Packaging operations under GMP MCQs With Answer

Packaging operations under GMP MCQs With Answer

This quiz set is designed for M. Pharm students to reinforce understanding of packaging operations under Good Manufacturing Practices (GMP). It covers facility design, equipment validation, line clearance, labeling controls, serialization, packaging material testing, environmental monitoring, contamination control, documentation, and regulatory expectations. Questions emphasize practical decision-making, critical controls, and QA responsibilities encountered in industrial packaging lines for pharmaceuticals. The MCQs are structured to deepen comprehension of risk mitigation, process validation (IQ/OQ/PQ), operator training and gowning, and quality checks necessary to ensure product integrity, patient safety, and compliance with global regulatory requirements.

Q1. Which of the following is the most important reason for implementing line clearance procedures before starting a packaging run?

• To ensure the packaging machine is lubricated
• To verify that no previous product, labels, tools, or materials remain that could cause mix-ups or cross-contamination
• To start environmental monitoring
• To calibrate the weight-checking scales

Correct Answer: To verify that no previous product, labels, tools, or materials remain that could cause mix-ups or cross-contamination

Q2. In packaging areas handling non-sterile solid oral dosage forms, the primary purpose of controlled humidity is to:

• Reduce static electricity in the building
• Prevent label ink from drying too quickly
• Preserve tablet/capsule physical integrity (e.g., prevent sticking, capping, or moisture uptake)
• Improve operator comfort

Correct Answer: Preserve tablet/capsule physical integrity (e.g., prevent sticking, capping, or moisture uptake)

Q3. During packaging validation, PQ (performance qualification) primarily demonstrates:

• That the vendor supplied the correct material
• That the packaging line performs consistently under simulated normal production conditions and meets predetermined acceptance criteria
• That installation was completed correctly
• That software documentation is adequate

Correct Answer: That the packaging line performs consistently under simulated normal production conditions and meets predetermined acceptance criteria

Q4. Which documentation is essential to reconcile label usage during and after a packaging run?

• Batch manufacturing record including label reconciliation records
• Only the invoice from the label supplier
• Maintenance log for the packaging machine
• Employee training records

Correct Answer: Batch manufacturing record including label reconciliation records

Q5. What is the key GMP requirement when printing batch numbers and expiry dates on primary packaging?

• Using the fastest available printer
• Ensuring legibility, traceability, and that coding equipment is validated and controlled to prevent misprints
• Printing solely in black ink
• Only printing dates at the secondary packaging stage

Correct Answer: Ensuring legibility, traceability, and that coding equipment is validated and controlled to prevent misprints

Q6. Which practice reduces risk of particulate contamination during powder filling on a packaging line?

• Using an open bench directly under the filling hopper
• Implementing local exhaust ventilation, enclosed filling systems, and regular cleaning of dust traps
• Keeping doors open to increase airflow
• Allowing operators to adjust hoppers during runs without PPE

Correct Answer: Implementing local exhaust ventilation, enclosed filling systems, and regular cleaning of dust traps

Q7. A primary purpose of sampling and inspection during packaging is to:

• Increase line throughput by reducing checks
• Detect defects or deviations early so corrective actions can prevent distribution of non-conforming product
• Reduce the need for batch release testing
• Replace environmental monitoring

Correct Answer: Detect defects or deviations early so corrective actions can prevent distribution of non-conforming product

Q8. For sterile product final packaging, which environmental classification is typically required for the immediate filling/stoppering area?

• ISO 9
• ISO 8
• ISO 5 (or Grade A/B depending on operation)
• Unclassified production area

Correct Answer: ISO 5 (or Grade A/B depending on operation)

Q9. Which of the following is a critical element of tamper-evident packaging design for oral solids?

• Heavy cardboard only
• Inclusion of seals, shrink bands, or sealed blisters that provide visible evidence of opening or tampering
• Use of plain adhesive tape
• Multiple labels overlapping a seam

Correct Answer: Inclusion of seals, shrink bands, or sealed blisters that provide visible evidence of opening or tampering

Q10. When changing over a packaging line from one product to another, which control is most important to prevent mix-ups?

• Rapidly increasing line speed
• Performing a documented changeover including cleaning, line clearance, label checks, and a hold point for QA approval
• Asking operators to visually inspect only
• Only changing the product hopper without changing labels

Correct Answer: Performing a documented changeover including cleaning, line clearance, label checks, and a hold point for QA approval

Q11. Which test is commonly used to verify integrity of sealed blister packs?

• pH testing of the tablet
• Dye ingress or vacuum decay/leak detection to confirm seal integrity
• Visual weight check only
• Friability testing

Correct Answer: Dye ingress or vacuum decay/leak detection to confirm seal integrity

Q12. What is the primary QA responsibility related to packaging materials received from suppliers?

• Only storing them in the warehouse
• Performing incoming inspection, identity, quality testing or certificate review, and releasing materials per supplier qualification
• Using them immediately to save time
• Assuming quality based on supplier reputation alone

Correct Answer: Performing incoming inspection, identity, quality testing or certificate review, and releasing materials per supplier qualification

Q13. Serialization on packaging lines is mainly used to:

• Improve aesthetics of cartons
• Enable product traceability, prevent counterfeiting, and support track-and-trace regulatory requirements
• Increase packing speed
• Reduce packaging material cost

Correct Answer: Enable product traceability, prevent counterfeiting, and support track-and-trace regulatory requirements

Q14. Which risk is most directly controlled by using child-resistant closures and appropriate labeling?

• Product potency loss
• Accidental ingestion by children and associated poisoning risk
• Environmental contamination
• Counterfeiting

Correct Answer: Accidental ingestion by children and associated poisoning risk

Q15. For packaging lines handling potent compounds, a primary engineering control is:

• Open conveyor belts without covers
• Containment enclosures, negative pressure isolators, and dedicated exhaust systems to protect operators and prevent cross-contamination
• Using only manual packaging to observe each dose
• Removing all PPE to improve dexterity

Correct Answer: Containment enclosures, negative pressure isolators, and dedicated exhaust systems to protect operators and prevent cross-contamination

Q16. What is the main objective of packaging process validation requalification (periodic revalidation)?

• To change equipment dramatically
• To demonstrate ongoing control and that the process remains capable and compliant over time after initial qualification
• To document employee vacations
• To increase production batches without testing

Correct Answer: To demonstrate ongoing control and that the process remains capable and compliant over time after initial qualification

Q17. Which action is part of an effective recall preparedness related to packaging operations?

• Not maintaining batch traceability
• Establishing clear procedures for product identification, quarantine, retrieval, communication, and documentation of recalled product including packaging codes
• Only informing marketing team after distribution
• Discarding all retained samples routinely

Correct Answer: Establishing clear procedures for product identification, quarantine, retrieval, communication, and documentation of recalled product including packaging codes

Q18. In automated packaging lines, what is a common in-process control to ensure correct fill weight?

• Random visual checks of bottle caps
• In-line checkweighers with reject mechanisms and periodic calibration checks
• Measuring room temperature only
• Counting labels weekly

Correct Answer: In-line checkweighers with reject mechanisms and periodic calibration checks

Q19. Why is retention sampling of packaged batches important under GMP?

• It reduces the need for any stability testing
• It provides representative samples for future identity, stability, and investigation testing in case of complaint or regulatory query
• It allows sales teams to use samples for promotion
• It is only required for sterile products

Correct Answer: It provides representative samples for future identity, stability, and investigation testing in case of complaint or regulatory query

Q20. Which element is essential in SOPs for packaging operations to ensure regulatory compliance?

• Vague language to allow flexibility
• Clear stepwise instructions, acceptance criteria, responsibilities, lines for record entries, and change control references
• Only diagrams without text
• Only references to external websites

Correct Answer: Clear stepwise instructions, acceptance criteria, responsibilities, lines for record entries, and change control references

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