Introduction: Change control procedures and documentation are core elements of pharmaceutical quality systems that ensure any modification to processes, equipment, materials, or documents is assessed, authorized, implemented, and tracked under Good Manufacturing Practice (GMP). For B. Pharm students, understanding change control, SOP updates, risk assessment, validation impact, CAPA linkage, and regulatory expectations (FDA/EMA/WHO) is essential for maintaining product quality and compliance. Effective change control requires clear roles, thorough documentation, version control, impact analysis, and post-implementation verification. Mastery of these concepts strengthens quality assurance and audit readiness. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of a pharmaceutical change control procedure?
- To reduce production costs by altering formulations
- To ensure changes are assessed, approved, documented, and implemented without compromising product quality
- To allow unrestricted modifications to equipment
- To outsource decision making to external vendors
Correct Answer: To ensure changes are assessed, approved, documented, and implemented without compromising product quality
Q2. Which document typically initiates the formal process for a proposed change?
- Purchase Order
- Change Request or Change Control Form
- Batch Production Record
- Supplier Invoice
Correct Answer: Change Request or Change Control Form
Q3. Which activity is essential during initial assessment of a proposed change?
- Immediate implementation of the change
- Risk assessment to determine potential impact on quality, safety, and efficacy
- Marketing approval
- Discarding existing documentation
Correct Answer: Risk assessment to determine potential impact on quality, safety, and efficacy
Q4. Who is normally responsible for final approval of a critical GMP change?
- Line operator
- Quality Unit or Authorized Change Control Board (CCB)
- External consultant
- Temporary contractor
Correct Answer: Quality Unit or Authorized Change Control Board (CCB)
Q5. Which type of change requires revalidation or qualification in many cases?
- Change in cafeteria menu
- Change in critical process parameters, equipment, or analytical methods
- Change in office layout
- Change in company logo
Correct Answer: Change in critical process parameters, equipment, or analytical methods
Q6. What is retrospective change control?
- Change implemented without prior approval, reviewed after implementation
- Planned change approved before implementation
- Change that has no documentation
- Change that applies only to non-GMP items
Correct Answer: Change implemented without prior approval, reviewed after implementation
Q7. Which record is most important to demonstrate traceability of a document change?
- Employee salary records
- Document change history or revision log with effective dates and approvers
- Raw material COA
- Maintenance log for unrelated equipment
Correct Answer: Document change history or revision log with effective dates and approvers
Q8. How should emergency changes be managed to remain compliant?
- Implemented with no recordkeeping
- Implemented quickly with immediate documentation, justification, and expedited review
- Ignored until the next annual review
- Sent to marketing for approval
Correct Answer: Implemented quickly with immediate documentation, justification, and expedited review
Q9. What is the relationship between change control and CAPA?
- They are unrelated quality functions
- CAPA may trigger change control and change control outcomes may prompt CAPA
- Change control replaces CAPA
- CAPA is only for financial issues
Correct Answer: CAPA may trigger change control and change control outcomes may prompt CAPA
Q10. Which stakeholder should be consulted for changes affecting analytical methods?
- Human resources
- Analytical development or QC department
- Cleaning staff
- Security personnel
Correct Answer: Analytical development or QC department
Q11. What must be demonstrated during post-implementation review?
- That the change increased production speed only
- Effectiveness of the change and absence of unintended negative impacts
- That all staff liked the change
- That supply costs went up
Correct Answer: Effectiveness of the change and absence of unintended negative impacts
Q12. Which regulatory guidance emphasizes formal change control under GMP?
- Food nutrition guidelines
- ICH Q7, FDA guidance, and WHO GMP guidance
- Pest control manuals
- International accounting standards
Correct Answer: ICH Q7, FDA guidance, and WHO GMP guidance
Q13. When a supplier of a critical raw material changes, what is an essential first step?
- Continue operations without review
- Perform supplier qualification and risk/impact assessment
- Switch to a different product entirely
- Update marketing brochures
Correct Answer: Perform supplier qualification and risk/impact assessment
Q14. Which element should a change control form capture?
- Personal opinions of staff only
- Description of change, reason, risk assessment, impacted documents, approvals, and implementation plan
- Only cost estimates
- Only the date of request
Correct Answer: Description of change, reason, risk assessment, impacted documents, approvals, and implementation plan
Q15. What is ‘version control’ in change management?
- Controlling staff versions in payroll
- Maintaining unique identifiers and history for each document revision
- Managing customer versions of a product
- Inventory counting method
Correct Answer: Maintaining unique identifiers and history for each document revision
Q16. How are risk-based decisions used in change control?
- Risk is ignored to speed up changes
- Risk assessment determines level of testing, review, and approval required
- All changes require identical testing regardless of risk
- Risk is only considered after regulatory inspection
Correct Answer: Risk assessment determines level of testing, review, and approval required
Q17. Which metric helps monitor the effectiveness of a change control system?
- Number of cafeteria complaints
- Percent of changes closed on time, number of repeat changes, and post-implementation failures
- Total number of suppliers worldwide
- Volume of raw materials ordered
Correct Answer: Percent of changes closed on time, number of repeat changes, and post-implementation failures
Q18. What should be done if a change affects validated processes?
- No action required
- Evaluate validation impact and perform revalidation or partial validation as needed
- Only notify maintenance
- Wait until next product launch
Correct Answer: Evaluate validation impact and perform revalidation or partial validation as needed
Q19. How long should change control records typically be retained?
- Until the next day
- Per regulatory requirements, usually the retention period for GMP records (often several years beyond product shelf life or as per regulations)
- Only during staff employment
- Never retained
Correct Answer: Per regulatory requirements, usually the retention period for GMP records (often several years beyond product shelf life or as per regulations)
Q20. What is the difference between a deviation and a change control?
- Deviation is planned, change control is unplanned
- Deviation records an unplanned departure from procedure; change control manages planned modifications to systems or procedures
- They are identical terms
- Deviation applies only to marketing
Correct Answer: Deviation records an unplanned departure from procedure; change control manages planned modifications to systems or procedures
Q21. Which document should be updated when a controlled SOP is changed?
- Company press releases
- All impacted controlled documents, training records, and possibly batch records
- Payroll spreadsheets
- External social media posts
Correct Answer: All impacted controlled documents, training records, and possibly batch records
Q22. Who should receive training after an approved procedural change?
- Only external auditors
- All personnel affected by the change before implementation
- Only senior management
- Only the person who requested the change
Correct Answer: All personnel affected by the change before implementation
Q23. What role does the Quality Risk Management (QRM) play in change control?
- QRM is not related to change control
- QRM provides structured methods to assess and control risks associated with proposed changes
- QRM is only used for financial decisions
- QRM replaces all approvals
Correct Answer: QRM provides structured methods to assess and control risks associated with proposed changes
Q24. Which is a common reason for change control rejection?
- Excessive supporting data
- Insufficient justification, missing impact assessment, or inadequate risk mitigation
- Timely submission
- Too many approvers
Correct Answer: Insufficient justification, missing impact assessment, or inadequate risk mitigation
Q25. In electronic document management, what control is important for change control?
- Open editing without audit trail
- Audit trails, access controls, and electronic signatures to ensure integrity
- Public sharing of drafts
- Deleting previous versions permanently
Correct Answer: Audit trails, access controls, and electronic signatures to ensure integrity
Q26. When updating labeling, which aspect must be reviewed under change control?
- Only color preferences
- Regulatory compliance, content accuracy, artwork control, and printing validation
- Only the weight of the label
- Only the vendor’s logo
Correct Answer: Regulatory compliance, content accuracy, artwork control, and printing validation
Q27. What is a “controlled change log” used for?
- Tracking cafeteria menus
- Recording all approved and implemented changes, dates, approvers, and status for audit traceability
- Replacing batch records entirely
- Tracking office supplies
Correct Answer: Recording all approved and implemented changes, dates, approvers, and status for audit traceability
Q28. Which department should usually lead investigation when a change causes a negative quality impact?
- Marketing
- Quality Assurance in collaboration with affected technical departments
- IT support only
- Security
Correct Answer: Quality Assurance in collaboration with affected technical departments
Q29. How should change prioritization be determined?
- By random selection
- Based on risk, regulatory impact, patient safety, and business continuity considerations
- Only by chronological order received
- Only by cost
Correct Answer: Based on risk, regulatory impact, patient safety, and business continuity considerations
Q30. What must be verified before closing a change control?
- That the change was implemented, required testing completed, training done, documentation updated, and effectiveness confirmed
- That only the requester is satisfied
- That production quotas were increased
- That external consultants approved it informally
Correct Answer: That the change was implemented, required testing completed, training done, documentation updated, and effectiveness confirmed
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com