Large-scale manufacturing of liquid dosage forms MCQs With Answer

Introduction: Large-scale manufacturing of liquid dosage forms MCQs With Answer is a focused study aid designed for M.Pharm students preparing for advanced coursework and competitive exams in Product Development and Technology Transfer. This set of multiple-choice questions delves into unit operations, formulation science, sterilization strategies, equipment selection, scale-up principles, quality control, and regulatory considerations unique to liquid dosage forms (solutions, suspensions, emulsions, parenterals, and ophthalmics). Questions emphasize practical manufacturing challenges—aseptic processing, filtration, homogenization, packaging compatibility, preservative selection, and process validation—while testing conceptual understanding required for successful technology transfer and commercial production. Use these MCQs to reinforce theory, identify weak areas, and bridge lab-scale knowledge to industrial practice.

Q1. What is the most commonly used pore size for sterilizing-grade membrane filtration of aqueous parenteral solutions?

• 0.45 µm
• 0.22 µm
• 0.1 µm
• 1.2 µm

Correct Answer: 0.22 µm

Q2. Which sterilization method is preferred for heat-labile injectable drugs when terminal sterilization is not possible?

• Autoclaving at 121°C
• Dry heat sterilization
• Aseptic processing with sterilizing filtration
• Gamma irradiation

Correct Answer: Aseptic processing with sterilizing filtration

Q3. During scale-up of a liquid mixing operation, which parameter is most often maintained to achieve similar mixing performance?

• Geometric similarity only
• Mixing time in absolute minutes
• Power input per unit volume (P/V)
• Rotational speed (rpm) of the impeller

Correct Answer: Power input per unit volume (P/V)

Q4. For oil-in-water emulsions, which HLB value of emulsifier is generally suitable to stabilize the formulation?

• 1–3
• 4–6
• 8–16
• 18–20

Correct Answer: 8–16

Q5. Which stainless steel grade is most commonly specified for pharmaceutical process equipment in large-scale liquid manufacturing?

• SS 304
• SS 316
• SS 410
• SS 201

Correct Answer: SS 316

Q6. Which test is used to detect bacterial endotoxins in parenteral products prior to release?

• Sterility test (USP)
• Limulus Amebocyte Lysate (LAL) assay
• Colony-forming unit (CFU) plate count
• Gram staining

Correct Answer: Limulus Amebocyte Lysate (LAL) assay

Q7. What is the primary purpose of conducting a filter integrity test (e.g., bubble point) after sterile filtration?

• Measure flow rate through the filter
• Confirm the filter was not damaged and maintained sterility assurance
• Determine residual contaminants in filtrate
• Assess filter chemical compatibility

Correct Answer: Confirm the filter was not damaged and maintained sterility assurance

Q8. Which closure material is most commonly used for injectable vials because of low permeability and chemical inertness?

• Natural rubber
• Bromobutyl rubber
• Synthetic latex
• Polyethylene

Correct Answer: Bromobutyl rubber

Q9. In suspension manufacture, which unit operation is primarily used to reduce particle size and obtain a narrow distribution?

• High-shear mixing
• Wet milling (e.g., media milling)
• Spray drying
• Simple stirring

Correct Answer: Wet milling (e.g., media milling)

Q10. Which environmental classification corresponds to the ISO 5 clean area commonly required for aseptic filling?

• ISO 8
• ISO 7
• ISO 5
• ISO 9

Correct Answer: ISO 5

Q11. What is the principal concern when using benzyl alcohol as a preservative in neonates?

• Allergic contact dermatitis
• Gray baby syndrome due to immature metabolism
• Loss of antimicrobial efficacy at low pH
• Incompatibility with glass containers

Correct Answer: Gray baby syndrome due to immature metabolism

Q12. Which process is typically used to remove dissolved oxygen and improve stability of oxygen-sensitive liquid products during filling?

• Steam-in-place (SIP)
• Nitrogen blanketing or sparging
• Autoclaving
• Microfiltration

Correct Answer: Nitrogen blanketing or sparging

Q13. Which analytical test is essential to quantify sub-visible particulates in injectable solutions as part of batch release?

• Viscosity measurement
• Light obscuration particle count
• pH measurement
• Content uniformity by HPLC

Correct Answer: Light obscuration particle count

Q14. During technology transfer, which document is most critical to ensure reproducibility of a liquid product at the manufacturing site?

• Sales and marketing brochure
• Master batch production record (Master formula and SOPs)
• Packaging artwork files
• Employee training certificates

Correct Answer: Master batch production record (Master formula and SOPs)

Q15. For terminal steam sterilization in an autoclave, which typical cycle condition is widely used for saturated steam sterilization?

• 121°C for 15 minutes (gravity or pre-vacuum dependent)
• 160°C for 2 hours
• 60°C for 30 minutes
• 250°C for 10 minutes

Correct Answer: 121°C for 15 minutes (gravity or pre-vacuum dependent)

Q16. Which rheological property is most important to control the physical stability and pourability of oral suspensions?

• Surface tension
• Viscosity and thixotropy
• Dielectric constant
• Boiling point

Correct Answer: Viscosity and thixotropy

Q17. What is the main rationale for performing process validation during large-scale liquid manufacturing?

• To reduce raw material costs
• To establish documented evidence that the process consistently produces a product meeting predetermined specifications
• To speed up regulatory approval without data
• To increase production throughput irrespective of quality

Correct Answer: To establish documented evidence that the process consistently produces a product meeting predetermined specifications

Q18. Which method is preferred to sterilize single-dose ophthalmic solutions that cannot withstand heat?

• Filtration through sterilizing-grade membrane (0.22 µm) followed by aseptic filling
• Autoclave at 121°C
• Dry heat sterilization
• Boiling for 30 minutes

Correct Answer: Filtration through sterilizing-grade membrane (0.22 µm) followed by aseptic filling

Q19. In scale-up, which mixing scale-up criterion is best if shear-sensitive particles must not be damaged?

• Maintain tip speed to ensure identical shear
• Maintain impeller diameter only
• Maintain power per unit volume (P/V) but reduce shear by using low-shear impellers
• Increase RPM proportionally to vessel size

Correct Answer: Maintain power per unit volume (P/V) but reduce shear by using low-shear impellers

Q20. Which regulatory test confirms absence of viable microorganisms in sterile liquid dosage forms before product release?

• Sterility test per USP (incubation for specified period)
• Viscosity test
• pH stability test
• Assay by HPLC

Correct Answer: Sterility test per USP (incubation for specified period)

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