Change management and change control MCQs With Answer

Introduction
Change management and change control are essential components of pharmaceutical quality systems that ensure product quality, patient safety, and regulatory compliance during organisational, process, and technical changes. This quiz collection for M.Pharm students focuses on principles, regulatory expectations, documentation, risk-based assessments, and practical workflows used to evaluate, authorize, implement, and review changes in manufacturing, quality control, and computerized systems. Questions emphasize real-world scenarios—when to use Management of Change (MOC), how to assess impact on validated processes, notification requirements, handling emergency changes, and post-implementation effectiveness checks. Use these MCQs to test conceptual understanding and to prepare for exams and practical quality system responsibilities in the pharmaceutical industry.

Q1. What is the primary difference between “change control” and “change management” in a pharmaceutical quality system?

• Change control is the technical assessment of a change while change management is the broader organisational process addressing people, processes, and communication
• Change control only applies to suppliers and change management only applies to manufacturing
• Change control is informal and change management is always documented
• There is no difference; the terms are interchangeable

Correct Answer: Change control is the technical assessment of a change while change management is the broader organisational process addressing people, processes, and communication

Q2. Which document typically initiates a formal change control process in a GMP environment?

• Risk Assessment Matrix
• Change Control Request (or Request for Change)
• Certificate of Analysis
• Deviation Report

Correct Answer: Change Control Request (or Request for Change)

Q3. During change evaluation, which activity is most important to determine regulatory impact?

• Reviewing the site organogram
• Assessing the change against product dossiers and marketing authorisations
• Counting the number of affected operators
• Checking the company holiday calendar

Correct Answer: Assessing the change against product dossiers and marketing authorisations

Q4. What is the purpose of a risk assessment within change control?

• To prioritise employee training schedules
• To quantify the financial cost only
• To evaluate potential impact on product quality, patient safety, and regulatory compliance
• To decide promotional strategies for a new product

Correct Answer: To evaluate potential impact on product quality, patient safety, and regulatory compliance

Q5. Which type of change generally requires re-evaluation of process validation?

• Change in office stationery vendor
• Minor change in lighting in office corridors
• Change in critical process parameter or manufacturing equipment
• Change in employee cafeteria menu

Correct Answer: Change in critical process parameter or manufacturing equipment

Q6. What is an “emergency change” and how should it be handled?

• A change made for convenience that requires no documentation
• A change implemented immediately to prevent harm, documented and retrospectively reviewed via the change control process
• A change that only affects marketing materials and needs no review
• A permanent change that bypasses risk assessment

Correct Answer: A change implemented immediately to prevent harm, documented and retrospectively reviewed via the change control process

Q7. Which metric is most useful to evaluate effectiveness after implementing a change?

• Number of emails exchanged during the change
• Post-implementation monitoring results such as stability, defect rates, or deviation frequency
• Total headcount of the quality unit
• Time of day when the change was approved

Correct Answer: Post-implementation monitoring results such as stability, defect rates, or deviation frequency

Q8. In computerized systems (CSV), what key activity must accompany a change to software that affects GMP functionality?

• Rename the software file
• Perform impact assessment, change control, re-validation or regression testing and update user requirements
• Change the monitor resolution
• Only update user training records without testing

Correct Answer: Perform impact assessment, change control, re-validation or regression testing and update user requirements

Q9. Which regulatory expectation relates to supplier-initiated changes?

• Supplier changes do not need any notification
• Suppliers must provide timely notifications; the site must assess impact on quality and regulatory submissions
• Only price changes need assessment
• Supplier changes can be accepted without documentation if samples look good

Correct Answer: Suppliers must provide timely notifications; the site must assess impact on quality and regulatory submissions

Q10. How should a change affecting a validated sterile process be categorised?

• Always as low risk
• As a high-risk change requiring revalidation and a thorough impact assessment
• As a marketing issue
• As unrelated to quality

Correct Answer: As a high-risk change requiring revalidation and a thorough impact assessment

Q11. Which of the following is NOT typically part of a change control SOP?

• Steps for initiation, assessment, approval, implementation, and review of changes
• Criteria for emergency changes and documentation requirements
• Procedures for disposing of obsolete personal belongings
• Roles and responsibilities, and linking to validation and risk assessment

Correct Answer: Procedures for disposing of obsolete personal belongings

Q12. When a change may impact several products, what is the best practice?

• Implement the change for one product and ignore others
• Perform a cross-product impact assessment and coordinate regulatory submissions as needed
• Delay assessment until a regulatory inspection occurs
• Inform only the production staff

Correct Answer: Perform a cross-product impact assessment and coordinate regulatory submissions as needed

Q13. Which tool is commonly used to prioritise change-related risks?

• Random number generator
• Failure Mode and Effects Analysis (FMEA)
• Product marketing scorecard
• Annual holiday plan

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q14. What is the relationship between CAPA and change control?

• CAPA and change control are independent and should never be linked
• CAPA actions that change processes must be managed through change control to ensure proper implementation and documentation
• CAPA only addresses marketing issues
• Change control replaces CAPA entirely

Correct Answer: CAPA actions that change processes must be managed through change control to ensure proper implementation and documentation

Q15. Which document must be updated if a validated master batch record is changed?

• Employee personal files only
• Master batch record, validation documentation, training records and possibly regulatory dossiers
• Only the company brochure
• No documents need updating

Correct Answer: Master batch record, validation documentation, training records and possibly regulatory dossiers

Q16. What is “baseline” in the context of change control and validation?

• A random dataset unrelated to processes
• The documented state of a system/process at a defined point used as reference for future changes
• The financial baseline for budgeting
• The calendar date of the next audit

Correct Answer: The documented state of a system/process at a defined point used as reference for future changes

Q17. Which factor should be considered when deciding if a change requires regulatory notification?

• Whether the change will affect lab coffee quality
• The potential impact on critical quality attributes, safety, efficacy, and existing marketing authorisation conditions
• The number of signatures on the change form
• The weather forecast for the implementation day

Correct Answer: The potential impact on critical quality attributes, safety, efficacy, and existing marketing authorisation conditions

Q18. Who should be involved in the change assessment team for a production process change?

• Only the person requesting the change
• Multidisciplinary representatives such as production, QC, QA, engineering, validation, and regulatory affairs
• Only external consultants
• Only human resources

Correct Answer: Multidisciplinary representatives such as production, QC, QA, engineering, validation, and regulatory affairs

Q19. For sustained compliance, how often should the change control system itself be reviewed for effectiveness?

• Never; once implemented it is permanent
• Periodically (e.g., annually) and after significant events to ensure timeliness, quality of assessments, and closure rates
• Only when a new CEO is appointed
• Only when mandated by suppliers

Correct Answer: Periodically (e.g., annually) and after significant events to ensure timeliness, quality of assessments, and closure rates

Q20. Which action demonstrates good practice after implementing a major change?

• Assuming success and not monitoring outcomes
• Conducting defined post-implementation monitoring, reviewing performance data, and documenting effectiveness
• Removing the change control record immediately
• Only informing the finance department

Correct Answer: Conducting defined post-implementation monitoring, reviewing performance data, and documenting effectiveness

Download