WHO cGMP guidelines MCQs With Answer

Introduction: WHO cGMP guidelines MCQs With Answer is designed for M.Pharm students to deepen their understanding of the World Health Organization’s current Good Manufacturing Practices (cGMP). This collection focuses on core regulatory expectations — quality management systems, documentation, facility and equipment design, validation, personnel, risk management, and inspection readiness. Each question emphasizes practical application and regulatory nuance encountered in pharmaceutical manufacturing and quality assurance. Practicing these MCQs helps students prepare for examinations and real-world regulatory interactions by reinforcing key principles, common inspection findings, and approaches to compliance with WHO and internationally harmonized standards.

Q1. What is the primary objective of WHO cGMP guidelines?

• To maximize production output regardless of quality
• To ensure products are consistently produced and controlled to quality standards
• To standardize pricing for pharmaceutical products
• To limit international trade of active pharmaceutical ingredients

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

Q2. According to WHO cGMP, which document is considered the most critical for traceability of manufacturing activities?

• Raw material certificates of analysis
• Batch production and control records
• Supplier invoices
• Maintenance logs

Correct Answer: Batch production and control records

Q3. Which principle of WHO cGMP underpins the qualification and validation of equipment and processes?

• Good distribution practice
• Quality risk management
• Marketing authorization
• Pharmacovigilance

Correct Answer: Quality risk management

Q4. What is the correct sequence for validation lifecycle activities per WHO guidance?

• Operational qualification (OQ), Installation qualification (IQ), Performance qualification (PQ)
• IQ, OQ, PQ
• PQ, OQ, IQ
• Design qualification (DQ), PQ, IQ

Correct Answer: IQ, OQ, PQ

Q5. In WHO cGMP, which role is ultimately responsible for the quality of manufactured products?

• Quality control analyst
• Production supervisor
• Qualified person or responsible person as defined by the regulation
• Supply chain manager

Correct Answer: Qualified person or responsible person as defined by the regulation

Q6. Which document should describe the design, location, and critical attributes of cleanroom classification?

• Marketing application dossier
• Facility master file or premises layout and design specification
• Employee training records
• Sales and distribution plan

Correct Answer: Facility master file or premises layout and design specification

Q7. According to WHO cGMP, what is the key purpose of a change control system?

• To reduce the number of suppliers
• To ensure changes are evaluated, documented, and approved before implementation
• To speed up product release without documentation
• To track employee attendance

Correct Answer: To ensure changes are evaluated, documented, and approved before implementation

Q8. What is the most appropriate action when a significant deviation is detected during production?

• Continue production and report deviation at month end
• Quarantine affected materials/batches and perform investigation with root-cause analysis
• Discard the batch immediately without investigation
• Hide the deviation to avoid regulatory scrutiny

Correct Answer: Quarantine affected materials/batches and perform investigation with root-cause analysis

Q9. Which WHO cGMP concept emphasizes documented evidence that a process consistently produces a product meeting predetermined specifications?

• Production forecasting
• Validation
• Marketing surveillance
• Inventory control

Correct Answer: Validation

Q10. Under WHO guidance, what should be included in qualification of computerized systems used for GMP activities?

• Only user access controls
• Risk-based validation, functional requirements, data integrity checks, and change control
• Documentation only after system retirement
• Visual inspection of hardware only

Correct Answer: Risk-based validation, functional requirements, data integrity checks, and change control

Q11. Which of the following is a core element of quality management emphasized by WHO cGMP?

• Ad hoc decision making
• Comprehensive documentation and management review
• Outsourcing all critical activities without oversight
• Maximizing profits over product quality

Correct Answer: Comprehensive documentation and management review

Q12. What is the expectation for personnel training under WHO cGMP?

• Training only when hired and never updated
• Regular, documented training relevant to duties with effectiveness assessment
• Unrecorded oral instructions are sufficient
• Only top management requires training

Correct Answer: Regular, documented training relevant to duties with effectiveness assessment

Q13. In WHO cGMP, how should sampling and testing be performed?

• Randomly with no written procedure
• According to validated methods and documented sampling plans to ensure representativeness
• Only visual inspection is required
• Testing can be skipped if the manufacturer trusts the supplier

Correct Answer: According to validated methods and documented sampling plans to ensure representativeness

Q14. Which practice is essential for ensuring data integrity in GMP-regulated activities?

• Allowing never-to-be-changed handwritten records without controls
• Applying ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, and available
• Archiving only electronic records and discarding originals
• Using undocumented shortcuts to expedite release

Correct Answer: Applying ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, and available

Q15. Regarding suppliers and contract manufacturers, WHO cGMP requires that manufacturers should:

• Never audit suppliers
• Qualify, audit, and maintain appropriate agreements and oversight of suppliers and contractors
• Outsource all quality decisions to suppliers
• Ignore certificate of analysis from suppliers

Correct Answer: Qualify, audit, and maintain appropriate agreements and oversight of suppliers and contractors

Q16. What is the WHO expectation for stability studies supporting product shelf life?

• Stability testing is optional after product launch
• Stability studies must be designed based on stress and real-time conditions to support assigned shelf life and storage conditions
• Only accelerated testing is acceptable
• Assume stability without data if formulation looks stable

Correct Answer: Stability studies must be designed based on stress and real-time conditions to support assigned shelf life and storage conditions

Q17. Which WHO guidance principle applies when deciding on the use of reprocessed or reworked materials?

• Reprocessing without documentation is allowed
• Reprocessing or rework must be controlled, validated, and approved through formal procedures with risk assessment
• Always discard any non-conforming material without assessment
• Use reworked material only if production is behind schedule

Correct Answer: Reprocessing or rework must be controlled, validated, and approved through formal procedures with risk assessment

Q18. During a WHO GMP inspection, which record is an inspector most likely to review to assess quality oversight?

• Marketing brochures
• Deviation investigations, CAPA records, and management review minutes
• Employee personal emails
• Utility bills

Correct Answer: Deviation investigations, CAPA records, and management review minutes

Q19. How does WHO cGMP recommend handling outsourced analytical testing?

• Send samples with no contract and accept results as-is
• Use qualified laboratories under written agreements with defined specifications, method transfer, and data review
• Outsource only without any oversight from the manufacturer
• Rely solely on supplier certificates without verification

Correct Answer: Use qualified laboratories under written agreements with defined specifications, method transfer, and data review

Q20. Which WHO cGMP annex or concept specifically addresses the production of sterile medicinal products?

• Annex on packaging waste management
• Annex on sterile product manufacture including aseptic processing and sterilization validation
• Annex on marketing authorization fees
• Annex on advertising standards

Correct Answer: Annex on sterile product manufacture including aseptic processing and sterilization validation

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