GMP and GDP requirements for biologics in India MCQs With Answer

Introduction: GMP and GDP requirements for biologics in India MCQs With Answer is designed for M.Pharm students preparing for exams in Regulatory Aspects of Herbal and Biologicals (MRA202T). This quiz set focuses on Indian regulatory expectations and international best practices for manufacturing, quality control, distribution and storage of biological products. Questions emphasize facility design, contamination control, validation, stability, cold chain management, documentation, batch release and pharmacovigilance — topics crucial for ensuring safety, potency and traceability of biologics. Practicing these MCQs will deepen understanding of regulatory frameworks (CDSCO/Schedule M/Schedule Y), GMP/GDP principles and practical quality systems needed for biologics compliance in India.

Q1. What is the primary Indian regulatory authority responsible for approving and overseeing manufacturing of biologics?

• Central Drugs Standard Control Organization (CDSCO)
• Food Safety and Standards Authority of India (FSSAI)
• Drug Controller General of India (DCGI) independent from CDSCO
• Indian Pharmacopoeia Commission (IPC)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q2. Which schedule of the Drugs and Cosmetics Rules in India specifically contains Good Manufacturing Practices applicable to pharmaceutical manufacturers, including biologics?

• Schedule D
• Schedule M
• Schedule Y
• Schedule X

Correct Answer: Schedule M

Q3. For clinical trial approval and requirements related to new biologicals in India, which regulatory document is most relevant?

• Schedule M
• Schedule Y
• Indian Pharmacopoeia
• Good Distribution Practices (GDP) Guidelines

Correct Answer: Schedule Y

Q4. Which of the following is a critical GMP requirement to prevent cross-contamination in biologics manufacturing?

• Single production room for all products to simplify cleaning
• Segregation by dedicated suites and controlled personnel flow
• Allowing open windows for natural ventilation
• Common wastewater lines without monitoring

Correct Answer: Segregation by dedicated suites and controlled personnel flow

Q5. What is the typical temperature range required for storage of many licensed vaccines and several biologics under cold chain conditions?

• -80°C to -60°C
• 2°C to 8°C
• 15°C to 25°C
• Room temperature with humidity control

Correct Answer: 2°C to 8°C

Q6. In GMP for biologics, which validation is specifically necessary to demonstrate removal or inactivation of viral contaminants?

• Cleaning validation
• Viral clearance validation
• Packaging validation
• Analytical method validation

Correct Answer: Viral clearance validation

Q7. Which environmental control component is essential in aseptic processing areas for biologics to maintain particulate and microbial control?

• HEPA filtration and controlled air classifications
• Only natural ventilation
• Open shelving for easy access
• Non-classified office air handling

Correct Answer: HEPA filtration and controlled air classifications

Q8. During GDP for biologics, what is a key requirement for transportation providers handling temperature-sensitive products?

• No requirement for temperature monitoring if transit is under 24 hours
• Temperature-controlled transport with continuous monitoring and validated packaging
• Only verbal confirmation of temperature upon receipt
• Using any courier without qualification

Correct Answer: Temperature-controlled transport with continuous monitoring and validated packaging

Q9. Which document is fundamental in GMP to provide step-by-step instructions, responsibilities and acceptance criteria for manufacturing operations?

• Master Production Record (MPR) / Batch Manufacturing Record (BMR)
• Marketing brochure
• Supplier invoice
• Personnel CV

Correct Answer: Master Production Record (MPR) / Batch Manufacturing Record (BMR)

Q10. For biologics, which quality attribute is commonly assessed by bioassay rather than simple chemical assay?

• Particle size by laser diffraction
• Potency based on biological activity
• pH measurement
• Water content by Karl Fischer

Correct Answer: Potency based on biological activity

Q11. Which Indian programme is principally responsible for adverse event monitoring and pharmacovigilance of medicines, including biologics?

• National Health Mission (NHM)
• Pharmacovigilance Programme of India (PvPI)
• Ayushman Bharat
• Indian Council of Medical Research (ICMR)

Correct Answer: Pharmacovigilance Programme of India (PvPI)

Q12. What is the purpose of stability studies for biologics according to regulatory expectations?

• To determine marketing strategy only
• To establish shelf-life, storage conditions and specification limits over time
• To assess only microbial contamination at release
• To evaluate packaging aesthetics

Correct Answer: To establish shelf-life, storage conditions and specification limits over time

Q13. In the context of GMP, what is ‘cleanroom classification’ intended to control?

• Employee salaries
• Acceptable levels of airborne particulates and microbial contamination
• Marketing claims
• Transportation routes

Correct Answer: Acceptable levels of airborne particulates and microbial contamination

Q14. Which activity is essential in GDP to ensure product traceability from manufacturer to patient?

• Random distribution without records
• Serialization, batch records and maintained distribution logs
• Only storing invoices at manufacturer end
• Destroying shipment records after 30 days

Correct Answer: Serialization, batch records and maintained distribution logs

Q15. For biologics manufacturing, what is the primary purpose of cleaning validation?

• To prove that cleaning procedures consistently remove product residues, cleaning agents and contaminants to acceptable limits
• To check machinery lubrication levels
• To test employee handwashing technique
• To validate distribution routes

Correct Answer: To prove that cleaning procedures consistently remove product residues, cleaning agents and contaminants to acceptable limits

Q16. Which of the following is a critical record retention requirement under GMP for biologics?

• Discard batch records after 6 months
• Maintain batch production records and quality control data for a period defined by regulation (commonly several years)
• Keep only electronic copies without backups
• Only retain marketing materials permanently

Correct Answer: Maintain batch production records and quality control data for a period defined by regulation (commonly several years)

Q17. What role does Quality by Design (QbD) play in biologics development under GMP principles?

• QbD is irrelevant to biologics and only applies to small molecules
• QbD promotes understanding of process and product variability to build quality into development and manufacturing
• QbD is a marketing term for faster approvals
• QbD focuses exclusively on packaging design

Correct Answer: QbD promotes understanding of process and product variability to build quality into development and manufacturing

Q18. Which practice is required under GMP for qualification of suppliers of critical raw materials for biologics?

• Rely solely on supplier catalog descriptions without audits
• Supplier qualification through audits, quality agreements and material specifications
• Purchase only from the lowest bidder without quality checks
• Accept verbal assurances of quality

Correct Answer: Supplier qualification through audits, quality agreements and material specifications

Q19. In case of a temperature excursion during transit of a vaccine, which GDP action is appropriate?

• Automatically discard the product without investigation
• Initiate an investigation, assess impact using temperature logs and stability data, and decide disposition per SOP
• Return product to sender without documentation
• Ignore if transit time was short

Correct Answer: Initiate an investigation, assess impact using temperature logs and stability data, and decide disposition per SOP

Q20. Which of the following best describes the importance of change control under GMP for biologics?

• Change control is optional and only for cosmetic changes
• Formal change control ensures systematic evaluation, approval and documentation of changes that may impact product quality, safety or efficacy
• Changes can be implemented immediately without review to save time
• Change control only applies to marketing labels

Correct Answer: Formal change control ensures systematic evaluation, approval and documentation of changes that may impact product quality, safety or efficacy

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