Handling of complaints and evaluation process MCQs With Answer

Handling of complaints and evaluation process MCQs With Answer is a focused review for B.Pharm students covering systematic complaint handling, evaluation process steps, and quality assurance principles. This introduction highlights key topics: complaint logging, root cause analysis, CAPA (corrective and preventive actions), documentation, sample retention, pharmacovigilance, GMP compliance, trend analysis, and recall decision-making. Emphasis is placed on investigation workflows, interdepartmental responsibilities (QA, production, regulatory), and evidence-based evaluation to protect patient safety and ensure regulatory compliance. These MCQs aim to deepen technical understanding and practical skills needed for effective complaint management in pharmaceutical practice. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the first formal action when a customer complaint about a marketed drug product is received?

• Log the complaint in the complaint register
• Immediately discard the returned sample
• Send the complaint to sales for response
• Initiate a product recall without investigation

Correct Answer: Log the complaint in the complaint register

Q2. What is the primary objective of the complaint evaluation process?

• Determine the root cause and product impact
• Assign blame to manufacturing staff
• Increase product marketing
• Create more paperwork

Correct Answer: Determine the root cause and product impact

Q3. Within what timeframe should the customer typically be acknowledged after submitting a complaint?

• Acknowledge within 48 hours
• Acknowledge within 14 days
• No acknowledgement required
• Acknowledge after investigation completes

Correct Answer: Acknowledge within 48 hours

Q4. Which document defines the standardized steps for complaint handling in a pharmaceutical facility?

• Complaint Handling SOP
• Batch Manufacturing Record
• Stability Protocol
• Sales Promotion Manual

Correct Answer: Complaint Handling SOP

Q5. Which department is principally responsible for coordinating and approving a complaint investigation?

• Quality Assurance (QA)
• Production only
• Sales and Marketing
• External Audit Team

Correct Answer: Quality Assurance (QA)

Q6. What does CAPA stand for in the context of complaint management?

• Corrective and Preventive Actions
• Compliance and Production Audit
• Customer Appeal and Product Assessment
• Control and Processing Analysis

Correct Answer: Corrective and Preventive Actions

Q7. Which root cause analysis tool is commonly used during complaint investigations?

• 5 Whys analysis
• Stability testing
• Colorimetry
• Market share analysis

Correct Answer: 5 Whys analysis

Q8. What should be done with a returned product sample pending investigation?

• Retain the sample until investigation is complete and disposition decided
• Discard the sample immediately
• Send the sample to marketing
• Store the sample with scrap material

Correct Answer: Retain the sample until investigation is complete and disposition decided

Q9. Which complaint category indicates a potential risk to patient health and usually triggers urgent action?

• Critical (safety-related)
• Minor (cosmetic)
• Administrative
• Non-product related

Correct Answer: Critical (safety-related)

Q10. Which regulatory reference specifically includes requirements for handling complaints about finished pharmaceutical products?

• 21 CFR 211 (GMP for finished pharmaceuticals)
• ICH Q3B
• USP General Notices only
• EPA pesticide regulations

Correct Answer: 21 CFR 211 (GMP for finished pharmaceuticals)

Q11. Pharmacovigilance reporting in complaint handling primarily covers which type of event?

• Adverse drug reactions reported by patients or healthcare professionals
• Minor packaging scratches
• Delayed delivery notifications
• Staff absenteeism

Correct Answer: Adverse drug reactions reported by patients or healthcare professionals

Q12. Should batch manufacturing records be reviewed during a product complaint investigation?

• Yes, batch records must be reviewed to identify deviations
• No, batch records are irrelevant to complaints
• Only review if the complaint is about labeling
• Review only if requested by sales

Correct Answer: Yes, batch records must be reviewed to identify deviations

Q13. How does trend analysis of complaint data benefit quality management?

• Identifies recurring defects and systemic issues
• Increases product pricing
• Replaces the need for investigations
• Eliminates customer feedback

Correct Answer: Identifies recurring defects and systemic issues

Q14. Which of the following is an example of a preventive action following complaint evaluation?

• Revise SOPs and retrain staff to prevent recurrence
• Destroy returned samples immediately
• Transfer responsibility to sales
• Ignore non-critical complaints

Correct Answer: Revise SOPs and retrain staff to prevent recurrence

Q15. Who typically has authority to approve formal closure of a complaint investigation?

• Authorized person from Quality Assurance (QA)
• Line production supervisor
• Regional sales representative
• External consultant

Correct Answer: Authorized person from Quality Assurance (QA)

Q16. What is the usual retention period for complaint records according to GMP principles?

• For a period equal to the product shelf life plus one year
• Retention is not required
• One month after complaint closure
• Retain until next audit only

Correct Answer: For a period equal to the product shelf life plus one year

Q17. Which condition generally necessitates initiating a product recall?

• Confirmed risk to public health or serious quality defect
• Minor label formatting error that does not affect use
• Customer preference for a different flavor
• Small quantity packaging scratch

Correct Answer: Confirmed risk to public health or serious quality defect

Q18. For complaints suggesting contamination, which additional investigation step is most appropriate?

• Perform relevant microbiological testing
• Increase advertising
• Ignore if product passed release tests
• Return product to stock

Correct Answer: Perform relevant microbiological testing

Q19. Which function usually notifies regulators about a recall or safety issue in coordination with QA?

• Regulatory Affairs in coordination with QA
• Only the warehouse manager
• Customer service alone
• Human resources

Correct Answer: Regulatory Affairs in coordination with QA

Q20. Which tool is commonly used to record basic details of each complaint?

• Complaint register or log
• Employee payroll register
• Raw material purchase order
• Marketing database

Correct Answer: Complaint register or log

Q21. How should returned complaint samples be stored prior to analysis?

• Labelled and stored under defined product storage conditions
• Stored at room temperature without labeling
• Kept in the cafeteria
• Mixed with other waste

Correct Answer: Labelled and stored under defined product storage conditions

Q22. When evaluating a complaint, how should customer-supplied sample claims be treated?

• Consider the claims but verify by independent laboratory testing
• Accept customer claims as final without testing
• Reject customer samples immediately
• Send samples to sales for confirmation

Correct Answer: Consider the claims but verify by independent laboratory testing

Q23. Which activity is NOT typically part of the complaint evaluation process?

• Employee performance appraisal
• Root cause analysis
• Documentation of findings
• Implementation of CAPA

Correct Answer: Employee performance appraisal

Q24. What is the term for confirming that corrective actions have solved the root cause after implementation?

• Effectiveness check (verification/monitoring)
• Immediate recall
• Sales follow-up
• Document shredding

Correct Answer: Effectiveness check (verification/monitoring)

Q25. Which areas are assessed during impact assessment of a complaint?

• Patient safety, regulatory obligations, and commercial impact
• Only the product label color
• Only employee salaries
• Only shipping costs

Correct Answer: Patient safety, regulatory obligations, and commercial impact

Q26. How does Quality Risk Management (QRM) support complaint handling?

• Prioritizes investigations based on risk to patient safety and product quality
• Creates marketing strategies
• Limits investigations to high-value customers only
• Eliminates need for documentation

Correct Answer: Prioritizes investigations based on risk to patient safety and product quality

Q27. What is the appropriate approach to sample size for laboratory testing of a returned complaint?

• Use a representative sample from the returned batch for analysis
• Always test only one tablet regardless of batch size
• Test unrelated products instead
• Do not perform any testing

Correct Answer: Use a representative sample from the returned batch for analysis

Q28. What is a reasonable timeline guideline to complete an internal complaint investigation?

• Complete within SOP-defined timeline (typically within 30 days)
• Complete only after one year
• There is no need to set a timeline
• Complete within 1 hour regardless of complexity

Correct Answer: Complete within SOP-defined timeline (typically within 30 days)

Q29. What is the role of photographic evidence in complaint investigations?

• Supports investigation findings but should not be the sole basis for conclusions
• Is always sufficient alone to close investigations
• Is not allowed in regulated documentation
• Replaces laboratory testing

Correct Answer: Supports investigation findings but should not be the sole basis for conclusions

Q30. Which ethical consideration is essential when handling complaints involving patient information?

• Protect patient confidentiality and handle data per privacy requirements
• Share patient details freely for faster resolution
• Post customer complaints on social media
• Disclose patient identity to all departments

Correct Answer: Protect patient confidentiality and handle data per privacy requirements

G S Sachin

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