Regulations governing biological product manufacturing MCQs With Answer

Regulations governing biological product manufacturing MCQs With Answer is a focused quiz collection tailored for M.Pharm students in Bioprocess Engineering and Technology. These questions delve into regulatory frameworks and practical compliance topics essential for biologicals — including cGMP, ICH guidelines, biosimilar and biologics dossier requirements (IND, BLA, MAA, CTD), validation strategies, aseptic processing, viral safety, and post-marketing surveillance. Each MCQ is crafted to deepen conceptual understanding and application skills needed for regulatory submissions, quality assurance, and inspection readiness. Use this set to assess and reinforce knowledge required for industry roles, regulatory examinations, and safe, compliant manufacturing of biologic products.

Q1. Which regulatory document provides the common technical format for marketing authorization applications in the EU and many other regions?

• ICH Q9 Quality Risk Management
• CTD (Common Technical Document)
• GMP Annex 1
• WHO Good Regulatory Practices

Correct Answer: CTD (Common Technical Document)

Q2. For viral safety of a biotherapeutic produced in mammalian cells, which of the following is considered a critical control element?

• Finished product sterility testing only
• Use of validated viral inactivation and removal steps
• Endotoxin testing of raw materials
• Environmental monitoring of the warehouse

Correct Answer: Use of validated viral inactivation and removal steps

Q3. Which ICH guideline specifically addresses quality risk management principles that should be applied in biological manufacturing?

• ICH Q5C
• ICH Q7
• ICH Q9
• ICH Q10

Correct Answer: ICH Q9

Q4. During an inspection, what is the primary purpose of the batch manufacturing record for a biological product?

• To list all suppliers used in the facility
• To provide a detailed, traceable record of the production and control of that specific batch
• To serve as the marketing authorization dossier
• To record training schedules of staff

Correct Answer: To provide a detailed, traceable record of the production and control of that specific batch

Q5. Which regulatory submission is typically required in the US to initiate clinical trials for a new biological product?

• BLA (Biologics License Application)
• IND (Investigational New Drug application)
• MAA (Marketing Authorization Application)
• DMF (Drug Master File)

Correct Answer: IND (Investigational New Drug application)

Q6. What is the main focus of ICH Q5A guidance relevant to biological products?

• Good Manufacturing Practices
• Viral safety evaluation of biotechnology-derived products
• Stability testing protocols
• Pharmacovigilance reporting timelines

Correct Answer: Viral safety evaluation of biotechnology-derived products

Q7. Which of the following best describes “comparability” in the context of changes to a biological manufacturing process?

• A legal requirement to notify marketing authorities of any supplier change
• A scientific assessment demonstrating that pre- and post-change products are equivalent in quality, safety, and efficacy
• An internal audit procedure for batch records
• A stability testing protocol for cold chain

Correct Answer: A scientific assessment demonstrating that pre- and post-change products are equivalent in quality, safety, and efficacy

Q8. Annex 1 of GMP (sterile medicinal products) was updated to emphasize which of the following modern concepts?

• Elimination of environmental monitoring
• Increased reliance on process simulation and aseptic process simulations (media fills)
• Removal of personnel gowning requirements
• Reduced documentation for cleaning procedures

Correct Answer: Increased reliance on process simulation and aseptic process simulations (media fills)

Q9. Which validation activity specifically demonstrates that an analytical method is suitable for its intended purpose in biological product testing?

• Process validation
• Method validation
• Equipment qualification
• Facility qualification

Correct Answer: Method validation

Q10. For a biosimilar product approval, which concept is central to regulatory assessment?

• Exact molecular identity with the reference product
• Demonstration of high similarity through analytical, preclinical and clinical data
• Only clinical efficacy trials without analytical comparison
• Use of identical cell bank as the reference product

Correct Answer: Demonstration of high similarity through analytical, preclinical and clinical data

Q11. What is the purpose of a Master Cell Bank (MCB) in biologic manufacturing?

• To store finished product for distribution
• To provide a characterized, tested source of production cells for consistent manufacturing
• To record batch release test results
• To serve as environmental monitoring controls

Correct Answer: To provide a characterized, tested source of production cells for consistent manufacturing

Q12. Which of the following is a critical aspect of cleaning validation for equipment used in biological product manufacturing?

• Demonstrating removal of active pharmaceutical ingredient residues, cleaning agents, and microbial/pyrogenic contaminants to defined acceptance criteria
• Only checking visual cleanliness of equipment
• Running production without documented SOPs
• Sterility testing of cleaning personnel

Correct Answer: Demonstrating removal of active pharmaceutical ingredient residues, cleaning agents, and microbial/pyrogenic contaminants to defined acceptance criteria

Q13. Which regulatory concept requires manufacturers to proactively assess and manage risks to product quality throughout the product lifecycle?

• Good Clinical Practice (GCP)
• Quality Risk Management (QRM)
• Labeling requirements
• Advertising regulations

Correct Answer: Quality Risk Management (QRM)

Q14. In-process controls during biological manufacturing are primarily used to:

• Replace final release testing
• Monitor critical process parameters and ensure consistency during production
• Determine marketing strategy
• Evaluate staff performance only

Correct Answer: Monitor critical process parameters and ensure consistency during production

Q15. What is the main regulatory purpose of a Pharmacovigilance System Master File (PSMF) for biologics?

• To document manufacturing site floor plans
• To provide a comprehensive description of the pharmacovigilance system ensuring continued safety monitoring of the product
• To list excipients used in the product
• To detail clinical trial protocols only

Correct Answer: To provide a comprehensive description of the pharmacovigilance system ensuring continued safety monitoring of the product

Q16. Which guideline addresses stability testing and shelf-life assignment for biopharmaceuticals in the context of regulatory submissions?

• ICH Q1A(R2) Stability Testing of New Drug Substances and Products
• ICH Q3A Impurities in New Drug Substances
• ICH Q6A Specifications
• ICH E6 Good Clinical Practice

Correct Answer: ICH Q1A(R2) Stability Testing of New Drug Substances and Products

Q17. Which of the following is a primary inspection focus for regulators at a biological manufacturing facility?

• Marketing budgets
• Adherence to cGMP, including documentation, validation, and deviation handling
• Color of employee uniforms
• Social media presence of the company

Correct Answer: Adherence to cGMP, including documentation, validation, and deviation handling

Q18. What is the main regulatory requirement related to endotoxin testing for injectable biologics?

• Endotoxin testing is optional if sterility is proven
• Endotoxin limits must be established and endotoxin testing performed on appropriate materials and final product
• Endotoxin testing applies only to oral products
• Endotoxin levels are not relevant for recombinant proteins

Correct Answer: Endotoxin limits must be established and endotoxin testing performed on appropriate materials and final product

Q19. In process analytical technology (PAT) as encouraged by regulators, the primary benefit is to:

• Replace validated analytical methods entirely
• Enable real-time monitoring and control of critical quality attributes to ensure consistent product quality
• Reduce regulatory oversight
• Provide only historical batch data

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

Q20. Which documentation is essential to demonstrate that sterile filling operations produce aseptic drug products under controlled conditions?

• Marketing authorization letter
• Media fill (aseptic process simulation) records and environmental monitoring data
• Sales forecasts
• Supplier promotional materials

Correct Answer: Media fill (aseptic process simulation) records and environmental monitoring data

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