Labeling & Printing Systems MCQs With Answer

Labeling & Printing Systems MCQs With Answer is a focused quiz collection designed for M.Pharm students studying MIP 203T – Pharmaceutical Production Technology. This set addresses practical and regulatory aspects of pharmaceutical label production — from printing technologies (thermal transfer, hot foil, inkjet, flexography) to substrates, adhesives, applicators, barcode symbologies, serialization, and in-line verification. Questions emphasize real-world production line integration, quality control metrics, validation requirements (IQ/OQ/PQ), and regulatory expectations (EU FMD, FDA). Each MCQ tests conceptual understanding and operational decision-making required to select and validate appropriate labeling and printing solutions in regulated pharmaceutical manufacturing environments.

Q1. What is the primary purpose of labeling and printing systems in pharmaceutical manufacturing?

• To decorate packaging for marketing appeal
• To provide accurate product identification and regulatory information
• To reduce product weight by adding labels
• To sterilize containers during labeling

Correct Answer: To provide accurate product identification and regulatory information

Q2. Which printing technology is most commonly used for high-resolution, variable alphanumeric text and barcode printing on pressure-sensitive labels in pharma lines?

• Gravure printing
• Flexographic printing
• Thermal transfer printing
• Offset lithography

Correct Answer: Thermal transfer printing

Q3. Which 2D matrix code is the standard most widely adopted for unit-level serialization in the pharmaceutical industry?

• QR Code
• PDF417
• DataMatrix
• Aztec Code

Correct Answer: DataMatrix

Q4. In barcode printing and verification, what does the term “quiet zone” refer to?

• The printed area of the barcode
• A blank margin around the barcode required for accurate scanning
• The color contrast between bars and background
• The resolution of the barcode image

Correct Answer: A blank margin around the barcode required for accurate scanning

Q5. Which parameter quantifies the print resolution of a thermal or inkjet printing system?

• PSI (pounds per square inch)
• DPI (dots per inch)
• RPM (revolutions per minute)
• LPI (lines per inch)

Correct Answer: DPI (dots per inch)

Q6. Which label applicator type is best suited when non-contact application is needed to avoid damaging delicate or curved surfaces?

• Wipe-on applicator
• Tamp applicator with contact
• Blow-on (air) applicator
• Roll-on applicator

Correct Answer: Blow-on (air) applicator

Q7. For a label that must be removable by the end user without leaving adhesive residue, which adhesive type should be specified?

• Permanent acrylic adhesive
• Rubber-based permanent adhesive
• High-tack aggressive adhesive
• Removable adhesive

Correct Answer: Removable adhesive

Q8. During equipment qualification for a new labeling line, what is the primary objective of Operational Qualification (OQ)?

• To demonstrate that the installed equipment is physically present
• To verify that the equipment operates within specified limits under simulated conditions
• To perform routine production runs without formal testing
• To assess long-term process capability in commercial production

Correct Answer: To verify that the equipment operates within specified limits under simulated conditions

Q9. Which inline device is specifically used to check barcode readability and grade the code immediately after label application?

• Web cleaner
• Barcode verifier / ISO verifier
• Die-cutter
• Thermal transfer ribbon sensor

Correct Answer: Barcode verifier / ISO verifier

Q10. Which printing method transfers metallic or pigmented foil onto a substrate using heat and pressure, often used for decorative or security elements?

• Digital inkjet printing
• Hot foil stamping
• Flexographic printing
• Gravure printing

Correct Answer: Hot foil stamping

Q11. Which printing process uses flexible relief plates and is widely used for high-speed continuous-roll label production?

• Screen printing
• Flexographic printing
• Offset lithography
• Thermal transfer printing

Correct Answer: Flexographic printing

Q12. Why is humidity control important in label printing and application on pharmaceutical production lines?

• Humidity increases ink color vibrancy
• Moisture can cause web distortion, adhesive activation changes, and poor print quality
• High humidity completely prevents static build-up
• Humidity only affects metal components and is irrelevant to labels

Correct Answer: Moisture can cause web distortion, adhesive activation changes, and poor print quality

Q13. What does serialization mean in the context of pharmaceutical labeling?

• Printing the same barcode on all units
• Assigning and printing a unique identifier to each saleable unit
• Grouping products by batch number only
• Using color coding to show expiry

Correct Answer: Assigning and printing a unique identifier to each saleable unit

Q14. Which linear barcode symbology is commonly used for representing GTIN on retail pharmaceutical packaging (EAN/UPC family)?

• Code 39
• Code 128
• EAN-13 / UPC-A
• Interleaved 2 of 5

Correct Answer: EAN-13 / UPC-A

Q15. Which thermal printing mode requires a consumable ribbon between the printhead and label stock?

• Direct thermal printing
• Thermal transfer printing
• Inkjet thermal printing
• Laser thermal printing

Correct Answer: Thermal transfer printing

Q16. Under the EU Falsified Medicines Directive, what two safety features are required on the outer packaging of prescription medicines?

• Colorful branding and tamper-proof tapes
• Unique identifier (e.g., DataMatrix) and an anti-tampering device
• RFID tag and holographic label only
• Batch number and generic name only

Correct Answer: Unique identifier (e.g., DataMatrix) and an anti-tampering device

Q17. Which substrate property is most critical when selecting labels for products undergoing heat-based form-fill-seal or blister thermoforming?

• Optical brightness
• Heat resistance and dimensional stability
• Cost per square meter
• Surface gloss for decoration

Correct Answer: Heat resistance and dimensional stability

Q18. In production, what does “overprinting” typically refer to on pre-printed labels or cartons?

• Printing graphics that cover the entire label surface
• Printing variable data such as batch number, expiry, or serial code onto pre-printed stock
• Applying a second adhesive layer over the first
• Printing labels twice to increase contrast

Correct Answer: Printing variable data such as batch number, expiry, or serial code onto pre-printed stock

Q19. In label printing quality control, what does the statistical metric Cpk indicate?

• The frequency of printer head cleaning cycles
• The process capability — how well a process can produce within specification limits
• The speed of the labeling line in units per minute
• The optical density of printed black ink

Correct Answer: The process capability — how well a process can produce within specification limits

Q20. What is a key advantage of RFID tagging compared to barcodes in pharmaceutical inventory management?

• RFID requires direct line-of-sight scanning similar to barcodes
• RFID tags are always cheaper than printed barcodes
• RFID enables non-line-of-sight, bulk reading and faster inventory counts
• RFID eliminates the need for any regulatory information on packaging

Correct Answer: RFID enables non-line-of-sight, bulk reading and faster inventory counts

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