Change management and re-qualification MCQs With Answer

Change management and re-qualification MCQs With Answer

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Change management and re-qualification MCQs with Answer is designed for M.Pharm students to reinforce key concepts in pharmaceutical validation related to controlling changes and determining when re-qualification is needed. This resource focuses on regulatory expectations, risk-based impact assessment, documentation practices, and practical triggers for re-validation of equipment, utilities, processes and computerized systems. The questions emphasize root-cause analysis, acceptance criteria, qualification stages (IQ/OQ/PQ), and examples of changes that may or may not require re-qualification. Use these MCQs to test understanding, prepare for exams, and apply principles of robust change control and lifecycle management in regulated pharmaceutical environments.

Q1. What is the primary objective of a formal change control process in pharmaceutical validation?

  • To minimize paperwork associated with changes
  • To manage and document changes to ensure product quality and regulatory compliance
  • To speed up manufacturing by allowing rapid untracked changes
  • To outsource validation activities to vendors

Correct Answer: To manage and document changes to ensure product quality and regulatory compliance

Q2. Which of the following is NOT typically considered a trigger for re-qualification of equipment?

  • Major mechanical modification to the equipment
  • Relocation of equipment to a different room with altered utilities
  • Routine preventive maintenance performed as scheduled
  • Change in critical process parameter causing different stress on equipment

Correct Answer: Routine preventive maintenance performed as scheduled

Q3. In change management, the best practice to assess the potential impact of a proposed change is to perform:

  • An arbitrary decision by the production supervisor
  • A formal risk assessment using tools such as FMEA or HACCP principles
  • A survey of operators for opinions
  • An immediate implementation followed by retrospective review

Correct Answer: A formal risk assessment using tools such as FMEA or HACCP principles

Q4. Which validation lifecycle document should describe policies for change control and re-qualification frequency?

  • Batch production record
  • Validation Master Plan (VMP)
  • Purchase order
  • Marketing authorization dossier

Correct Answer: Validation Master Plan (VMP)

Q5. Which type of change requires prospective validation before commercial use?

  • Non-critical cosmetic change to documentation
  • Change that affects a critical quality attribute or critical process parameter
  • Minor change in vendor address
  • Change in stationery supplier

Correct Answer: Change that affects a critical quality attribute or critical process parameter

Q6. After a corrective action for an out-of-specification (OOS) result, re-validation is most commonly driven by:

  • The cost of the corrective action
  • The potential impact of the root cause on product quality and process performance
  • The availability of validation staff
  • The desire to avoid documenting changes

Correct Answer: The potential impact of the root cause on product quality and process performance

Q7. What is the correct sequence of qualification activities for newly installed equipment?

  • PQ → OQ → IQ
  • IQ → PQ → OQ
  • IQ → OQ → PQ
  • OQ → IQ → PQ

Correct Answer: IQ → OQ → PQ

Q8. Which documentation should be updated as part of implementing a validated change?

  • Only the change request form
  • All affected controlled documents including SOPs, validation protocols, and drawings
  • Only training records
  • No documentation is required if the change is small

Correct Answer: All affected controlled documents including SOPs, validation protocols, and drawings

Q9. For a computerised system change, which activity is essential before re-deployment?

  • Only a speed test by IT
  • Risk assessment, impact analysis, change control, and appropriate re-validation/testing
  • Informal verbal approval from a supervisor
  • Deletion of user access controls

Correct Answer: Risk assessment, impact analysis, change control, and appropriate re-validation/testing

Q10. Periodic re-qualification of utilities (e.g., HVAC, purified water) is primarily intended to:

  • Generate additional reports for auditors
  • Verify continued performance against original acceptance criteria and detect drift
  • Delay corrective maintenance
  • Replace preventive maintenance tasks

Correct Answer: Verify continued performance against original acceptance criteria and detect drift

Q11. Which of the following changes would most likely be handled as a minor change with documentation but without re-qualification?

  • Change of a heating element in a reactor that alters temperature uniformity
  • Replacement of a non-critical, like-for-like instrument cable at the same location
  • Relocating the tablet compression line to another cleanroom
  • Change in formulation excipient supplier affecting impurity profile

Correct Answer: Replacement of a non-critical, like-for-like instrument cable at the same location

Q12. Which regulator guidance specifically emphasizes lifecycle approach to validation and managing changes?

  • ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  • ICH Q10 – Pharmaceutical Quality System
  • WHO GMP Annex 7
  • None of the above

Correct Answer: ICH Q10 – Pharmaceutical Quality System

Q13. Re-qualification after equipment relocation should include which of the following steps at minimum?

  • Only visual inspection
  • IQ, appropriate OQ tests addressing utilities and environmental differences, and PQ if process is affected
  • Only updating the equipment tag
  • Skip qualification if the relocation is within the same building

Correct Answer: IQ, appropriate OQ tests addressing utilities and environmental differences, and PQ if process is affected

Q14. Which tool is commonly used to prioritize validation activities and decide if a change requires re-validation?

  • FMEA (Failure Modes and Effects Analysis)
  • Random sampling of documents
  • Opinion polls among staff
  • Marketing analysis

Correct Answer: FMEA (Failure Modes and Effects Analysis)

Q15. When a supplier changes a component material, the change control evaluation should include:

  • Only a price comparison
  • Assessment of supplier change notification, material specification, impact on critical quality attributes, and need for testing/re-validation
  • Immediate switch without documentation
  • Stopping production permanently

Correct Answer: Assessment of supplier change notification, material specification, impact on critical quality attributes, and need for testing/re-validation

Q16. Which acceptance criterion principle should guide re-qualification test limits after a change?

  • Arbitrary tighter limits to avoid future failures
  • Limits based on validated process capability, scientific justification, and regulatory expectations
  • Use of the broadest possible limits to pass tests easily
  • No criteria are required if tests are performed

Correct Answer: Limits based on validated process capability, scientific justification, and regulatory expectations

Q17. A retrospective change control approach is acceptable when:

  • Change could significantly affect product quality
  • Change is low-risk, well-documented, and within documented policy allowing retrospective evaluation
  • There is no time to perform any assessment
  • When the change involves critical process parameters

Correct Answer: Change is low-risk, well-documented, and within documented policy allowing retrospective evaluation

Q18. Which of the following best describes “re-validation” in the context of pharmaceutical processes?

  • Re-running full commercial batches for marketing purposes
  • Executing a set of planned activities to demonstrate that a process or system remains in a state of control after a change or over time
  • Deleting old validation records
  • Only re-training operators

Correct Answer: Executing a set of planned activities to demonstrate that a process or system remains in a state of control after a change or over time

Q19. When is a partial re-qualification generally appropriate?

  • When the change affects only certain functions or subsystems and a full re-qualification is not justified by risk assessment
  • When management wants to save money regardless of risk
  • When the entire facility has been rebuilt
  • Always, irrespective of change impact

Correct Answer: When the change affects only certain functions or subsystems and a full re-qualification is not justified by risk assessment

Q20. Which activity supports evidence that re-qualification is not required after a change?

  • An opinionated email from production staff
  • Documented impact assessment, risk analysis, historical performance data, and justification in change control record
  • Immediate implementation with no documentation
  • Only a phone call to the supplier

Correct Answer: Documented impact assessment, risk analysis, historical performance data, and justification in change control record

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