Official requirements for pharmaceutical containers MCQs With Answer offers B.Pharm students a concise, practical guide to regulatory and quality expectations for drug packaging. This introduction covers container closure integrity, material compatibility (glass Type I/II/III, HDPE, PET, PP), leachables and extractables, sterility and stability requirements, tamper-evident and child-resistant features, labeling and storage conditions, and relevant standards such as USP, ISO and EMA guidelines. Emphasis is on testing methods (dye ingress, helium leak, microbial challenge), documentation, and risk-based selection of containers to ensure safety, efficacy and compliance. The questions that follow reinforce critical concepts and prepare students for exams and industry roles. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What does “container closure integrity” primarily ensure for sterile parenteral products?
- Protection against light degradation
- Maintenance of a sterile barrier preventing microbial ingress
- Correct dosing information on the label
- Resistance to crushing during transport
Correct Answer: Maintenance of a sterile barrier preventing microbial ingress
Q2. Which glass type is preferred for injectable formulations due to highest chemical durability?
- Type III glass
- Type II glass
- Type I borosilicate glass
- Neutral glass
Correct Answer: Type I borosilicate glass
Q3. Which regulatory reference is commonly cited for plastics and leachables testing in pharmaceuticals?
- ICH Q1A only
- USP chapters and ICH Q3A/Q3B guidance
- ISO 9001 only
- FDA Food Code
Correct Answer: USP chapters and ICH Q3A/Q3B guidance
Q4. “Extractables” are best described as:
- Compounds formed only under normal storage
- Volatile gases released during sterilization
- Chemical species that can be removed from a packaging material under aggressive conditions
- Residual solvents intentionally added
Correct Answer: Chemical species that can be removed from a packaging material under aggressive conditions
Q5. A tamper-evident feature on a pharmaceutical package primarily provides:
- Child resistance
- Evidence of unauthorized access or opening
- UV protection for light-sensitive drugs
- Enhanced cushioning during shipping
Correct Answer: Evidence of unauthorized access or opening
Q6. Which test method is commonly used to assess container closure integrity non-destructively?
- Dye ingress destructive immersion
- Helium leak testing (vacuum decay or tracer gas)
- Visual inspection only
- pH measurement of the product
Correct Answer: Helium leak testing (vacuum decay or tracer gas)
Q7. Child-resistant packaging requirements are intended to reduce:
- Manufacturing costs
- Child access to hazardous medicines
- Shelf-life variability
- Packaging weight
Correct Answer: Child access to hazardous medicines
Q8. Which plastic is frequently used for bottles and offers good moisture barrier for solids?
- Polyethylene terephthalate (PET)
- Polystyrene (PS)
- Polyvinyl chloride (PVC)
- Polypropylene (PP)
Correct Answer: Polyethylene terephthalate (PET)
Q9. Leachables differ from extractables in that leachables are:
- Found only in packaging inks
- Observed in the drug product under normal storage conditions
- Only volatile contaminants
- Always intentionally added stabilizers
Correct Answer: Observed in the drug product under normal storage conditions
Q10. For sterile injectable vials, which closure attribute is critical to maintain during autoclave sterilization?
- Label adhesion only
- Closure elasticity and seal integrity
- Color of the septum
- Tamper-evident band flexibility
Correct Answer: Closure elasticity and seal integrity
Q11. Which standard addresses pharmaceutical container-closure system performance testing?
- ISO 9000
- USP container-closure related chapters (e.g., container-closure integrity)
- ASTM D412 only
- IEC electrical safety standards
Correct Answer: USP container-closure related chapters (e.g., container-closure integrity)
Q12. Which material property is most relevant when selecting packaging for photosensitive drugs?
- Thermal conductivity
- Light transmission / opacity
- Electrical resistance
- Magnetic susceptibility
Correct Answer: Light transmission / opacity
Q13. Which of the following is a key concern when using rubber stoppers with injectable products?
- Stoppers dissolve completely on contact
- Potential for extractables interacting with drug (e.g., antioxidants)
- They always improve stability
- They are immune to autoclaving effects
Correct Answer: Potential for extractables interacting with drug (e.g., antioxidants)
Q14. The primary goal of packaging validation is to:
- Minimize packaging costs regardless of performance
- Demonstrate packaging consistently meets specified requirements to protect product quality
- Avoid regulatory inspections
- Ensure packaging is the newest design only
Correct Answer: Demonstrate packaging consistently meets specified requirements to protect product quality
Q15. Which accelerated test is often used to predict long-term stability in packaging studies?
- Freeze-thaw only
- High temperature and humidity stress testing
- Visual color matching
- Mechanical drop test only
Correct Answer: High temperature and humidity stress testing
Q16. For biologics, which container attribute is especially critical to evaluate?
- UV color trim
- Protein adsorption and aggregation induced by surfaces
- Weight of the primary carton
- Barcode print quality
Correct Answer: Protein adsorption and aggregation induced by surfaces
Q17. Which is an example of a container closure integrity destructive test?
- Vacuum decay
- Helium leak using intact unit
- Dye ingress after forced leakage
- Non-invasive spectral analysis
Correct Answer: Dye ingress after forced leakage
Q18. Which documentation is essential to demonstrate regulatory compliance for packaging selection?
- Only marketing brochures
- Material specifications, stability data, extractables/leachables reports, and CCI test reports
- Employee training certificates only
- Invoice copies from suppliers only
Correct Answer: Material specifications, stability data, extractables/leachables reports, and CCI test reports
Q19. Why is headspace oxygen content important in sealed containers for oxidizable drugs?
- It affects container weight only
- Oxygen can drive oxidation and reduce shelf life
- It improves microbial growth control
- It has no influence on drug stability
Correct Answer: Oxygen can drive oxidation and reduce shelf life
Q20. Which closure material is commonly coated to minimize interactions and reduce extractables?
- Glass vials coated with silicone oil only
- Uncoated metal caps
- Lipid-coated syringes
- Rubber stoppers with fluoropolymer or polymeric barrier coatings
Correct Answer: Rubber stoppers with fluoropolymer or polymeric barrier coatings
Q21. What is the role of primary packaging in drug product stability?
- Only to display branding
- To provide direct protection against physical, chemical and biological degradation
- To increase shipping expense
- To replace quality control testing
Correct Answer: To provide direct protection against physical, chemical and biological degradation
Q22. Which test would assess microbial ingress potential of a container system?
- Microbial challenge test using standardized organisms
- pH titration
- Differential scanning calorimetry
- Viscosity measurement
Correct Answer: Microbial challenge test using standardized organisms
Q23. According to good packaging practice, labeling on primary containers must include:
- Only the company logo
- Essential identity, strength, lot number, expiry and storage conditions
- Detailed manufacturing SOPs
- Complete list of all suppliers
Correct Answer: Essential identity, strength, lot number, expiry and storage conditions
Q24. Which container choice is most suitable for highly hygroscopic powders?
- Permeable film pouches
- High-barrier containers with desiccant or tight HDPE/PET bottles
- Open trays
- Paper envelopes
Correct Answer: High-barrier containers with desiccant or tight HDPE/PET bottles
Q25. What is a common concern when using plastic containers for organic solvent-based formulations?
- Plastic may leach or swell, compromising drug purity
- They always provide superior barrier to glass
- Plastic prevents autoclaving completely
- Plastic guarantees no extractables
Correct Answer: Plastic may leach or swell, compromising drug purity
Q26. Tamper-evident seals are validated primarily by:
- Customer surveys
- Physical and functional tests demonstrating evidence of opening and resistance to undetected tampering
- Color matching tests
- Radioactivity measurements
Correct Answer: Physical and functional tests demonstrating evidence of opening and resistance to undetected tampering
Q27. Which ISO/ICH concept emphasizes evaluation based on science and risk for packaging decisions?
- Good Distribution Practice only
- Quality by Design (QbD) / Risk-based approach
- Just-In-Time manufacturing
- Lean Six Sigma exclusively
Correct Answer: Quality by Design (QbD) / Risk-based approach
Q28. For cold chain biologics, packaging must be qualified for:
- Room temperature only
- Defined temperature excursions, thermal insulation and stability under chilled/frozen conditions
- High-pressure environments only
- Radiation sterilization only
Correct Answer: Defined temperature excursions, thermal insulation and stability under chilled/frozen conditions
Q29. Which analytical approach is central to identifying unknown extractables/leachables?
- Organoleptic testing
- Hyphenated techniques like GC-MS and LC-MS with targeted and non-targeted analysis
- Simple UV-visible only
- pH strip testing
Correct Answer: Hyphenated techniques like GC-MS and LC-MS with targeted and non-targeted analysis
Q30. What is the primary reason for performing compatibility studies between drug product and container?
- To reduce manufacturing time
- To ensure no adverse chemical or physical interactions that affect safety, potency or appearance
- To increase marketing claims
- To avoid stability testing
Correct Answer: To ensure no adverse chemical or physical interactions that affect safety, potency or appearance
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.
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