Introduction: Packaging and labeling system inspection MCQs With Answer is a focused study resource designed for M.Pharm students preparing for exams and industry roles in pharmaceutical quality assurance. This collection covers critical aspects of packaging and labeling inspections, including regulatory expectations, label control, line clearance, reconciliation, tamper-evidence, serialization, and documentation practices. Questions emphasize practical inspection scenarios, deviation investigation, and risk-based controls to deepen your understanding of how packaging integrity and accurate labeling protect patient safety and regulatory compliance. Use these MCQs to test knowledge, identify gaps, and reinforce best practices used during packaging and labeling audits and routine inspections.
Q1. What is the primary purpose of label reconciliation during a packaging run?
- To verify label artwork quality
- To ensure the number of printed labels matches the number applied to products
- To confirm label supplier billing accuracy
- To check the label stock storage conditions
Correct Answer: To ensure the number of printed labels matches the number applied to products
Q2. During a packaging line inspection, which control is most important to prevent mix-ups between similar products?
- Environmental monitoring of the packaging area
- Use of color-coding and physical segregation with documented line clearance
- Random sampling of finished goods for potency
- Verification of label adhesive properties
Correct Answer: Use of color-coding and physical segregation with documented line clearance
Q3. What is a critical element of a packaging line’s changeover procedure?
- Immediate start of production to reduce downtime
- Thorough cleaning, line clearance, and verification of correct labels and materials
- Reprinting labels on site
- Only visually inspecting the first 10 units
Correct Answer: Thorough cleaning, line clearance, and verification of correct labels and materials
Q4. Which document is essential to demonstrate that label artwork has been reviewed and authorized before use?
- Packaging equipment preventive maintenance log
- Label approval and specification (master label file or label change control record)
- Employee training matrix
- Shipping manifest
Correct Answer: Label approval and specification (master label file or label change control record)
Q5. What is the regulatory reason for including a batch number and expiry date on pharmaceutical labels?
- To improve marketing appeal
- To enable product traceability and support recalls
- To meet transportation labeling requirements
- To indicate supplier details
Correct Answer: To enable product traceability and support recalls
Q6. Which inspection activity helps detect label printing defects that could affect readability or dosage instructions?
- Verification of label adhesive strength
- Barcode verification and optical read tests of human-readable and machine-readable content
- Measurement of carton dimensions
- Checking pallet load stability
Correct Answer: Barcode verification and optical read tests of human-readable and machine-readable content
Q7. What is the purpose of tamper-evident features on packaging?
- To make packaging more expensive
- To provide visible evidence of unauthorized opening or alteration
- To enhance shelf appearance
- To increase production speed
Correct Answer: To provide visible evidence of unauthorized opening or alteration
Q8. Which practice is part of an effective labeling change control process?
- Allowing operators to edit label templates directly on the line
- Formal review, approval, and version control with impact assessment
- Discarding old label masters without record
- Outsourcing without supplier qualification
Correct Answer: Formal review, approval, and version control with impact assessment
Q9. During an inspection, what indicates inadequate control of printed label inventory?
- Accurate tracking of label stock receipts and usage
- Unaccounted-for label stock or missing reconciliation records
- Labels stored in climate-controlled conditions
- Periodic supplier audits
Correct Answer: Unaccounted-for label stock or missing reconciliation records
Q10. Which validation activity is specifically relevant for automated label applicators?
- Adult education on packaging regulations
- Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for applicator accuracy
- Inventory checks of carton blanks
- Verification of pallet wrapping tension
Correct Answer: Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for applicator accuracy
Q11. What is the inspector most likely to check to confirm label placement consistency?
- Label invoice from supplier
- Sampled measurement of label position and orientation on finished units against specification
- Storage location of empty cartons
- Training certificates of warehouse staff
Correct Answer: Sampled measurement of label position and orientation on finished units against specification
Q12. Why is a photostatic or electronic master label archive important?
- It reduces printing costs
- It preserves the authorized label version for traceability and audit purposes
- It shortens production time
- It allows operators to modify labels quickly
Correct Answer: It preserves the authorized label version for traceability and audit purposes
Q13. What is a critical inspection point for serialized products during packaging?
- Color of the product packaging ink
- Verification of serialization data capture, uniqueness, and linkage to batch records
- Weight of the pallet
- Supplier lead time for cartons
Correct Answer: Verification of serialization data capture, uniqueness, and linkage to batch records
Q14. Which action should be taken when a mislabeling event is discovered on a packaging line?
- Continue production and investigate later
- Stop the line, segregate affected product, conduct an investigation and perform corrective actions
- Reapply labels without documentation
- Discard the entire batch immediately without investigation
Correct Answer: Stop the line, segregate affected product, conduct an investigation and perform corrective actions
Q15. In label inspection sampling, what statistical approach improves detection of defects without checking every unit?
- 100% inspection only
- Risk-based sampling plans and acceptance quality limits (AQL)
- Visual inspection of pallets only
- Verifying invoices for label quantities
Correct Answer: Risk-based sampling plans and acceptance quality limits (AQL)
Q16. Which of the following is a key element of label template controls?
- Allowing multiple uncontrolled file copies across departments
- Maintaining a single controlled master template with locked fields and change history
- Using handwritten label adjustments on the line
- Frequent unapproved artwork edits for speed
Correct Answer: Maintaining a single controlled master template with locked fields and change history
Q17. What is the inspector verifying when checking child-resistant packaging features?
- That the artwork colors are vibrant
- That packaging mechanisms meet specified performance and regulatory child-resistance tests
- That the carton size is minimal
- That labels have a glossy finish
Correct Answer: That packaging mechanisms meet specified performance and regulatory child-resistance tests
Q18. How should expired or obsolete labels be controlled to prevent misuse?
- Keep them near the line for emergency use
- Segregate, clearly mark as obsolete, and destroy under documented procedures
- Allow them to be used if staff approve
- Store them without records for future review
Correct Answer: Segregate, clearly mark as obsolete, and destroy under documented procedures
Q19. Which inspection finding would indicate inadequate training related to labeling operations?
- Complete and up-to-date training records with assessments
- Frequent labeling errors attributed to operator unfamiliarity and missing competency records
- Periodic supervisory audits of labeling activities
- Well-documented SOPs available on the shop floor
Correct Answer: Frequent labeling errors attributed to operator unfamiliarity and missing competency records
Q20. For multinational labeling requirements, what must be verified during an inspection?
- That only one language is used on all labels globally
- That labels comply with country-specific regulatory text, language, and mandatory symbols as per local registrations
- That the label paper is sourced locally
- That packaging colors match competitor products
Correct Answer: That labels comply with country-specific regulatory text, language, and mandatory symbols as per local registrations
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