WHO GMP requirements MCQs With Answer

Introduction: This quiz set focuses on WHO Good Manufacturing Practices (GMP) requirements tailored for M.Pharm students pursuing Quality Management Systems (MQA 102T). The questions probe essential GMP concepts including quality systems, documentation, personnel roles, premises and equipment, contamination control, validation, change control, deviation management, and regulatory compliance. Each MCQ is designed to deepen understanding, encourage application of principles to real-world pharmaceutical manufacturing scenarios, and prepare students for examinations and professional practice. Use this set for revision, self-assessment, and to identify areas requiring further study in WHO GMP expectations for safe, effective, and quality pharmaceutical production.

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

• To minimize production costs
• To ensure the quality, safety and efficacy of pharmaceutical products
• To maximize production output
• To standardize marketing strategies

Correct Answer: To ensure the quality, safety and efficacy of pharmaceutical products

Q2. According to WHO GMP, which document is the foundation of the pharmaceutical quality system for controlling operations?

• Marketing authorization dossier
• Quality Manual
• Standard Operating Procedures (SOPs)
• Employee job descriptions

Correct Answer: Standard Operating Procedures (SOPs)

Q3. Which of the following best describes the concept of “Qualified Person” under GMP?

• A production supervisor responsible for packaging
• An authorized individual who certifies each batch for release
• An external auditor who reviews quality systems
• A supply chain manager responsible for procurement

Correct Answer: An authorized individual who certifies each batch for release

Q4. What is the most appropriate control to prevent cross-contamination in multi-product facilities?

• Using the same equipment for all products without cleaning
• Segregation of production areas, dedicated equipment or validated cleaning
• Relying solely on visual inspection of equipment
• Extending production times to allow dispersion

Correct Answer: Segregation of production areas, dedicated equipment or validated cleaning

Q5. Which GMP requirement directly addresses traceability of materials and products through production?

• Personnel training records
• Batch records and lot numbering system
• Cleaning schedules
• Facility layout diagrams

Correct Answer: Batch records and lot numbering system

Q6. What is the purpose of validation in GMP?

• To document marketing claims
• To ensure processes, equipment and methods perform consistently as intended
• To reduce the number of quality control tests
• To replace routine maintenance activities

Correct Answer: To ensure processes, equipment and methods perform consistently as intended

Q7. Which element is essential in a GMP-compliant cleaning validation program?

• Using only visual inspections
• Establishing acceptance limits, sampling methods and validated analytical procedures
• Cleaning only when equipment appears contaminated
• Outsourcing cleaning without documentation

Correct Answer: Establishing acceptance limits, sampling methods and validated analytical procedures

Q8. Under WHO GMP, how should deviations from approved procedures be managed?

• Ignored if product looks acceptable
• Recorded, investigated, risk-assessed and followed by corrective and preventive actions (CAPA)
• Reported only during annual audits
• Resolved informally by production staff without documentation

Correct Answer: Recorded, investigated, risk-assessed and followed by corrective and preventive actions (CAPA)

Q9. What is the role of quality control (QC) laboratories in GMP?

• Perform marketing research
• Conduct testing of raw materials, in-process samples and finished products to ensure compliance
• Supervise production shifts
• Manage procurement of equipment

Correct Answer: Conduct testing of raw materials, in-process samples and finished products to ensure compliance

Q10. Which of these is a critical requirement for GMP documentation?

• Documents must be handwritten only
• Documents must be clear, accurate, controlled, and retained for a defined period
• Documents can be modified without recording changes
• Only production managers need access to GMP documents

Correct Answer: Documents must be clear, accurate, controlled, and retained for a defined period

Q11. What is the significance of change control in WHO GMP?

• To permit any change without assessment
• To ensure changes are evaluated, authorized and documented to avoid negative impact on quality
• To accelerate production changes without testing
• To reduce paperwork associated with improvements

Correct Answer: To ensure changes are evaluated, authorized and documented to avoid negative impact on quality

Q12. Which of the following best describes a Quality Risk Management (QRM) approach in GMP?

• Decisions based solely on historical practice
• Systematic assessment of potential quality risks and proportionate control measures
• Random inspection scheduling
• Only financial risks are considered

Correct Answer: Systematic assessment of potential quality risks and proportionate control measures

Q13. In the context of sterile manufacturing, which GMP control is most critical to maintain product sterility?

• Non-validated aseptic techniques
• Controlled cleanroom environments, validated aseptic processes and monitoring
• Only visual cleanliness checks
• Post-production terminal cleaning without environmental monitoring

Correct Answer: Controlled cleanroom environments, validated aseptic processes and monitoring

Q14. What is the WHO GMP expectation regarding supplier qualification?

• Any supplier can be used without evaluation
• Suppliers must be qualified through assessment, audits and ongoing performance monitoring
• Qualification is optional if prices are low
• Only domestic suppliers need qualification

Correct Answer: Suppliers must be qualified through assessment, audits and ongoing performance monitoring

Q15. How should out-of-specification (OOS) results be handled according to GMP?

• Ignore and release the batch
• Investigate immediately, perform root cause analysis, and take appropriate corrective actions before release decisions
• Retest indefinitely until passing results appear
• Destroy results and retest without documentation

Correct Answer: Investigate immediately, perform root cause analysis, and take appropriate corrective actions before release decisions

Q16. Which practice contributes directly to preventing mix-ups during packaging and labeling?

• Using unsecured label stock
• Implementing clear labeling controls, line clearance procedures and barcode/automation checks
• Allowing multiple products on the same packaging line without clearance
• Relying only on operator memory for label selection

Correct Answer: Implementing clear labeling controls, line clearance procedures and barcode/automation checks

Q17. Under WHO GMP, what is required for handling and storage of raw materials?

• Store all materials together regardless of compatibility
• Appropriate identification, quarantine, controlled storage conditions and inventory controls
• Discard certificates of analysis after receipt
• Use oldest-first without verifying quality status

Correct Answer: Appropriate identification, quarantine, controlled storage conditions and inventory controls

Q18. What is the role of internal audits (self-inspections) in a GMP system?

• To replace regulatory inspections entirely
• To identify weaknesses, ensure compliance and drive continuous improvement
• To document only positive findings
• To be conducted only by external consultants

Correct Answer: To identify weaknesses, ensure compliance and drive continuous improvement

Q19. Which factor is most important when establishing a training program under WHO GMP?

• Only one-time training at hiring
• Training based on job responsibilities, documented competency assessment and periodic refreshers
• Training focused only on management
• Training without records or assessments

Correct Answer: Training based on job responsibilities, documented competency assessment and periodic refreshers

Q20. How does WHO GMP recommend handling product recalls?

• Delay recall until public relations approval
• Have a documented recall procedure enabling timely identification, retrieval and communication with health authorities
• Recall only if customers complain publicly
• Rely on distributors to manage recalls without company involvement

Correct Answer: Have a documented recall procedure enabling timely identification, retrieval and communication with health authorities

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