Barcode-based medicine identification MCQs With Answer

Introduction

Barcode-based medicine identification is a critical topic for B. Pharm students, covering barcode symbologies (1D and 2D), GS1 standards, serialization, and verification methods used in pharmaceutical packaging and supply chains. Understanding GTIN, NDC mapping, Application Identifiers, expiry and batch encoding, and barcode scanning technologies helps ensure drug authentication, patient safety, inventory control, and regulatory compliance (FMD, DSCSA). Practical knowledge of barcode printing quality, quiet zones, check digits, DataMatrix and QR codes, and differences between barcodes and RFID prepares students for roles in quality assurance, hospital pharmacy, and production. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of applying barcodes to medicine packaging?

• Decorative labeling
• Automated identification and traceability
• Reducing manufacturing cost
• Replacing expiration dates

Correct Answer: Automated identification and traceability

Q2. Which barcode symbology is a two-dimensional matrix commonly used for medicine serialization?

• Code 128
• EAN-13
• DataMatrix
• UPC-A

Correct Answer: DataMatrix

Q3. In GS1 system, which identifier uniquely represents a trade item such as a specific pharmaceutical product?

• Batch number
• GTIN (Global Trade Item Number)
• SSCC
• Serial shipping container code

Correct Answer: GTIN (Global Trade Item Number)

Q4. What does serialization in pharmaceutical barcoding primarily prevent?

• Packaging waste
• Counterfeiting and diversion
• Color fading of labels
• Barcode scanning speed

Correct Answer: Counterfeiting and diversion

Q5. Which regulatory framework in the EU mandates unique identifiers and tamper-evidence on prescription medicines?

• HIPAA
• Falsified Medicines Directive (FMD)
• DSCSA
• ICH Guidelines

Correct Answer: Falsified Medicines Directive (FMD)

Q6. What is an Application Identifier (AI) in GS1 barcodes used for?

• Specifying print color
• Encoding specific data element semantics like expiry date or batch
• Measuring barcode height
• Determining scanner brand

Correct Answer: Encoding specific data element semantics like expiry date or batch

Q7. Which of the following is a linear (1D) barcode often used for human-readable product codes?

• QR Code
• DataMatrix
• Code 128
• PDF417

Correct Answer: Code 128

Q8. In pharmaceutical barcoding, what is the function of a check digit?

• Increase printing speed
• Detect common data entry or scanning errors
• Encrypt the barcode data
• Extend barcode physical size

Correct Answer: Detect common data entry or scanning errors

Q9. Which barcode property describes the required clear space around the symbol to ensure proper scanning?

• Quiet zone
• Check border
• Padding margin
• Frame gap

Correct Answer: Quiet zone

Q10. For hospital dispensing, scanning a medicine barcode primarily confirms which of the following?

• Therapeutic class
• Correct product, dose and patient match (when linked with patient ID)
• Manufacturer profitability
• Storage location

Correct Answer: Correct product, dose and patient match (when linked with patient ID)

Q11. Which GS1 data carrier is most space-efficient for encoding long strings like GTIN, batch, expiry and serial number?

• UPC-A
• Code 39
• DataMatrix
• Interleaved 2 of 5

Correct Answer: DataMatrix

Q12. The FDA’s U.S. Drug Supply Chain Security Act (DSCSA) focuses on which barcode-related requirement?

• Color printing requirements
• Serialization and interoperable tracing of prescription drugs
• Barcode symbology for OTC products only
• Mandatory QR codes for all drugs

Correct Answer: Serialization and interoperable tracing of prescription drugs

Q13. Which factor does NOT directly affect barcode print quality?

• Printer resolution (dpi)
• Ink contrast vs substrate
• Ambient room temperature during scanning
• Barcode size and module width

Correct Answer: Ambient room temperature during scanning

Q14. How does a 2D DataMatrix differ from a 1D barcode in error handling?

• 2D has no error correction
• 2D supports error correction (e.g., Reed-Solomon) allowing partial damage recovery
• 1D always encodes more data than 2D
• 1D uses Reed-Solomon and 2D does not

Correct Answer: 2D supports error correction (e.g., Reed-Solomon) allowing partial damage recovery

Q15. Which data element is typically encoded when applying GS1 AI (17)?

• Batch or lot number
• Serial shipping container code
• Expiration date
• Global location number

Correct Answer: Expiration date

Q16. What is the recommended action if a barcode verification grade is below specification?

• Ignore and ship product
• Reprint or adjust printing parameters and re-verify before release
• Reduce barcode size and retry
• Switch to a different symbology without root cause analysis

Correct Answer: Reprint or adjust printing parameters and re-verify before release

Q17. Which identifier is commonly used in the US to identify a specific formulation and packaging configuration of a drug?

• NDC (National Drug Code)
• ISBN
• GTIN-8 only
• SSCC

Correct Answer: NDC (National Drug Code)

Q18. What does barcode “scan density” refer to?

• The ink drying time
• The number of modules or pixels per unit length, affecting how much data can be encoded
• The barcode’s printed color
• The number of scans required to verify

Correct Answer: The number of modules or pixels per unit length, affecting how much data can be encoded

Q19. Which practice improves barcode readability on curved or small vials?

• Use a very high density linear barcode
• Use a suitable 2D symbology like DataMatrix and orient for scanner line-of-sight
• Print barcode on inner label only
• Reduce quiet zone to save space

Correct Answer: Use a suitable 2D symbology like DataMatrix and orient for scanner line-of-sight

Q20. What is the main advantage of GS1 Application Identifier (AI) concatenation?

• It reduces barcode height
• It allows multiple structured data elements (GTIN, lot, expiry, serial) to be encoded in one symbol
• It encrypts data against tampering
• It removes need for quiet zone

Correct Answer: It allows multiple structured data elements (GTIN, lot, expiry, serial) to be encoded in one symbol

Q21. Which scanner technology is most tolerant of damaged or poorly printed barcodes?

• Laser linear scanner
• CCD linear scanner
• 2D area imager
• Manual magnifier

Correct Answer: 2D area imager

Q22. When encoding expiry date with GS1 AI (17), what format is used?

• YYYY-MM-DD
• YYMMDD
• MMDDYY
• DDMMYYYY

Correct Answer: YYMMDD

Q23. Which of the following best describes aggregation in pharmaceutical serialization?

• Combining multiple serial numbers into a parent-child relationship for cartons and pallets
• Reducing barcode size across packages
• Generating check digits for GTIN
• Printing human-readable data only

Correct Answer: Combining multiple serial numbers into a parent-child relationship for cartons and pallets

Q24. What is the role of barcode verification equipment in production QA?

• To print barcodes faster
• To objectively grade barcode quality against ISO/GS1 standards
• To convert linear barcodes to 2D
• To remove the need for Application Identifiers

Correct Answer: To objectively grade barcode quality against ISO/GS1 standards

Q25. Which error would a Modulo 10 checksum most likely detect?

• Printer head failure
• A single digit transcription error and many adjacent digit transpositions
• Complete smudge of barcode
• Incorrect quiet zone

Correct Answer: A single digit transcription error and many adjacent digit transpositions

Q26. How does serialization support pharmacovigilance and recalls?

• By reducing batch sizes only
• By enabling precise identification of affected individual packs through unique serial numbers
• By removing expiry dates
• By anonymizing supply chain data

Correct Answer: By enabling precise identification of affected individual packs through unique serial numbers

Q27. Which is a key difference between barcode and RFID for medicines?

• Barcode allows remote reading without line-of-sight
• RFID typically enables non-line-of-sight bulk reading, while barcodes require line-of-sight
• RFID is always cheaper than barcodes
• Barcodes store more data than RFID tags

Correct Answer: RFID typically enables non-line-of-sight bulk reading, while barcodes require line-of-sight

Q28. What is the significance of human-readable text beneath barcodes on medicine packs?

• It is legally unnecessary
• It provides immediate human verification and fallback if scanners fail
• It increases barcode density
• It encodes encrypted data

Correct Answer: It provides immediate human verification and fallback if scanners fail

Q29. Which ISO/IEC standard family relates to barcode symbol print quality and grading?

• ISO 9001
• ISO/IEC 15415 and ISO/IEC 15416
• ISO 13485
• IEC 60601

Correct Answer: ISO/IEC 15415 and ISO/IEC 15416

Q30. For a GS1 DataMatrix encoding GTIN (01), batch (10) and expiry (17), what is essential to ensure correct interpretation by downstream systems?

• Omitting Application Identifiers
• Using correct AI prefixes and order or including separators for variable-length AIs
• Printing in color
• Using a proprietary symbology instead of GS1

Correct Answer: Using correct AI prefixes and order or including separators for variable-length AIs

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