Regulatory & Standards: OHSAS-18001 and ISO-14001, effluent management MCQs With Answer

Introduction: This quiz set focuses on Regulatory & Standards relevant to OHSAS-18001 and ISO-14001, together with effluent management concepts tailored for M.Pharm (MPC 204T Pharmaceutical Process Chemistry) students. It covers occupational health & safety management principles, environmental management systems, regulatory compliance, and practical wastewater treatment strategies used in pharmaceutical manufacturing. Questions emphasize identification of hazards and environmental aspects, management system requirements (planning, implementation, auditing), and technical effluent treatment options including biological, chemical and advanced processes. The MCQs are designed to reinforce applied knowledge required for regulatory inspections, environmental permits, process design and safe handling of active pharmaceutical ingredients and hazardous wastes in a pharmaceutical plant.

Q1. Which of the following best describes the primary objective of OHSAS 18001 as applied in a pharmaceutical manufacturing facility?

• Improving product quality through process validation
• Establishing a systematic occupational health and safety management system to eliminate hazards and reduce risks
• Ensuring environmental sustainability and emission reductions
• Specifying technical effluent treatment technologies for API removal

Correct Answer: Establishing a systematic occupational health and safety management system to eliminate hazards and reduce risks

Q2. Which sequence correctly represents the Plan-Do-Check-Act (PDCA) cycle central to ISO 14001 implementation?

• Do – Check – Plan – Act
• Plan – Do – Check – Act
• Check – Act – Do – Plan
• Act – Plan – Do – Check

Correct Answer: Plan – Do – Check – Act

Q3. Under ISO 14001:2015, identification of environmental aspects and their impacts is required under which element of the management system?

• Leadership
• Support
• Planning
• Performance evaluation

Correct Answer: Planning

Q4. Which analytical parameter is most commonly used to quantify the biodegradable organic load in pharmaceutical wastewater?

• Total Dissolved Solids (TDS)
• Biochemical Oxygen Demand (BOD)
• Heavy metals concentration
• pH

Correct Answer: Biochemical Oxygen Demand (BOD)

Q5. Which primary treatment process is most effective at destabilizing colloidal solids present in pharmaceutical effluent to allow subsequent settling?

• Activated sludge
• Coagulation and flocculation
• Granular media filtration
• Ultrafiltration

Correct Answer: Coagulation and flocculation

Q6. For persistent Active Pharmaceutical Ingredients (APIs) that are recalcitrant to biological treatment, which advanced treatment is often recommended as BAT (Best Available Technique)?

• Primary sedimentation only
• Advanced Oxidation Processes (AOPs) such as ozone/H2O2 or UV/H2O2
• Simple chlorine disinfection
• Constructed wetlands

Correct Answer: Advanced Oxidation Processes (AOPs) such as ozone/H2O2 or UV/H2O2

Q7. Which unit operation primarily achieves removal of settleable suspended solids in an effluent treatment plant (ETP)?

• Neutralization tank
• Primary clarifier (sedimentation)
• Activated carbon column
• Membrane bioreactor (MBR)

Correct Answer: Primary clarifier (sedimentation)

Q8. Typical regulatory discharge pH limits for treated industrial effluent commonly fall within which range?

• 2.0 – 4.0
• 5.5 – 9.0
• 9.5 – 11.5
• 0.5 – 3.5

Correct Answer: 5.5 – 9.0

Q9. How frequently should top management typically conduct a formal management review under OHSAS/ISO management systems?

• Daily
• Monthly
• Annually (or at planned intervals)
• Never required

Correct Answer: Annually (or at planned intervals)

Q10. Which test method or approach is used to determine Chemical Oxygen Demand (COD) in pharmaceutical effluents?

• Gas chromatography of volatile organics
• Chemical oxidation using dichromate (COD test)
• Atomic absorption for metals
• pH meter reading

Correct Answer: Chemical oxidation using dichromate (COD test)

Q11. For high-strength organic sludges generated in pharmaceutical ETPs, which stabilization method is most appropriate to reduce volatile solids and recover energy?

• Direct landfill without treatment
• Anaerobic digestion with biogas recovery
• Chlorination of sludge
• Air drying only

Correct Answer: Anaerobic digestion with biogas recovery

Q12. Under OHSAS/ISO requirements, what must an organization have to address potential emergency situations (e.g., effluent spills, chemical releases)?

• Only verbal instructions to employees
• Documented emergency preparedness and response procedures
• No specific requirement; handle as they arise
• Rely solely on local public emergency services

Correct Answer: Documented emergency preparedness and response procedures

Q13. ISO 14001:2015 introduced the requirement to consider a life-cycle perspective. What does this mean for pharmaceutical effluent management?

• Only focus on emissions at the final discharge point
• Consider environmental impacts across raw material sourcing, production, use and end-of-life
• Exclude supplier activities from consideration
• Apply life-cycle only to product packaging

Correct Answer: Consider environmental impacts across raw material sourcing, production, use and end-of-life

Q14. What is the principal objective of a Zero Liquid Discharge (ZLD) strategy in pharmaceutical industry effluent management?

• Maximize sludge disposal to landfill
• Eliminate surface water discharge by recovering and reusing all wastewater streams
• Reduce water use by 1% annually
• Only treat stormwater separately from process water

Correct Answer: Eliminate surface water discharge by recovering and reusing all wastewater streams

Q15. Which treatment configuration is typically used to achieve biological removal of nitrogen (nitrification followed by denitrification) in pharmaceutical wastewater?

• Primary coagulation tank only
• Sequencing Batch Reactor (SBR) with anoxic and aerobic phases
• Sand filtration only
• Activated carbon adsorption only

Correct Answer: Sequencing Batch Reactor (SBR) with anoxic and aerobic phases

Q16. Which BOD5/COD ratio indicates that pharmaceutical wastewater is readily biodegradable and likely amenable to conventional biological treatment?

• BOD5/COD < 0.2
• BOD5/COD ≈ 0.3
• BOD5/COD > 0.5
• BOD5/COD = 0

Correct Answer: BOD5/COD > 0.5

Q17. What term describes the legally defined maximum concentration of a chemical in workplace air to protect worker health?

• Biological Oxygen Demand (BOD)
• Occupational Exposure Limit (OEL) or Permissible Exposure Limit (PEL)
• Maximum Daily Load (MDL)
• Emission Factor (EF)

Correct Answer: Occupational Exposure Limit (OEL) or Permissible Exposure Limit (PEL)

Q18. For key operational parameters such as pH and flow in a pharmaceutical ETP, what is the recommended monitoring approach to ensure compliance and quick response?

• Manual sampling once per month
• Periodic lab tests once per quarter
• Continuous online monitoring with alarms and recording
• No monitoring required if processes are stable

Correct Answer: Continuous online monitoring with alarms and recording

Q19. What is the main purpose of maintaining an environmental aspects and impacts register in an ISO 14001 system?

• Track staff attendance
• Identify, evaluate and prioritize environmental aspects and impacts to set controls and objectives
• Record financial expenditure only
• Provide product specifications to customers

Correct Answer: Identify, evaluate and prioritize environmental aspects and impacts to set controls and objectives

Q20. According to the hierarchy of controls in occupational health & safety, which control measure is considered the most effective to reduce worker exposure to hazardous chemicals in effluent handling?

• Personal protective equipment (PPE) only
• Engineering controls such as closed transfer systems and containment
• Administrative controls like signage and limited shifts
• Elimination or substitution of the hazardous chemical where feasible

Correct Answer: Elimination or substitution of the hazardous chemical where feasible

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