Risk management tools – HACCP MCQs With Answer

Risk management tools – HACCP MCQs With Answer

Introduction: Hazard Analysis and Critical Control Points (HACCP) is a scientific, systematic approach for identifying, evaluating and controlling hazards that could compromise product safety. For M.Pharm students, HACCP is essential in pharmaceutical manufacturing, particularly for sterile products, aseptic processing, cleaning validation and supplier control. This set of MCQs explores HACCP principles, critical control points, decision-trees, validation, monitoring, corrective actions, documentation and integration with prerequisite programmes and other risk tools like FMEA. These questions are designed to deepen understanding of regulatory expectations, practical implementation and problem-solving required for quality assurance and patient safety in pharmaceutical operations.

Q1. What does HACCP stand for?

• Hazard Analysis and Critical Control Points
• Hazard Assessment and Condition Control Procedures
• Health Analysis and Chemical Control Program
• Hazard Assessment of Chemical and Contaminant Processes

Correct Answer: Hazard Analysis and Critical Control Points

Q2. How many basic principles of HACCP are defined by the Codex Alimentarius?

• Five
• Six
• Seven
• Eight

Correct Answer: Seven

Q3. Which of the following is defined as HACCP Principle 1 according to Codex?

• Identify critical control points (CCPs)
• Establish corrective actions
• Conduct a hazard analysis
• Establish monitoring procedures

Correct Answer: Conduct a hazard analysis

Q4. Which statement best defines a Critical Control Point (CCP)?

• A step where quality attributes are assessed for acceptability
• A step at which control can be applied to prevent, eliminate or reduce a hazard to acceptable levels
• A final inspection point before product release
• A prerequisite programme such as personnel hygiene

Correct Answer: A step at which control can be applied to prevent, eliminate or reduce a hazard to acceptable levels

Q5. Which risk assessment tool is commonly used within HACCP to decide whether a step is a CCP?

• Risk priority number (RPN)
• HACCP decision tree
• Root cause analysis fishbone diagram
• Statistical process control chart

Correct Answer: HACCP decision tree

Q6. What is a critical limit in HACCP terminology?

• An administrative target for staff training
• A measurable criterion (maximum or minimum) that separates acceptability from unacceptability at a CCP
• A suggested guideline for supplier selection
• An allocation of time for product release testing

Correct Answer: A measurable criterion (maximum or minimum) that separates acceptability from unacceptability at a CCP

Q7. Which of the following is NOT one of the Codex HACCP principles?

• Establish verification procedures
• Establish monitoring procedures
• Establish product pricing strategy
• Establish corrective actions

Correct Answer: Establish product pricing strategy

Q8. In HACCP, what does validation primarily confirm?

• That monitoring records have been completed accurately
• That the HACCP plan, including control measures, is scientifically and technically capable of controlling hazards
• That corrective actions were documented
• That training was provided to all staff

Correct Answer: That the HACCP plan, including control measures, is scientifically and technically capable of controlling hazards

Q9. Which of the following is an appropriate corrective action when monitoring shows a critical limit has been exceeded?

• Ignore the deviation if it is a single occurrence
• Segregate and evaluate affected product, identify and correct the root cause, and document actions
• Immediately change the product label
• Delay documentation until the next review

Correct Answer: Segregate and evaluate affected product, identify and correct the root cause, and document actions

Q10. What are prerequisite programmes (PRPs) in the context of HACCP?

• Programs designed only for environmental monitoring labs
• Foundation measures such as GMP, sanitation, maintenance and supplier control that support HACCP
• Marketing activities to support product launch
• Quality targets for product aesthetics

Correct Answer: Foundation measures such as GMP, sanitation, maintenance and supplier control that support HACCP

Q11. Which type of hazard in pharmaceutical HACCP would include endotoxin contamination, spore-forming bacteria or cross-contamination with microorganisms?

• Chemical hazard
• Physical hazard
• Microbiological hazard
• Allergenic hazard

Correct Answer: Microbiological hazard

Q12. When should a HACCP plan be reviewed and updated?

• Only when a regulatory inspector requests it
• Periodically and whenever there are changes to materials, process, equipment, or when new hazards are identified
• Once every ten years regardless of change
• Only after product complaints

Correct Answer: Periodically and whenever there are changes to materials, process, equipment, or when new hazards are identified

Q13. What is the primary purpose of HACCP record-keeping in pharmaceuticals?

• To provide marketing data for sales teams
• To document actions that demonstrate control of hazards, enable traceability and support regulatory inspections
• To record employee attendance
• To track inventory levels for cost analysis

Correct Answer: To document actions that demonstrate control of hazards, enable traceability and support regulatory inspections

Q14. For aseptic manufacturing HACCP teams, which expertise is MOST critical to include?

• Packaging designer only
• Microbiologist or sterility assurance specialist
• Sales representative
• Procurement clerk only

Correct Answer: Microbiologist or sterility assurance specialist

Q15. Which of the following would typically be identified as a CCP in pharmaceutical sterile product manufacturing?

• Final product packaging aesthetics check
• Sterilization cycle (e.g., autoclaving or terminal sterilization)
• Staff uniform color selection
• Office temperature control

Correct Answer: Sterilization cycle (e.g., autoclaving or terminal sterilization)

Q16. Under what circumstance would a control point NOT be classified as a CCP?

• If control at that step is critical and prevents hazards
• If no hazard exists at that step
• If control at that step cannot prevent, eliminate or reduce the hazard to acceptable levels
• If monitoring is easy to implement

Correct Answer: If control at that step cannot prevent, eliminate or reduce the hazard to acceptable levels

Q17. How does Failure Mode and Effects Analysis (FMEA) complement HACCP in pharmaceutical risk management?

• FMEA is only used after a product recall
• FMEA provides a systematic prospective evaluation of failure modes and their effects to prioritize risks and preventive actions
• FMEA replaces HACCP principles in sterile manufacturing
• FMEA is strictly a cost accounting tool

Correct Answer: FMEA provides a systematic prospective evaluation of failure modes and their effects to prioritize risks and preventive actions

Q18. Which of the following is NOT generally considered a component of HACCP monitoring systems?

• Specified monitoring frequency and methods
• Assigned responsibilities and record forms
• Corrective action triggers and documentation
• Product marketing strategy

Correct Answer: Product marketing strategy

Q19. Which Codex HACCP principle number corresponds to the establishment of documentation and record-keeping?

• Principle 3
• Principle 5
• Principle 7
• Principle 1

Correct Answer: Principle 7

Q20. What is the main objective of implementing a HACCP system in pharmaceutical manufacturing?

• To increase product sales through branding
• To prevent, eliminate or reduce hazards to an acceptable level to protect patient safety
• To minimize staff training requirements
• To extend product shelf-life regardless of safety

Correct Answer: To prevent, eliminate or reduce hazards to an acceptable level to protect patient safety

Download