Introduction to Good Manufacturing Practices (GMP) MCQs With Answer

Introduction to Good Manufacturing Practices (GMP) MCQs With Answer

Good Manufacturing Practices (GMP) are the backbone of safe pharmaceutical manufacturing, ensuring product quality, patient safety, and regulatory compliance. This introduction covers core GMP concepts relevant to B. Pharm students, including quality assurance, batch records, documentation, validation, equipment qualification (IQ/OQ/PQ), contamination control, aseptic processing, cleaning validation, change control, and regulatory expectations from agencies like FDA, WHO and EMA. Understanding GMP principles—such as hygiene, sampling, stability testing, and CAPA—prepares you for industry roles in production, quality control and regulatory affairs. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary objective of Good Manufacturing Practices (GMP)?

• To ensure pharmaceutical products are consistently produced and controlled according to quality standards
• To maximize production speed regardless of quality
• To focus only on marketing and distribution
• To reduce documentation and record keeping

Correct Answer: To ensure pharmaceutical products are consistently produced and controlled according to quality standards

Q2. Which regulatory agency enforces cGMP in the United States?

• World Health Organization (WHO)
• European Medicines Agency (EMA)
• Food and Drug Administration (FDA)
• International Council for Harmonisation (ICH)

Correct Answer: Food and Drug Administration (FDA)

Q3. In the term “cGMP,” what does the “c” stand for?

• Controlled
• Current
• Certified
• Complete

Correct Answer: Current

Q4. Which document provides the stepwise manufacturing instructions for a specific product batch?

• Standard Operating Procedure (SOP)
• Master Production Record (MPR)
• Validation Protocol
• Change Control Form

Correct Answer: Master Production Record (MPR)

Q5. Which activity is primarily a Quality Control (QC) function?

• Approving SOPs
• Conducting analytical testing of raw materials
• Scheduling employee training
• Issuing change control approvals

Correct Answer: Conducting analytical testing of raw materials

Q6. What is the main purpose of cleaning validation?

• To prove cleaning removes residues and prevents cross-contamination consistently
• To validate personnel training effectiveness
• To confirm label integrity
• To calibrate laboratory instruments

Correct Answer: To prove cleaning removes residues and prevents cross-contamination consistently

Q7. Which sequence correctly represents equipment qualification stages?

• PQ → IQ → OQ
• IQ → OQ → PQ
• OQ → PQ → IQ
• Calibration → Validation → Qualification

Correct Answer: IQ → OQ → PQ

Q8. GMP requires written procedures for which of the following?

• Only analytical testing
• All critical manufacturing and quality-related operations
• Only manufacturing operations, not documentation
• Only shipping and distribution

Correct Answer: All critical manufacturing and quality-related operations

Q9. Who is primarily responsible for formal batch release in many regulatory systems?

• Production supervisor
• Quality Control analyst
• Qualified Person (QP) or Quality Assurance
• Packaging operator

Correct Answer: Qualified Person (QP) or Quality Assurance

Q10. Environmental monitoring in aseptic areas primarily tracks what?

• Chemical impurities in product
• Airborne and surface microbial contamination
• Raw material supplier performance
• Labeling accuracy

Correct Answer: Airborne and surface microbial contamination

Q11. Which GMP documentation principle is widely quoted in the pharmaceutical industry?

• If it is convenient, it is valid
• If it is not handwritten, it is invalid
• If it is not written, it did not happen
• If it is verbal, it is sufficient

Correct Answer: If it is not written, it did not happen

Q12. What is the purpose of stability testing under GMP?

• To determine manufacturing yield
• To establish product shelf life and storage conditions
• To validate cleaning procedures
• To verify personnel qualifications

Correct Answer: To establish product shelf life and storage conditions

Q13. Which control measure is essential for personnel in sterile manufacturing?

• Use of casual clothing
• Strict garbing procedures and aseptic technique training
• Limiting documentation
• Reducing hand hygiene steps

Correct Answer: Strict garbing procedures and aseptic technique training

Q14. What is the primary goal of change control in GMP?

• To speed up production changes without documentation
• To manage and assess quality impact of changes systematically
• To eliminate regulatory inspections
• To reduce testing requirements

Correct Answer: To manage and assess quality impact of changes systematically

Q15. What does CAPA stand for in GMP systems?

• Corrective and Preventive Action
• Control and Process Assessment
• Calibration and Performance Audit
• Cleaning and Personal Actions

Correct Answer: Corrective and Preventive Action

Q16. Which international standard classifies cleanrooms by airborne particle concentration?

• ISO 9001
• ISO 14644
• ICH Q7
• Good Distribution Practice (GDP)

Correct Answer: ISO 14644

Q17. Sterility testing is intended to detect which of the following?

• Chemical degradation products
• Viable microorganisms in the product
• Incorrect labeling
• Particle size distribution

Correct Answer: Viable microorganisms in the product

Q18. Which disinfectant is considered sporicidal and often used in GMP areas for spore control?

• Isopropyl alcohol
• Sodium hypochlorite (bleach)
• Buffered saline
• Distilled water

Correct Answer: Sodium hypochlorite (bleach)

Q19. Which organization issues international GMP guidance often used by many countries?

• World Health Organization (WHO)
• Federal Reserve
• World Trade Organization (WTO)
• International Monetary Fund (IMF)

Correct Answer: World Health Organization (WHO)

Q20. What is the main function of a Standard Operating Procedure (SOP)?

• To provide step-by-step instructions for consistent execution of tasks
• To replace employee training
• To act as a marketing document
• To be used only during audits

Correct Answer: To provide step-by-step instructions for consistent execution of tasks

Q21. Which qualification verifies that equipment is installed according to design specifications?

• Performance Qualification (PQ)
• Operational Qualification (OQ)
• Installation Qualification (IQ)
• Calibration Qualification (CQ)

Correct Answer: Installation Qualification (IQ)

Q22. Which record documents the actual manufacturing activities and data for each batch?

• Master Production Record
• Batch Production Record
• Change Control Log
• Validation Summary Report

Correct Answer: Batch Production Record

Q23. What does Out of Specification (OOS) refer to?

• Test results that exceed predetermined acceptance criteria
• Products that are within specification limits
• Expired documentation
• Validated manufacturing processes

Correct Answer: Test results that exceed predetermined acceptance criteria

Q24. What does “quarantine” mean for incoming raw materials?

• Immediate use in production
• Temporary hold until release by QC/QA
• Automatic rejection
• Free distribution

Correct Answer: Temporary hold until release by QC/QA

Q25. A master formula typically includes which of the following?

• List of raw materials, quantities, equipment, and process parameters
• Only packaging artwork
• Only billing information
• Only the supplier contact details

Correct Answer: List of raw materials, quantities, equipment, and process parameters

Q26. Why is personnel hygiene critical in GMP environments?

• To increase production speed
• To reduce contamination risk and protect product quality
• To reduce paperwork
• To avoid equipment calibration

Correct Answer: To reduce contamination risk and protect product quality

Q27. What is a validation protocol?

• An informal note about a process
• A predetermined plan describing how validation will be performed
• A marketing strategy
• An expired certificate

Correct Answer: A predetermined plan describing how validation will be performed

Q28. Which information is mandatory on pharmaceutical product labels under GMP?

• Batch number, expiry date, storage conditions and product name
• Only advertising slogans
• Only supplier discounts
• Only the manufacturer’s logo

Correct Answer: Batch number, expiry date, storage conditions and product name

Q29. Which test verifies the identity of a raw material?

• Assay test
• Identity test
• Dissolution test
• Sterility test

Correct Answer: Identity test

Q30. What does a Class I drug recall indicate?

• Minor labeling errors with no health risk
• Reasonable probability of serious adverse health consequences or death
• Administrative paperwork issues only
• Voluntary market withdrawal without safety concerns

Correct Answer: Reasonable probability of serious adverse health consequences or death

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com