Large-scale manufacturing of parenteral dosage forms MCQs With Answer

Introduction: This quiz collection focuses on large-scale manufacturing of parenteral dosage forms, tailored for M.Pharm students studying Product Development and Technology Transfer. It covers critical aspects such as aseptic processing, sterilization technologies, container-closure systems, fill–finish operations, lyophilization, environmental controls, and validation requirements. Questions are designed to test theoretical understanding and practical decision-making relevant to scale-up, process validation, contamination control, and regulatory expectations. The set emphasizes risk-based approaches, equipment selection, and process optimization to ensure sterility, product stability, and compliance during technology transfer from pilot to commercial manufacturing.

Q1. What is the primary objective of large-scale manufacturing of parenteral dosage forms?

• Maximize production speed regardless of sterility
• Ensure sterility, safety and consistent product quality
• Minimize labor costs by automating all steps
• Reduce packaging costs at the expense of stability

Correct Answer: Ensure sterility, safety and consistent product quality

Q2. Which sterilization method is most suitable for heat-sensitive protein formulations in bulk prior to aseptic filling?

• Autoclaving (moist heat)
• Dry heat sterilization
• Sterile filtration using 0.22 µm membrane filters
• Ethylene oxide gas sterilization

Correct Answer: Sterile filtration using 0.22 µm membrane filters

Q3. During technology transfer of a sterile parenteral process, which document provides the acceptance criteria and methods for demonstrating sterility assurance?

• Process Flow Diagram
• Equipment Purchase Order
• Validation Master Plan (VMP) and Sterilization/Process Validation Protocols
• Marketing Authorization Letter

Correct Answer: Validation Master Plan (VMP) and Sterilization/Process Validation Protocols

Q4. In aseptic filling, what is the main purpose of an isolator or restricted access barrier system (RABS)?

• To increase production speed by adding manual operators
• To create an enclosed, controlled environment minimizing operator intervention and contamination risk
• To replace final sterilization steps such as gamma irradiation
• To provide aesthetic packaging operations

Correct Answer: To create an enclosed, controlled environment minimizing operator intervention and contamination risk

Q5. Which environmental grade (cleanroom class) is typically required at the filling zone for aseptic parenteral operations according to EU GMP?

• Grade D
• Grade C
• Grade B (with Grade A local zone)
• ISO 9

Correct Answer: Grade B (with Grade A local zone)

Q6. Which parameter is critical when selecting a sterilizing-grade filter for final filtration of parenteral solutions?

• Filter color
• Bubble point, integrity testability and compatibility with formulation
• Price per square centimeter only
• Manufacturer logo and packaging design

Correct Answer: Bubble point, integrity testability and compatibility with formulation

Q7. Which of the following is a key risk associated with lyophilization scale-up for parenteral drug products?

• Increased visual appeal of vials
• Change in collapse temperature, cycle time and residual moisture impacting stability
• Guaranteed reduction in manufacturing cost
• Automatic elimination of need for sterility testing

Correct Answer: Change in collapse temperature, cycle time and residual moisture impacting stability

Q8. What is the purpose of a media fill (process simulation) in sterile parenteral manufacturing?

• To validate container glass quality
• To demonstrate aseptic process reproducibility and operator/environmental control using nutrient media
• To test color consistency of the final product
• To evaluate packaging artwork adherence

Correct Answer: To demonstrate aseptic process reproducibility and operator/environmental control using nutrient media

Q9. During transfer of a lyophilized injectable product to commercial scale, which of the following is most important to verify?

• That the lyophilizer door color matches the pilot unit
• Equivalence of heat and mass transfer, vial heat transfer coefficients (Kv), and cycle performance
• Only visual similarity of cake appearance
• Reduction of fill volume by 50% without data

Correct Answer: Equivalence of heat and mass transfer, vial heat transfer coefficients (Kv), and cycle performance

Q10. What is the most appropriate method to demonstrate integrity of a sterilizing filter after filtration but prior to aseptic filling?

• Visual inspection of filter housing
• Bubble point/forward flow or diffusion test (integrity testing)
• Weighing the filter
• Measuring filter diameter

Correct Answer: Bubble point/forward flow or diffusion test (integrity testing)

Q11. Which container-closure system factor is most critical for preventing microbial ingress in parenteral products?

• Color of the rubber stopper
• Seal integrity, material compatibility and extractables/leachables profile
• Shape of the vial shoulder
• Brand of packaging supplier only

Correct Answer: Seal integrity, material compatibility and extractables/leachables profile

Q12. For sterilization of prefilled syringe glass components at commercial scale, which method is commonly used if the drug product cannot tolerate terminal heat sterilization?

• Gamma irradiation of assembled filled syringes
• Sterile filtration of drug followed by aseptic assembly and filling in controlled environment
• Dry heat sterilization of final assembled product
• Washing with non-sterile water

Correct Answer: Sterile filtration of drug followed by aseptic assembly and filling in controlled environment

Q13. Which in-process control is essential during aseptic filling to detect particulate contamination risk?

• Visual inspection of operator badges only
• Real-time airborne particle monitoring, particularly in Grade A/within laminar flow zones
• Endotoxin testing of incoming water only
• Color matching of product to a standard card

Correct Answer: Real-time airborne particle monitoring, particularly in Grade A/within laminar flow zones

Q14. What is the regulatory expectation for sterilization validation of terminally sterilized parenterals?

• Validation is optional if production volume is high
• Demonstration of SAL (sterility assurance level), cycle lethality (F0/D-value), and bioburden control with documented validation
• Only visual records of autoclave loading are required
• Manufacturer’s verbal confirmation suffices

Correct Answer: Demonstration of SAL (sterility assurance level), cycle lethality (F0/D-value), and bioburden control with documented validation

Q15. What is the main reason for using depyrogenated water-for-injection (WFI) and strict water system controls in parenteral manufacturing?

• To improve taste of the injectable
• To control endotoxin levels and microbiological quality that could cause febrile reactions
• To reduce container corrosion only
• To increase conductivity for analytical testing

Correct Answer: To control endotoxin levels and microbiological quality that could cause febrile reactions

Q16. Which parameter should be monitored and controlled during aseptic filling to ensure dose uniformity for small-volume parenterals?

• Ambient room temperature only
• Filling pump accuracy, flow rate stability, and fill-volume verification
• Label adhesive strength
• Floor tile pattern

Correct Answer: Filling pump accuracy, flow rate stability, and fill-volume verification

Q17. During scale-up, how should process analytical technology (PAT) be used for parenteral manufacture?

• PAT should replace all quality control testing
• PAT should be used for real-time monitoring of critical quality attributes and process parameters to support control strategy
• PAT should monitor only operator performance
• PAT is irrelevant for sterile products

Correct Answer: PAT should be used for real-time monitoring of critical quality attributes and process parameters to support control strategy

Q18. What is a key consideration when transferring an aseptic filling process to a new facility?

• Only the color of the production floor matters
• Equivalence of environmental classification, equipment qualification, personnel training, and validated procedures to ensure reproducibility
• Immediate increase of batch sizes without validation
• Switching from glass to plastic without stability data

Correct Answer: Equivalence of environmental classification, equipment qualification, personnel training, and validated procedures to ensure reproducibility

Q19. Which test is most appropriate for assessing container-closure system integrity of sterile parenteral vials at commercial scale?

• Visual inspection only
• Deterministic integrity testing methods such as helium leak detection or vacuum decay
• Measuring the label alignment
• Weighing the empty vial and comparing to a standard

Correct Answer: Deterministic integrity testing methods such as helium leak detection or vacuum decay

Q20. In process validation for aseptic manufacture, what does process performance qualification (PPQ) demonstrate?

• That marketing materials are finalized
• That the commercial process performs reproducibly within predetermined limits across multiple consecutive commercial-scale batches
• That only one batch was successful historically
• That operator uniforms fit properly

Correct Answer: That the commercial process performs reproducibly within predetermined limits across multiple consecutive commercial-scale batches

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