WHO and EMEA GMP guidelines MCQs With Answer

WHO and EMEA GMP Guidelines MCQs With Answer

This quiz collection is designed specifically for M.Pharm students preparing for advanced examinations and professional practice in Quality Control & Quality Assurance. It focuses on key aspects of the World Health Organization (WHO) and EMEA (European) Good Manufacturing Practice (GMP) guidelines — their scope, documentary requirements, quality systems, validation, sterile manufacturing, computerized systems, qualification, change control and regulatory interactions. Each question tests conceptual understanding and application of GMP principles used in global pharmaceutical manufacturing and inspections. Use these MCQs to evaluate readiness for viva, internal assessments and to strengthen practical decision-making aligned with international GMP expectations.

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

• To reduce production costs by minimizing raw material use
• To ensure medicines are consistently produced and controlled to quality standards
• To promote marketing strategies in developing countries
• To provide recipes for formulation development

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

Q2. Which area is specifically covered by the EMEA (EU) GMP Annex 1?

• Good distribution practices for medicinal products
• Manufacture of sterile medicinal products
• Requirements for active pharmaceutical ingredients (APIs)
• Pharmacovigilance reporting procedures

Correct Answer: Manufacture of sterile medicinal products

Q3. Which WHO document series commonly contains detailed GMP guidance and annexes for vaccines and biologicals?

• WHO Technical Report Series (TRS)
• ICH Q-series Guidelines
• US Pharmacopeia General Notices
• European Pharmacopoeia Monographs

Correct Answer: WHO Technical Report Series (TRS)

Q4. Under EMEA/EU GMP, what is the role of the Qualified Person (QP)?

• To design manufacturing equipment layouts
• To certify each batch for release ensuring conformity with marketing authorization and GMP
• To perform routine maintenance on production machinery
• To market finished products in EU member states

Correct Answer: To certify each batch for release ensuring conformity with marketing authorization and GMP

Q5. Which system is emphasized by both WHO and EMEA guidelines for identifying, investigating and preventing quality failures?

• Advertising and promotional controls
• Change control only
• Corrective and Preventive Action (CAPA) system
• Sales forecasting system

Correct Answer: Corrective and Preventive Action (CAPA) system

Q6. According to EMEA/EU GMP, which document should describe the manufacturing processes, controls and site-specific arrangements for a product?

• Facility Maintenance Log
• Site Master File (SMF)
• Employee Training Matrix
• Market Authorization Application Summary

Correct Answer: Site Master File (SMF)

Q7. WHO GMP requires validation of critical processes. Which of the following best defines process validation?

• Testing every produced batch thoroughly to release it
• Establishing documented evidence that a process consistently produces a product meeting its predetermined specifications and quality attributes
• Performing equipment calibration only once a year
• Documenting raw material suppliers’ financial status

Correct Answer: Establishing documented evidence that a process consistently produces a product meeting its predetermined specifications and quality attributes

Q8. EMEA guidance on computerized systems (Annex 11) emphasizes which key requirement?

• Computer systems need no user access controls if paper backups exist
• Computerized systems must be validated, with security, audit trails and data integrity maintained
• All software must be open-source
• Validation can be omitted for legacy systems

Correct Answer: Computerized systems must be validated, with security, audit trails and data integrity maintained

Q9. Which practice is a WHO GMP expectation for documents and records?

• Oral approvals are acceptable if witnessed
• Documentation must be legible, attributable, contemporaneous and retained for a defined period
• Only final certificates need to be retained
• Records should be destroyed monthly to save space

Correct Answer: Documentation must be legible, attributable, contemporaneous and retained for a defined period

Q10. For contamination control in sterile manufacturing, WHO and EMEA recommend which of the following environmental approaches?

• Use of open windows for natural ventilation
• Defined cleanroom classifications, air-flow patterns, HEPA filtration and monitoring
• Only surface cleaning without monitoring
• Relying solely on terminal sterilization without aseptic controls

Correct Answer: Defined cleanroom classifications, air-flow patterns, HEPA filtration and monitoring

Q11. Under WHO/EMEA GMP, what is the expectation regarding supplier qualification?

• Suppliers can be used without evaluation if they are local
• Critical suppliers must be evaluated, approved, and periodically re-evaluated with documented evidence
• Qualification is only required for active manufacturing staff
• Supplier quality is the responsibility of procurement only and need not be documented

Correct Answer: Critical suppliers must be evaluated, approved, and periodically re-evaluated with documented evidence

Q12. Which EMEA guidance deals specifically with the qualification of facilities, systems and equipment?

• Annex 16 – Certified Batch Release
• Annex 15 – Qualification and Validation
• Annex 7 – Computerised Systems
• Annex 3 – Pharmacovigilance

Correct Answer: Annex 15 – Qualification and Validation

Q13. In WHO and EMEA GMP frameworks, how should changes affecting product quality be controlled?

• Implement immediately and inform regulators yearly
• Use a formal change control process with risk assessment, documentation and approval before implementation
• Only document changes if there is an adverse event
• Changes do not require assessment if performed by experienced staff

Correct Answer: Use a formal change control process with risk assessment, documentation and approval before implementation

Q14. Which is a WHO expectation for personnel working in GMP areas?

• Minimal training is acceptable if supervised
• Comprehensive initial and ongoing training, hygiene, and assigned responsibilities with documented competency
• Training records can be verbal and informal
• Only managers require formal GMP training

Correct Answer: Comprehensive initial and ongoing training, hygiene, and assigned responsibilities with documented competency

Q15. According to EMEA guidance, what is the correct approach to handling out-of-specification (OOS) results?

• Retest until a passing result is obtained without investigation
• Initiate an immediate investigation, evaluate potential root causes, and document dispositions
• Discard the batch immediately and do not report
• Ignore if the majority of other test results pass

Correct Answer: Initiate an immediate investigation, evaluate potential root causes, and document dispositions

Q16. Which WHO/EMEA concept ensures that raw materials and containers are uniquely identifiable from receipt to use?

• Bulk blending
• Full traceability and batch coding through a robust label and inventory control system
• Ad-hoc labeling by production staff
• Using handwritten logs only

Correct Answer: Full traceability and batch coding through a robust label and inventory control system

Q17. EMEA GMP requires stability data for product shelf-life claims. Which statement is correct?

• Stability testing is optional for generics
• Stability studies must support the claimed shelf-life and storage conditions of the finished product
• Accelerated studies alone are sufficient for all claims
• Stability data can be extrapolated from API supplier certificates only

Correct Answer: Stability studies must support the claimed shelf-life and storage conditions of the finished product

Q18. Which WHO guidance principle addresses contamination risk from personnel and materials in aseptic processing?

• Marketing authorization review
• Personnel training, gowning, behavior controls and material flow design to minimize contamination risk
• Using only disposable gloves without gowning
• Relying solely on final product sterility testing

Correct Answer: Personnel training, gowning, behavior controls and material flow design to minimize contamination risk

Q19. Which EMEA requirement relates to recall arrangements for defective medicinal products?

• Recalls are optional and left to marketing teams
• Manufacturers must have documented recall procedures with clear responsibilities and traceability to withdraw batches rapidly
• Only wholesalers must maintain recall procedures
• Recall procedures are only necessary for narcotics

Correct Answer: Manufacturers must have documented recall procedures with clear responsibilities and traceability to withdraw batches rapidly

Q20. For active pharmaceutical ingredient (API) GMP, which WHO expectation is correct?

• API manufacturers are exempt from GMP if the finished product manufacturer has GMP
• API manufacturers must apply GMP appropriate to the stage of manufacture and ensure quality by design and documentation
• Only finished dose forms require validation and GMP
• APIs can be qualified solely by supplier reputation without audit

Correct Answer: API manufacturers must apply GMP appropriate to the stage of manufacture and ensure quality by design and documentation

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