Labeling and packing of drugs are essential components of pharmaceutical quality assurance that ensure safety, efficacy, and regulatory compliance. For B. Pharm students, mastering drug labeling elements—brand/generic name, strength, batch number, manufacturing and expiry dates, storage conditions, manufacturer details—and understanding packaging types (primary, secondary, tertiary), container-closure systems, tamper-evident and child-resistant features is vital. Topics include stability, shelf-life, serialization, barcodes, package inserts, GMP, WHO/ICH/FDA/CDSCO requirements, and prevention of medication errors. Clear labeling supports traceability, pharmacovigilance, and patient adherence. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which of the following is NOT typically required on a prescription drug label?
- Generic name
- Batch number
- Storage conditions
- Prescriber’s home address
Correct Answer: Prescriber’s home address
Q2. The primary purpose of tamper-evident packaging is to:
- Improve aesthetic appeal
- Indicate if package integrity has been compromised
- Extend shelf-life
- Reduce production costs
Correct Answer: Indicate if package integrity has been compromised
Q3. Which component defines the container-closure system?
- Tablet color and shape
- Material and design of primary container and its closure
- Manufacturer’s marketing strategy
- Prescription labeling font size
Correct Answer: Material and design of primary container and its closure
Q4. Batch number on a drug label primarily enables:
- Price comparison across brands
- Traceability and targeted recalls
- Determination of therapeutic class
- Patient identification
Correct Answer: Traceability and targeted recalls
Q5. According to good labeling practice, expiry date should be expressed as:
- Exact day, month, and year or month and year as per regulation
- Only the year of expiry
- Manufacturing year plus five years
- Week number and year
Correct Answer: Exact day, month, and year or month and year as per regulation
Q6. Which regulation body provides international guidance on pharmaceutical labeling and stability testing?
- WHO and ICH
- Local chamber of commerce
- ISO 9000 only
- World Bank
Correct Answer: WHO and ICH
Q7. Child-resistant packaging is most important for which product attribute?
- Low-cost over-the-counter analgesics
- High-risk or toxic medications
- Cosmetic creams
- Bandaging materials
Correct Answer: High-risk or toxic medications
Q8. Which of the following is a critical labeling element for controlled substances?
- Barcode only
- Controlled substance schedule and handling warnings
- Manufacturer’s stock photo
- Optional promotional claims
Correct Answer: Controlled substance schedule and handling warnings
Q9. Serialization in drug packaging primarily helps to:
- Reduce tablet disintegration time
- Prevent counterfeiting and enable track-and-trace
- Lower manufacturing energy consumption
- Enhance pill taste
Correct Answer: Prevent counterfeiting and enable track-and-trace
Q10. The package insert (patient information leaflet) should include:
- Dosage instructions, contraindications, side effects, and storage
- Only manufacturer contact details
- Detailed manufacturing equipment list
- Company financial reports
Correct Answer: Dosage instructions, contraindications, side effects, and storage
Q11. Which packaging level is designed for bulk transportation and palletizing?
- Primary packaging
- Secondary packaging
- Tertiary packaging
- Leaflet packaging
Correct Answer: Tertiary packaging
Q12. A stability indicating label should communicate:
- Storage conditions and shelf-life based on stability data
- Number of pills per bottle only
- Company marketing claims
- Sample manufacturing recipe
Correct Answer: Storage conditions and shelf-life based on stability data
Q13. Which symbol indicates that a drug must be stored between 2°C and 8°C?
- Open book symbol
- Snowflake with temperature range or explicit text
- Sun with 30°C
- Recycling triangle
Correct Answer: Snowflake with temperature range or explicit text
Q14. Misbranding of a drug refers to:
- Using non-pharmaceutical excipients
- False or misleading labeling or missing required information
- Packaging in glass instead of plastic
- Having a different color tablet
Correct Answer: False or misleading labeling or missing required information
Q15. Which labeling requirement aids adverse event reporting and pharmacovigilance?
- Barcode only
- Batch/lot number and manufacturer contact information
- Decorative logo
- Price tag
Correct Answer: Batch/lot number and manufacturer contact information
Q16. The term “container closure integrity” means:
- The package is attractive
- The container and closure prevent ingress/egress of contaminants and maintain sterility where required
- The closure matches brand colors
- The container is recyclable
Correct Answer: The container and closure prevent ingress/egress of contaminants and maintain sterility where required
Q17. A secondary label typically contains which of the following?
- Bulk shipment pallet ID only
- Marketing copy and decorative images only
- Detailed regulatory information, package contents, and handling instructions
- Internal manufacturing code only
Correct Answer: Detailed regulatory information, package contents, and handling instructions
Q18. Which is the most appropriate action if a mislabeled batch is detected before distribution?
- Distribute anyway to meet demand
- Quarantine the batch and investigate root cause
- Change label in the field by hand
- Return to supplier without documentation
Correct Answer: Quarantine the batch and investigate root cause
Q19. What does the term “beyond-use date (BUD)” apply to?
- Only to unopened factory-sealed products
- Prepared or repackaged sterile and non-sterile compounded preparations
- Marketing materials
- Manufacturing equipment maintenance
Correct Answer: Prepared or repackaged sterile and non-sterile compounded preparations
Q20. Which practice improves readability of critical label information?
- Using very small condensed fonts
- Clear typography, adequate font size, contrast, and use of pictograms
- Using only cursive script
- Printing information on the underside of packaging
Correct Answer: Clear typography, adequate font size, contrast, and use of pictograms
Q21. Which data element is essential for cold chain management labeling?
- Net weight only
- Minimum retail price
- Specific storage temperature range and handling instructions
- Manufacturer’s logo size
Correct Answer: Specific storage temperature range and handling instructions
Q22. Over-labeling is used primarily to:
- Conceal safety warnings
- Add new information without reprinting original packaging
- Reduce shelf-life
- Replace primary container material
Correct Answer: Add new information without reprinting original packaging
Q23. Which packaging material property is most important for moisture-sensitive drugs?
- High oxygen permeability
- Low moisture vapor transmission rate (MVTR)
- High transparency only
- Magnetic susceptibility
Correct Answer: Low moisture vapor transmission rate (MVTR)
Q24. Pharmacopoeial labeling requirements are generally intended to ensure:
- Consistency, safety, and correct information for medicines
- Maximum advertising space
- Minimal information disclosure
- Faster production times
Correct Answer: Consistency, safety, and correct information for medicines
Q25. What is the role of barcodes on drug packaging?
- Only aesthetic enhancement
- Enable electronic scanning for inventory, dispensing, and traceability
- Replace all textual labeling
- Reduce drug potency
Correct Answer: Enable electronic scanning for inventory, dispensing, and traceability
Q26. Which is a common requirement for prescription drug labeling to reduce medication errors?
- Include color-coded pills without text
- Clear statements of strength, route, frequency, and indication where applicable
- Omit batch number
- Use complex medical jargon only
Correct Answer: Clear statements of strength, route, frequency, and indication where applicable
Q27. Which test assesses the ability of packaging to protect from physical shocks during transport?
- Microbial limit test
- Drop and shock testing
- Assay by HPLC
- pH measurement
Correct Answer: Drop and shock testing
Q28. Which labeling practice supports multi-lingual markets?
- Provide critical information in required local languages and use standardized pictograms
- Include only English text everywhere
- Use different drug names per country without cross-reference
- Hide warnings in fine print
Correct Answer: Provide critical information in required local languages and use standardized pictograms
Q29. What is an important consideration when selecting inks and adhesives for pharmaceutical labels?
- They should migrate into the product to improve taste
- They must be compatible, non-reactive, and not affect product stability
- They should always be solvent-based regardless of product
- They must be magnetic
Correct Answer: They must be compatible, non-reactive, and not affect product stability
Q30. Which action is required if post-marketing surveillance shows a serious adverse reaction linked to labeled instructions?
- Ignore the findings
- Initiate label revision, risk communication, and regulatory reporting
- Change packaging color only
- Increase production without change
Correct Answer: Initiate label revision, risk communication, and regulatory reporting
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