Bioprocessing of GMP MCQs With Answer

Bioprocessing of GMP MCQs With Answer

This collection of multiple-choice questions is designed specifically for M.Pharm students studying Bioprocess Engineering and Technology, focusing on Good Manufacturing Practice (GMP) aspects of bioprocessing. The quiz covers critical topics such as facility classification, aseptic processing, sterilization, validation (IQ/OQ/PQ), environmental monitoring, filtration, viral clearance, single-use systems, and documentation. Questions emphasize practical decision-making, regulatory expectations, and scientific rationale behind GMP controls used in biologics manufacture. Use these MCQs to test understanding, prepare for exams, and identify areas needing deeper study; each question includes one clear correct answer to support efficient revision and self-assessment.

Q1. What is the primary objective of Good Manufacturing Practice (GMP) in bioprocessing?

• Maximize production yield regardless of product quality
• Ensure products are consistently produced and controlled to the quality standards appropriate for their intended use
• Minimize manufacturing costs by reducing documentation
• Accelerate time to market by bypassing validation

Correct Answer: Ensure products are consistently produced and controlled to the quality standards appropriate for their intended use

Q2. Which EU GMP grade describes the local zone for aseptic filling where the product and container are exposed?

• Grade B
• Grade C
• Grade A
• Grade D

Correct Answer: Grade A

Q3. What is the primary use of clean steam in biopharmaceutical manufacturing?

• Heating HVAC air in production areas
• Sterilization of product-contact equipment and heat-sensitive sterilization applications where condensate quality is critical
• Cleaning floors and non-product-contact surfaces
• Providing process condensate for formulation

Correct Answer: Sterilization of product-contact equipment and heat-sensitive sterilization applications where condensate quality is critical

Q4. Which method is traditionally accepted for generating Water for Injection (WFI) to meet pharmacopeial standards?

• Ion exchange alone
• Reverse osmosis alone
• Distillation
• Autoclaving potable water

Correct Answer: Distillation

Q5. What pore size is typically specified for sterilizing-grade filters used for terminal filtration of aqueous drug products?

• 0.45 micrometer
• 0.22 micrometer
• 1.2 micrometer
• 5.0 micrometer

Correct Answer: 0.22 micrometer

Q6. In equipment qualification terminology, what does PQ stand for?

• Performance Qualification
• Process Quality
• Product Qualification
• Preliminary Qualification

Correct Answer: Performance Qualification

Q7. Which biological indicator organism is most commonly used to validate steam sterilization (autoclave) cycles?

• Geobacillus stearothermophilus spores
• Bacillus subtilis vegetative cells
• Escherichia coli
• Staphylococcus aureus

Correct Answer: Geobacillus stearothermophilus spores

Q8. Which assay is the standard for detecting bacterial endotoxin in parenteral biologic products?

• Plate count
• Limulus Amebocyte Lysate (LAL) assay
• Western blot
• Gram staining

Correct Answer: Limulus Amebocyte Lysate (LAL) assay

Q9. Which of the following is NOT a commonly applied viral clearance strategy during bioprocessing?

• Low pH viral inactivation
• Nanofiltration to remove viruses
• Chromatographic partitioning/removal
• Autoclaving the final sterile biological drug product

Correct Answer: Autoclaving the final sterile biological drug product

Q10. Which is a key advantage of adopting single-use (disposable) systems in biologics manufacturing?

• Complete elimination of all extractables and leachables
• Reduced need for cleaning and cleaning validation
• Unlimited reuse without qualification
• No requirement for supplier quality controls

Correct Answer: Reduced need for cleaning and cleaning validation

Q11. What is the primary purpose of maintaining positive pressure in an ISO-classified cleanroom?

• Prevent ingress of contaminated air from adjacent less-clean areas
• Reduce energy consumption of HVAC
• Increase humidity control accuracy
• Facilitate waste removal

Correct Answer: Prevent ingress of contaminated air from adjacent less-clean areas

Q12. Which element is essential in a GMP batch manufacturing record?

• Operator signatures indicating review and approval
• Only the planned steps without actual execution records
• Supplier internal audit reports only
• Marketing strategies for the product

Correct Answer: Operator signatures indicating review and approval

Q13. Which test is considered the best integrated assessment of aseptic processing performance?

• Endotoxin testing of final product
• Aseptic process simulation (media fill)
• Routine environmental monitoring plate counts
• Surface ATP swab testing

Correct Answer: Aseptic process simulation (media fill)

Q14. Which integrity test is commonly used to verify a sterilizing-grade membrane filter after use?

• Bubble point test
• UV-visible spectroscopy
• Gram staining of the filter surface
• Endotoxin spike recovery

Correct Answer: Bubble point test

Q15. What is the main purpose of cleaning validation in GMP bioprocessing?

• To prove the cleaning process consistently removes residues and reduces cross-contamination to predetermined acceptable levels
• To document that cleaning occurs only once per month
• To avoid the need for equipment maintenance
• To permit reuse of single-use components

Correct Answer: To prove the cleaning process consistently removes residues and reduces cross-contamination to predetermined acceptable levels

Q16. Which microorganism is most indicative of human skin contamination in a cleanroom environment?

• Pseudomonas aeruginosa
• Bacillus subtilis
• Staphylococcus epidermidis
• Clostridium difficile

Correct Answer: Staphylococcus epidermidis

Q17. Which sterilization method is preferred for heat-stable aqueous pharmaceutical solutions?

• Dry heat sterilization
• Gamma irradiation
• Moist heat (autoclave) sterilization
• Ethylene oxide sterilization

Correct Answer: Moist heat (autoclave) sterilization

Q18. What is the primary goal of implementing Process Analytical Technology (PAT) in bioprocessing?

• Replace all laboratory testing with manual inspection
• Enable real-time monitoring and control of critical process parameters to ensure consistent product quality
• Reduce the need for process understanding
• Increase batch-to-batch variability

Correct Answer: Enable real-time monitoring and control of critical process parameters to ensure consistent product quality

Q19. Which manufacturing change is most likely to be classified as a major change requiring regulatory notification?

• Change in secondary packaging artwork color
• Change in the manufacturing site for the drug substance
• Correction of a typographical error in a SOP
• Changing courier service for non-critical documents

Correct Answer: Change in the manufacturing site for the drug substance

Q20. Which containment approach provides the highest reduction in operator-product interaction and contamination risk for aseptic processing?

• Unidirectional laminar airflow bench
• Restricted Access Barrier System (RABS)
• Isolator (closed aseptic isolator)
• Open cleanroom with HEPA ceiling

Correct Answer: Isolator (closed aseptic isolator)

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