Production procedure for parenteral products MCQs With Answer is a focused study resource for B. Pharm students covering sterile manufacturing, aseptic processing, sterilization methods, filtration, container-closure systems, and GMP-compliant cleanroom operations. This introduction explains critical steps—raw material control, formulation, ISO-classified environment, sterilization validation (terminal sterilization vs. aseptic fill), lyophilization, in-process monitoring, and quality control tests—emphasizing validation, documentation, and contamination control. Understanding microbial limits, particulate control, environmental monitoring, and equipment qualification is essential for safe parenteral production. These MCQs reinforce core concepts, problem-solving, and regulatory expectations to prepare you for exams and industrial practice. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which sterilization method is preferred for heat-sensitive aqueous injectable formulations to achieve sterility without thermal degradation?
- Autoclaving at 121°C
- Dry heat sterilization at 160°C
- Gamma irradiation
- Sterile filtration through 0.22 μm membrane
Correct Answer: Sterile filtration through 0.22 μm membrane
Q2. What is the standard pore size of a sterilizing-grade membrane filter commonly used for terminal sterile filtration of parenteral solutions?
- 0.45 μm
- 0.22 μm
- 0.10 μm
- 1.2 μm
Correct Answer: 0.22 μm
Q3. In aseptic processing, what is the primary purpose of a media fill (process simulation) study?
- To validate chemical compatibility of vials
- To demonstrate the sterility of the final product after terminal sterilization
- To simulate production using growth media and validate aseptic technique and process controls
- To test endotoxin levels of the product
Correct Answer: To simulate production using growth media and validate aseptic technique and process controls
Q4. Which of the following is defined as the probability of a single viable microorganism occurring on a product unit after sterilization?
- D-value
- SAL (Sterility Assurance Level)
- Z-value
- F-value
Correct Answer: SAL (Sterility Assurance Level)
Q5. Which biological indicator organism is commonly used to validate steam autoclave sterilization?
- Bacillus subtilis spores
- Geobacillus stearothermophilus spores
- Clostridium botulinum spores
- Pseudomonas aeruginosa vegetative cells
Correct Answer: Geobacillus stearothermophilus spores
Q6. Which cleanroom classification corresponds to Grade A (EU GMP) for the critical zone during aseptic operations?
- ISO 8
- ISO 7
- ISO 5
- ISO 3
Correct Answer: ISO 5
Q7. What is the main advantage of terminal sterilization over aseptic filling?
- Lower equipment cost
- Lower regulatory expectations
- Higher sterility assurance due to sterilization of final sealed product
- Requires no validation
Correct Answer: Higher sterility assurance due to sterilization of final sealed product
Q8. Which test is specifically used to detect bacterial endotoxins in parenteral products?
- Sterility test (pharmaceutical)
- Macroscopic particulate test
- Limulus Amebocyte Lysate (LAL) test
- Culture-based environmental monitoring
Correct Answer: Limulus Amebocyte Lysate (LAL) test
Q9. Which water type is required for final formulation and washing of parenteral products in many pharmacopeia standards?
- Drinking water
- Purified water (PW)
- Water for Injection (WFI)
- Distilled water
Correct Answer: Water for Injection (WFI)
Q10. Which parameter is most critical to monitor in a cleanroom to control airborne particulates?
- pH of cleaning agents
- Airborne particle counts
- Color of surfaces
- Glove tensile strength
Correct Answer: Airborne particle counts
Q11. For aseptic filling, which of the following is a key function of HEPA filters in the HVAC system?
- Increase room humidity
- Remove particles ≥0.3 μm with high efficiency
- Sterilize liquids
- Heat the incoming air
Correct Answer: Remove particles ≥0.3 μm with high efficiency
Q12. Which sterilization method uses high-energy photons and is useful for prefilled syringes and single-use components but may cause material degradation?
- Dry heat sterilization
- Ethylene oxide sterilization
- Gamma irradiation
- Steam sterilization
Correct Answer: Gamma irradiation
Q13. What is the purpose of filter integrity testing (e.g., bubble point) after sterile filtration?
- To measure endotoxin level
- To confirm filter pore structure and that no breach occurred
- To assess sterility test kinetics
- To determine viscosity of the solution
Correct Answer: To confirm filter pore structure and that no breach occurred
Q14. During lyophilization (freeze-drying), which step directly removes bound water by sublimation?
- Freezing
- Primary drying
- Secondary drying
- Sealing
Correct Answer: Primary drying
Q15. In parenteral manufacturing, what is a common acceptance criterion for sterility testing using the USP sterility test?
- No turbidity observed in all test vessels after specified incubation
- pH must be neutral in growth media
- All test vessels must show turbidity
- Only one vessel may show turbidity
Correct Answer: No turbidity observed in all test vessels after specified incubation
Q16. Which of the following describes the D-value in sterilization science?
- Time required to reduce microbial population by 90% under specified conditions
- Temperature required to kill all microorganisms instantly
- Concentration of disinfectant needed for inactivation
- Pressure differential across a filter
Correct Answer: Time required to reduce microbial population by 90% under specified conditions
Q17. During sterile production, what is the main role of gowning procedures for operators?
- To identify staff by role
- To reduce operator contribution of particles and microorganisms to the critical area
- To increase production speed
- To replace cleaning validation
Correct Answer: To reduce operator contribution of particles and microorganisms to the critical area
Q18. What is the main difference between bacteriostasis and fungistasis testing in sterility assays?
- Bacteriostasis/fungistasis testing evaluates whether product inhibits growth of test organisms and could mask sterility results
- Bacteriostasis checks pH only
- Fungistasis uses different incubation temperatures only
- They are irrelevant to parenteral products
Correct Answer: Bacteriostasis/fungistasis testing evaluates whether product inhibits growth of test organisms and could mask sterility results
Q19. Which parameter is commonly validated during aseptic filling to ensure consistent fill volume and prevent contamination?
- Fill volume accuracy, container-closure integrity, and environmental controls
- Color of the product
- Employee handwriting legibility
- Packaging artwork quality
Correct Answer: Fill volume accuracy, container-closure integrity, and environmental controls
Q20. What is the typical temperature range for depyrogenation by dry heat for glassware to destroy endotoxins?
- 121°C for 15 minutes
- 160–180°C for 1–3 hours
- 60°C for 30 minutes
- 100°C for 5 minutes
Correct Answer: 160–180°C for 1–3 hours
Q21. Which of the following is NOT a primary objective of GMP in parenteral production?
- Ensuring product quality, safety, and efficacy
- Controlling contamination and maintaining documentation
- Maximizing profit at the expense of quality
- Validating processes and equipment
Correct Answer: Maximizing profit at the expense of quality
Q22. What is the primary reason multi-dose vials often include preservatives?
- To improve viscosity
- To prevent microbial growth after repeated access
- To enhance color stability
- To reduce production cost
Correct Answer: To prevent microbial growth after repeated access
Q23. Which environmental monitoring method actively samples air to count viable microorganisms?
- Settle plates (passive monitoring)
- Passive particle counters
- Active air sampling using impaction or filtration devices
- Visual inspection only
Correct Answer: Active air sampling using impaction or filtration devices
Q24. What does container-closure integrity (CCI) testing verify for sterile parenterals?
- That labels are correctly applied
- The ability of the sealed container system to maintain sterility and prevent ingress of contaminants
- The chemical potency of the drug
- Elution of extractables only
Correct Answer: The ability of the sealed container system to maintain sterility and prevent ingress of contaminants
Q25. Which critical control point is essential during sterile filtration to prevent bacterial passage through the filter?
- Using filters previously used for another drug
- Maintaining appropriate differential pressure and avoiding filter overloading
- Using oversized filter housings
- Skipping filter integrity test
Correct Answer: Maintaining appropriate differential pressure and avoiding filter overloading
Q26. Which validation demonstrates that a sterilization cycle inactivates a specific biological indicator under defined conditions?
- Process capability study
- Sterility test of the final batch only
- Biological Indicator (BI) validation and kill study
- Water system validation
Correct Answer: Biological Indicator (BI) validation and kill study
Q27. What is the main regulatory expectation when choosing terminal sterilization over aseptic processing?
- No documentation required
- Demonstration that the product retains quality and efficacy after the sterilization cycle and that validation is adequate
- Lower environmental monitoring requirements
- Shorter shelf-life without studies
Correct Answer: Demonstration that the product retains quality and efficacy after the sterilization cycle and that validation is adequate
Q28. Which of the following is an indicator of effective environmental cleaning and disinfection programs in sterile production areas?
- High variability in particle counts
- Consistently low viable and non-viable counts and trend analysis within limits
- Uncontrolled traffic flow
- Lack of cleaning records
Correct Answer: Consistently low viable and non-viable counts and trend analysis within limits
Q29. Which preservative is commonly used in some multi-dose parenteral formulations and is known for bacteriostatic activity?
- Benzyl alcohol
- Sodium chloride
- Glycerol
- Distilled water
Correct Answer: Benzyl alcohol
Q30. Which document establishes the approved manufacturing steps, parameters, and quality attributes for producing a parenteral product?
- Batch manufacturing record (BMR) and validated standard operating procedures (SOPs)
- Employee handbook
- Marketing brochure
- Invoice records
Correct Answer: Batch manufacturing record (BMR) and validated standard operating procedures (SOPs)
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