Introduction: This quiz set on Safety program elements and safety management is designed specifically for M.Pharm students to deepen their understanding of safety systems used in pharmaceutical research, development and manufacturing. It covers core concepts including hazard identification, risk assessment methods, hierarchy of controls, standard operating procedures, emergency preparedness, incident investigation and regulatory compliance. Each question emphasizes practical application in laboratory and production settings, such as process safety, permit-to-work systems, personal protective equipment and lockout/tagout procedures. Use these MCQs to test and sharpen your ability to design, evaluate and improve safety programs that protect personnel, product integrity and facility operations.
Q1. What is the primary purpose of a written safety program in a pharmaceutical facility?
- To document equipment purchase history
- To describe product marketing strategies
- To provide a structured framework to prevent injuries, control hazards and ensure regulatory compliance
- To list employee personal details
Correct Answer: To provide a structured framework to prevent injuries, control hazards and ensure regulatory compliance
Q2. Which element is essential for effective hazard identification in a laboratory?
- Annual holiday schedule
- Systematic walkthroughs, job hazard analysis and chemical safety data review
- Only relying on employee memory
- Product pricing analysis
Correct Answer: Systematic walkthroughs, job hazard analysis and chemical safety data review
Q3. In the hierarchy of controls, which control is considered most effective?
- Personal Protective Equipment (PPE)
- Administrative controls
- Elimination or substitution of the hazard
- Training and signage
Correct Answer: Elimination or substitution of the hazard
Q4. What is the main objective of a Lockout/Tagout (LOTO) procedure?
- To track chemical inventory
- To prevent accidental equipment energization during maintenance
- To label waste containers
- To authorize overtime work
Correct Answer: To prevent accidental equipment energization during maintenance
Q5. Which document provides hazard information, handling, storage and emergency measures for chemicals?
- Purchase order
- Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS)
- Employee handbook
- Maintenance log
Correct Answer: Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS)
Q6. What is a HAZOP study primarily used for in process safety management?
- Assessing financial risk of a new product
- Systematically identifying deviations from design intent and their potential causes and consequences
- Scheduling employee shifts
- Designing product packaging
Correct Answer: Systematically identifying deviations from design intent and their potential causes and consequences
Q7. Which metric measures the number of recordable incidents relative to hours worked?
- Net Promoter Score
- Total Recordable Incident Rate (TRIR)
- Gross Domestic Product
- Lead time
Correct Answer: Total Recordable Incident Rate (TRIR)
Q8. What is the key purpose of an incident investigation in a pharmaceutical setting?
- To assign blame to employees
- To identify root causes and implement corrective actions to prevent recurrence
- To increase production quotas
- To finalize product specifications
Correct Answer: To identify root causes and implement corrective actions to prevent recurrence
Q9. Which of the following is an administrative control?
- Installing isolation interlocks
- Replacing a toxic solvent with a less hazardous one
- Rotating job assignments to reduce exposure time
- Engineering a containment hood
Correct Answer: Rotating job assignments to reduce exposure time
Q10. What is a “near miss” and why is reporting it important?
- A small production defect; it is unimportant to report
- An event that could have caused harm but did not; reporting helps prevent future incidents
- A positive customer feedback; used for marketing
- An expired reagent; used for inventory write-off
Correct Answer: An event that could have caused harm but did not; reporting helps prevent future incidents
Q11. Which safety program element ensures workers are trained for specific hazards and tasks?
- Financial auditing
- Competency-based training and retraining programs
- Product labeling
- IT system backups
Correct Answer: Competency-based training and retraining programs
Q12. In risk assessment, what does the ALARP principle stand for?
- As Low As Reasonably Practicable
- Always Level All Risk Points
- As Likely As Required Procedure
- All Liability And Risk Protected
Correct Answer: As Low As Reasonably Practicable
Q13. Which control is an example of an engineering control in a lab?
- Using safety goggles
- Installing a chemical fume hood
- Providing safety training
- Posting hazard signs
Correct Answer: Installing a chemical fume hood
Q14. What role does management commitment play in an effective safety program?
- It is optional if safety committees exist
- Critical—management sets priorities, allocates resources and models safe behavior
- Only needed for financial approvals
- Limited to hiring external auditors
Correct Answer: Critical—management sets priorities, allocates resources and models safe behavior
Q15. Which element is part of an emergency response plan in a pharmaceutical plant?
- Market research timeline
- Evacuation routes, assembly points and emergency contacts
- Quality control acceptance criteria
- Supplier payment terms
Correct Answer: Evacuation routes, assembly points and emergency contacts
Q16. What is the main advantage of using a risk matrix during risk assessment?
- It predicts financial outcomes
- It helps prioritize hazards by combining likelihood and severity visually
- It replaces the need for SOPs
- It schedules maintenance tasks automatically
Correct Answer: It helps prioritize hazards by combining likelihood and severity visually
Q17. Which practice improves safety culture in a research laboratory?
- Ignoring minor safety concerns to save time
- Encouraging open reporting, leadership engagement and continuous improvement
- Penalizing all mistakes without analysis
- Restricting safety information to managers only
Correct Answer: Encouraging open reporting, leadership engagement and continuous improvement
Q18. What is the purpose of a permit-to-work system in manufacturing?
- To authorize and control hazardous work activities through formal assessment and authorization
- To record employee vacation days
- To approve marketing campaigns
- To log routine deliveries
Correct Answer: To authorize and control hazardous work activities through formal assessment and authorization
Q19. During a safety audit, which finding indicates effective implementation of safety procedures?
- Poorly maintained safety equipment with no records
- Clear documentation, evidence of training, and corrective action tracking
- No incident logs available
- Signs of repeated uncorrected hazards
Correct Answer: Clear documentation, evidence of training, and corrective action tracking
Q20. Which investigation tool focuses on underlying system failures rather than immediate human error?
- Root Cause Analysis (RCA)
- Financial audit
- Product stability testing
- Sales funnel analysis
Correct Answer: Root Cause Analysis (RCA)
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