Pharmaceutical packaging requirements for dosage forms MCQs With Answer

Introduction: Pharmaceutical packaging requirements for dosage forms MCQs With Answer is designed specifically for M.Pharm students preparing for exams in Product Development and Technology Transfer. This collection focuses on critical principles such as container-closure integrity, material compatibility, barrier properties (moisture, oxygen, light), regulatory labeling, stability-in-package, and packaging validation. Each question probes practical and regulatory aspects encountered during formulation transfer, stability studies, and manufacturing scale-up. Working through these MCQs will strengthen your ability to select appropriate packaging systems, anticipate extractables and leachables, ensure sterility and tamper evidence, and comply with ICH/FDA/EMA expectations—skills essential for successful product development and technology transfer.

Q1. What is the primary purpose of conducting container-closure integrity (CCI) testing for sterile parenteral products?

• To evaluate the drug’s potency over time
• To ensure the packaging prevents microbial ingress and maintains sterility
• To assess patient acceptability of packaging
• To measure the packaging’s thermal conductivity

Correct Answer: To ensure the packaging prevents microbial ingress and maintains sterility

Q2. Which packaging attribute is most critical for hygroscopic solid dosage forms such as efflorescent tablets?

• Transparency to visible light
• Oxygen permeability
• Water vapor transmission rate (WVTR)
• Electrostatic charge

Correct Answer: Water vapor transmission rate (WVTR)

Q3. For photolabile drugs, which packaging material property is most important?

• High tensile strength
• Opacity or UV-blocking capability
• Low cost
• Gas permeability

Correct Answer: Opacity or UV-blocking capability

Q4. Which regulatory guideline specifically addresses photostability testing relevant to packaging selection?

• ICH Q1A (R2) Stability Testing of New Drug Substances and Products
• ICH Q1B Photostability Testing of New Drug Substances and Products
• FDA cGMP 21 CFR Part 11
• ICH Q7 Good Manufacturing Practice for APIs

Correct Answer: ICH Q1B Photostability Testing of New Drug Substances and Products

Q5. Which factor is most relevant when selecting primary packaging for an aqueous oral solution sensitive to oxygen?

• Use of glass vials without headspace control
• Selection of a low oxygen transmission rate container and inert headspace
• Preference for high oxygen permeability plastics
• Avoidance of desiccants

Correct Answer: Selection of a low oxygen transmission rate container and inert headspace

Q6. What is the major concern related to extractables and leachables (E&L) in drug packaging?

• They improve drug bioavailability
• They may interact with or contaminate the drug, affecting safety and stability
• They make packaging more durable
• They reduce manufacturing cost

Correct Answer: They may interact with or contaminate the drug, affecting safety and stability

Q7. Which packaging validation activity is essential during technology transfer to a new manufacturing site?

• Only verifying the label font size
• Full-scale container-closure compatibility and integrity verification under expected process conditions
• Reducing inspection frequency arbitrarily
• Changing container vendor without qualification

Correct Answer: Full-scale container-closure compatibility and integrity verification under expected process conditions

Q8. For lyophilized injectable products, which packaging combination is typically required?

• High barrier aluminum foil sachet
• Glass vial with rubber stopper and aluminum crimp
• Plastic bottle with child-resistant cap
• Blister pack

Correct Answer: Glass vial with rubber stopper and aluminum crimp

Q9. Child-resistant packaging is most relevant to which regulatory requirement?

• Ensuring packaging is recyclable
• Preventing accidental pediatric ingestion in accordance with Poison Prevention Packaging Act (PPPA) or equivalent
• Improving product aesthetics
• Reducing package weight

Correct Answer: Preventing accidental pediatric ingestion in accordance with Poison Prevention Packaging Act (PPPA) or equivalent

Q10. Which test is commonly used to assess tamper-evident features of secondary packaging?

• Accelerated light exposure test
• Thermal conductivity measurement
• Physical tampering simulation and visual inspection for breach indication
• Headspace gas analysis for oxygen

Correct Answer: Physical tampering simulation and visual inspection for breach indication

Q11. In choosing packaging for transdermal patches, which property is crucial to maintain drug reservoir integrity?

• High oxygen permeability
• Appropriate adhesive compatibility and barrier to migration
• Transparent appearance
• High water vapor permeability

Correct Answer: Appropriate adhesive compatibility and barrier to migration

Q12. Which packaging consideration is most important for multi-dose ophthalmic solutions?

• Use of non-sterile closures to reduce cost
• Design to prevent microbial contamination during use, e.g., tip design and preservative compatibility
• Opaque packaging to hide product color
• High oxygen permeability of the bottle material

Correct Answer: Design to prevent microbial contamination during use, e.g., tip design and preservative compatibility

Q13. During accelerated stability studies, why is the chosen packaging included in testing rather than only the bulk drug product?

• Packaging only affects appearance, not stability
• Packaging can interact with the product and affect degradation pathways and shelf life
• To increase study cost
• Regulators do not require packaging in stability studies

Correct Answer: Packaging can interact with the product and affect degradation pathways and shelf life

Q14. Which container material is most suitable for high-barrier protection against moisture for blister packaging of tablets?

• PVC single-layer film
• Aluminum foil or aluminum-aluminum (cold-formed) blisters
• Polystyrene trays
• Low-density polyethylene (LDPE)

Correct Answer: Aluminum foil or aluminum-aluminum (cold-formed) blisters

Q15. What is the primary reason to include a desiccant in secondary packaging for certain solid dosage forms?

• To prevent oxidation of the drug by absorbing oxygen
• To maintain low relative humidity by absorbing moisture that could degrade hygroscopic drugs
• To act as a cushion during transportation
• To add weight to the package

Correct Answer: To maintain low relative humidity by absorbing moisture that could degrade hygroscopic drugs

Q16. Which assessment is essential to qualify a polymer container for an oral liquid formulation with an organic solvent?

• Boiling point determination of the solvent
• Compatibility testing including extractables/leachables and physical integrity
• Color matching of the polymer
• Assessment of the container’s magnetism

Correct Answer: Compatibility testing including extractables/leachables and physical integrity

Q17. What packaging feature is particularly important for powdered inhalation products to ensure dose accuracy?

• High water vapor transmission rate
• Low particulate ingress and maintenance of powder flow properties by moisture protection
• Use of colored cartons only
• Loose-fitting caps that allow air exchange

Correct Answer: Low particulate ingress and maintenance of powder flow properties by moisture protection

Q18. Which documentation is critical to include in a technology transfer package concerning packaging for regulatory submission?

• Only marketing brochures of the packaging vendor
• Detailed container-closure specifications, validation data (CCI, E&L), and stability-in-package results
• Employee CVs of packaging line operators
• Only photographs of finished cartons

Correct Answer: Detailed container-closure specifications, validation data (CCI, E&L), and stability-in-package results

Q19. Which parameter best indicates a packaging material’s resistance to oxygen permeation that could affect oxidation-prone drugs?

• Water uptake percentage
• Oxygen transmission rate (OTR)
• Glass transition temperature
• Color stability

Correct Answer: Oxygen transmission rate (OTR)

Q20. During scale-up, why must closure torque and capping parameters be validated for liquid dosage forms?

• They have no impact on product quality
• To ensure consistent seal quality, prevent leaks, and maintain container-closure integrity under shipping and storage conditions
• To speed up the packaging line regardless of seal quality
• Only to comply with marketing preferences

Correct Answer: To ensure consistent seal quality, prevent leaks, and maintain container-closure integrity under shipping and storage conditions

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