Change control procedures MCQs With Answer

Change control procedures MCQs With Answer is designed to help M.Pharm students master the critical concepts of formal change management in pharmaceutical quality systems. This blog features focused multiple-choice questions that probe regulatory expectations, risk-based assessments, documentation practices, validation impacts, and the role of cross-functional Change Control Boards. Questions cover real-world scenarios such as emergency changes, supplier modifications, computerized system updates, and regulatory submission pathways to build practical decision-making skills. Each MCQ includes clear options and correct answers to reinforce learning and prepare students for university exams and practical industry responsibilities in QC & QA functions. Use these questions for self-assessment and deeper topic revision.

Q1. What best describes a formal change control system in pharmaceutical manufacturing?

• A reactive process used only when deviations occur
• A formal documented system to propose, assess, approve, implement and review changes
• An informal communication between departments for small adjustments
• A procedure limited to updating batch documentation

Correct Answer: A formal documented system to propose, assess, approve, implement and review changes

Q2. What is the correct first step when initiating a change control?

• Implement the change immediately
• Raise a change request or change initiation form
• Perform full validation studies
• Notify regulatory authority

Correct Answer: Raise a change request or change initiation form

Q3. Which group is primarily responsible for reviewing and approving changes?

• Individual department head where change originates
• Change Control Board or cross-functional team including QA
• External consultant only
• Production operators implementing the change

Correct Answer: Change Control Board or cross-functional team including QA

Q4. Which risk assessment tool is commonly used to evaluate the impact of a proposed change?

• HACCP exclusively
• Failure Mode and Effects Analysis (FMEA)
• Random sampling without analysis
• Only historical trend review

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q5. Which type of change typically requires prior regulatory submission or approval?

• Administrative changes with no quality impact
• Minor editorial changes to label text
• Major changes that could affect product quality, safety, or efficacy
• Internal SOP format updates only

Correct Answer: Major changes that could affect product quality, safety, or efficacy

Q6. How should an emergency change that affects product quality be handled?

• Implemented immediately without documentation
• Implemented with immediate containment, documented, and followed by retrospective assessment and approval
• Ignored until the next scheduled Change Control Board meeting
• Only communicated verbally to production staff

Correct Answer: Implemented with immediate containment, documented, and followed by retrospective assessment and approval

Q7. What is the purpose of an effectiveness check after implementing a change?

• To close the change control without further review
• To verify the change achieved the intended result and did not introduce new risks
• To notify suppliers only
• To reduce documentation requirements

Correct Answer: To verify the change achieved the intended result and did not introduce new risks

Q8. Which document should detail the stepwise procedure for managing changes in a pharmaceutical site?

• Batch production record
• Change control standard operating procedure (SOP)
• Marketing brochure
• Individual operator notes

Correct Answer: Change control standard operating procedure (SOP)

Q9. On what basis are changes typically classified as minor or major?

• Based solely on cost impact
• Based on the color of labels affected
• Based on potential impact on product quality, safety, efficacy, and regulatory compliance
• Based only on the department proposing the change

Correct Answer: Based on potential impact on product quality, safety, efficacy, and regulatory compliance

Q10. When is revalidation or requalification usually required after a change?

• Only when the change is cosmetic
• When the change affects a previously validated process, equipment, or critical parameter
• Never required for supplier changes
• Only if the regulatory authority requests it

Correct Answer: When the change affects a previously validated process, equipment, or critical parameter

Q11. Who should perform the impact assessment for a proposed change?

• The initiating operator alone
• A cross-functional team including QA, QC, production, engineering and regulatory as required
• An external auditor only
• Sales department only

Correct Answer: A cross-functional team including QA, QC, production, engineering and regulatory as required

Q12. How are deviations, CAPA and change control related?

• They are unrelated quality systems
• Changes may be initiated as corrective actions from deviations or CAPA investigations
• CAPA replaces the need for change control
• Deviations always negate the need for change control

Correct Answer: Changes may be initiated as corrective actions from deviations or CAPA investigations

Q13. Which metric is useful to monitor the performance of a change control system?

• Number of printer cartridges used
• Average cycle time from change request to closure and percent of emergency changes
• Number of coffee breaks during meetings
• Only the number of changes raised without timing

Correct Answer: Average cycle time from change request to closure and percent of emergency changes

Q14. What special considerations apply when changing computerized systems used for GMP activities?

• No validation or documentation is needed for software
• Changes require computerized system validation and adherence to GAMP principles plus documented testing
• Only the IT department needs to be informed
• Backups alone are sufficient

Correct Answer: Changes require computerized system validation and adherence to GAMP principles plus documented testing

Q15. When a supplier changes a raw material specification or manufacturer, the appropriate action is to:

• Accept all deliveries without review
• Manage via change control with supplier assessment, potential requalification, and impact evaluation
• Only change the PO terms
• Ignore until a product failure occurs

Correct Answer: Manage via change control with supplier assessment, potential requalification, and impact evaluation

Q16. If a formulation component is modified, what must typically be performed?

• Immediate product launch without testing
• Stability studies, analytical method evaluation, and possible clinical/regulatory assessment depending on impact
• Only update the ingredient name on label
• Only notify marketing

Correct Answer: Stability studies, analytical method evaluation, and possible clinical/regulatory assessment depending on impact

Q17. The FDA CBE-30 (Changes Being Effected in 30 days) pathway allows what?

• Immediate permanent change without submission
• Implementation of certain changes 30 days after submission unless FDA notifies otherwise
• Automatic denial of any change
• Changes must wait one year for approval

Correct Answer: Implementation of certain changes 30 days after submission unless FDA notifies otherwise

Q18. Retrospective (post-implementation) change control approval is acceptable when:

• It is the routine approach for all changes
• Only used in justified emergency circumstances with full documentation, review and corrective actions
• No documentation is provided
• Regulators always prefer retrospective change control

Correct Answer: Only used in justified emergency circumstances with full documentation, review and corrective actions

Q19. A typical Change Control Board should include which members?

• Only the plant manager
• Representatives from QA, QC, Production, Engineering, Regulatory Affairs and R&D as applicable
• Only external vendors
• Only marketing and sales

Correct Answer: Representatives from QA, QC, Production, Engineering, Regulatory Affairs and R&D as applicable

Q20. Can a product batch be released to market based on processes changed but not yet approved by change control?

• Yes, if production staff approve it informally
• No, batches impacted by unapproved changes should not be released until change control approval and necessary validation are complete
• Yes, if the change is documented in a notebook
• Only if the change was verbal

Correct Answer: No, batches impacted by unapproved changes should not be released until change control approval and necessary validation are complete

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