify?
a) Financial risks in manufacturing
b) The root cause of quality defects
c) The worst-case failure scenarios and their impact
d) Supplier risk management
Answer: c

Change Control:

52. Which of the following is NOT part of the change control process?
a) Documenting the change request
b) Releasing the product immediately after a change
c) Evaluating the impact of the change
d) Gaining approval from relevant stakeholders
Answer: b

ISO 13485:

53. What is the primary purpose of ISO 13485?

a) Quality management for manufacturing
b) Standard for medical devices and related services
c) Environmental management systems
d) Energy management systems
Answer: b

Quality by Design (QbD):

 54. What does the concept of 'Design Space' in QbD refer to?
a) The range of acceptable equipment sizes in manufacturing
b) The variation in raw material suppliers
c) The multivariate combination of factors that influence product quality
d) The target market size for a product
Answer: c

CAPA (Corrective and Preventive Actions):

55. What is the first step in the CAPA process after identifying a non-conformity?
a) Implement corrective actions
b) Perform a root cause analysis
c) Notify regulatory authorities
d) Accept the non-conformance as is
Answer: b

Advanced Concepts in Risk Management

56. Which tool is most commonly used to prioritize risks in a process?

a) Pareto Chart
b) Risk Priority Number (RPN)
c) Fishbone Diagram
d) SWOT Analysis
Answer: b

57. What does a "Failure Mode" refer to in a Failure Mode Effects Analysis (FMEA)?
a) The likelihood of failure in a product's market success
b) The step in the process where failure occurs
c) The total cost of product failure
d) A preventive measure for failure
Answer: b

58. What is the role of "Hazard and Operability Analysis (HAZOP)" in risk management?
a) Analyzing financial risks in manufacturing
b) Identifying and evaluating risks in manufacturing processes
c) Defining product specifications
d) Measuring customer satisfaction
Answer: b

Change Control and Documentation

59. Which of the following is a major change that requires formal change control
documentation?
a) Change in packaging supplier
b) Change in raw material quality
c) Change in the batch size
d) Change in SOP names
Answer: b

60. What is a key component of the Change Control process?

a) Ignoring the impact of the change
b) Documenting the justification and impact analysis
 c) Reducing testing procedures
d) Approving changes without any impact review
Answer: b

61. Who typically initiates a change control request?

a) Regulatory authorities
b) Marketing department
c) The department requesting the change (e.g., production or quality control)
d) The finance department
Answer: c

62. What is a common reason for initiating a change control request?

a) Marketing department strategy changes
b) Issues with product quality or safety
c) Changes in environmental policies
d) Increasing workforce size
Answer: b

Six Sigma Methodologies

63. Which Six Sigma methodology is used when designing a new product or service?
a) DMAIC
b) DMADV
c) PDCA
d) TQM
Answer: b

64. In the DMAIC methodology, what is the primary focus of the "Measure" phase?
a) Identify defects
b) Define the project scope
c) Collect data on process performance
d) Implement changes
Answer: c

65. Which tool is used during the "Analyze" phase of DMAIC to identify root causes of defects?
a) Pareto Chart
b) Fishbone Diagram (Ishikawa)
c) Histogram
d) Control Chart
Answer: b

66. In Six Sigma, "Critical to Quality (CTQ)" refers to:

a) Customer specifications that are essential for product success
b) Financial targets for product success
c) Supplier quality metrics
d) Marketing and branding goals
Answer: a

Quality by Design (QbD) Specifics

 67. What is the significance of "Design Space" in the QbD framework?
a) It defines the optimal range of process parameters for achieving product quality
b) It defines market trends for new products
c) It specifies financial parameters for product development
d) It focuses on customer satisfaction
Answer: a

68. Which of the following is a characteristic of a Critical Quality Attribute (CQA)?

a) It is a raw material characteristic
b) It determines the shelf-life of a product
c) It ensures that the product meets the regulatory requirements
d) It defines the environmental impact of the manufacturing process
Answer: c

69. What is the role of "Risk Assessment" in QbD?

a) To predict the financial performance of the product
b) To identify potential risks that could affect the product’s quality and safety
c) To minimize the market size of the product
d) To define customer satisfaction scores
Answer: b

70. Which of the following is NOT part of the QbD approach?

a) Risk-based approach to product development
b) Focus on end-of-line testing only
c) Continuous monitoring of the manufacturing process
d) Predefined quality targets for the product
Answer: b

Out of Specifications (OOS) and Investigation

71. When an OOS result occurs, the first step is to:

a) Ignore the result
b) Notify the supervisor and initiate an investigation
c) Immediately release the product
d) Begin a recall process
Answer: b

72. Which of the following is considered an assignable cause of OOS results?

a) Errors due to improper sample preparation
b) A natural variation in the process
c) Incorrect customer expectations
d) Marketing miscommunication
Answer: a

73. After identifying an assignable cause for OOS, what is the next step?
a) Ignore the cause
b) Take corrective action and re-test
c) Increase production output
 d) Change the product design
Answer: b

74. What is the purpose of performing a root cause analysis in OOS investigations?
a) To identify the financial impact of the OOS
b) To determine whether the process can be accelerated
c) To identify the underlying cause of the deviation and prevent recurrence
d) To revise the marketing strategy
Answer: c

Good Laboratory Practices (GLP)

75. Which of the following is a principle of GLP?

a) Ignoring the need for data retention
b) Ensuring that the test facilities are adequately equipped and staffed
c) Limiting laboratory inspections
d) Focusing solely on post-production testing
Answer: b

76. Which of the following is NOT covered under GLP guidelines?

a) Test facility organization
b) Training of laboratory personnel
c) Standardization of market research
d) Reporting and retention of study results
Answer: c

77. Which GLP principle focuses on ensuring the quality and integrity of the study data?
a) Test Facility Organization
b) Performance of the Study
c) Quality Assurance Program
d) Reporting of Study Results
Answer: c

ISO 9000 and ISO 14000 Series

78. ISO 9000 helps organizations to:

a) Increase their customer base
b) Comply with quality management principles and improve quality consistency
c) Develop new market strategies
d) Reduce financial audits
Answer: b

79. Which ISO standard is most relevant for environmental management systems?
a) ISO 50001
b) ISO 9001
c) ISO 14001
d) ISO 31000
Answer: c
 80. What is the primary goal of ISO 14001?
a) To manage manufacturing processes
b) To provide guidelines for environmental management
c) To improve financial reporting
d) To enhance product innovation
Answer: b

Change Control in Pharmaceutical Manufacturing

81. What is a "major change" in change control?

a) Change in raw material quality
b) Change in administrative references
c) Change in the manufacturing site's name
d) Change in product packaging design
Answer: a

82. In a change control process, what is the primary responsibility of the Quality Assurance
(QA) team?
a) Implement the changes directly
b) Review the change request and approve it based on its impact
c) Analyze marketing strategies
d) Develop customer communication plans
Answer: b

Proficiency Testing and Accreditation

83. What does proficiency testing in laboratories help evaluate?

a) The speed of product production
b) The performance accuracy of laboratories against established standards
c) The financial stability of laboratories
d) The customer satisfaction with laboratory results
Answer: b

84. What is the main benefit of NABL accreditation?

a) Limited access to international markets
b) Enhanced trust in laboratory testing and calibration results
c) Increased product failure rates
d) Limited testing capabilities
Answer: b

DMAIC Methodology in Six Sigma

85. What is the primary focus of the "Improve" phase in DMAIC?

a) Establishing product pricing
b) Optimizing processes and removing defects
c) Marketing the new product
 d) Reviewing financial performance
Answer: b

86. Which of the following is an example of a tool used in the "Control" phase of DMAIC?
a) Scatter plot
b) Control charts
c) Risk matrices
d) Pareto analysis
Answer: b