Audit of packaging materials MCQs With Answer

Audit of packaging materials MCQs With Answer

This set of multiple-choice questions is designed for M.Pharm students preparing for exams and practical roles in pharmaceutical quality assurance. The questions focus on auditing packaging materials — covering regulatory expectations, supplier qualification, incoming inspection, documentation, sampling, stability implications, container-closure integrity, extractables/leachables, traceability and change control. Emphasis is placed on practical audit items, critical quality attributes of packaging components, and key references from cGMP and pharmacopoeial guidance. Use these MCQs to test your understanding of both conceptual requirements and applied audit procedures that ensure packaging systems maintain drug product quality, safety and compliance throughout the supply chain.

Q1. What is the primary objective of an audit of pharmaceutical packaging materials?

• To minimize packaging costs irrespective of quality
• To ensure packaging materials comply with approved specifications, regulatory requirements and are fit for intended use
• To verify only the aesthetic appearance of packaging
• To confirm marketing preferences of the packaging design

Correct Answer: To ensure packaging materials comply with approved specifications, regulatory requirements and are fit for intended use

Q2. Which document is most critical to review when auditing incoming packaging materials?

• Employee training records
• Purchase order without specifications
• Certificate of analysis (CoA) and supplier specification
• Marketing brochures from the supplier

Correct Answer: Certificate of analysis (CoA) and supplier specification

Q3. During a supplier audit of a container-closure supplier, what is a key attribute to evaluate?

• The supplier’s social media presence
• The supplier’s process controls for dimensional and functional consistency
• The supplier’s proximity to the drug manufacturer only
• The number of brands the supplier produces

Correct Answer: The supplier’s process controls for dimensional and functional consistency

Q4. Which testing is essential to assess seal integrity of parenteral primary packaging?

• Visual inspection for color only
• Container closure integrity testing (e.g., helium leak, dye ingress, vacuum decay)
• Disintegration testing
• Friability testing

Correct Answer: Container closure integrity testing (e.g., helium leak, dye ingress, vacuum decay)

Q5. In a packaging materials audit, what does traceability typically refer to?

• Tracking the marketing claims associated with packaging
• Ability to track each batch of packaging material from supplier lot to finished drug product label
• Tracing only the shipment route of finished products
• Recording the design inspiration for packaging

Correct Answer: Ability to track each batch of packaging material from supplier lot to finished drug product label

Q6. Which regulatory requirement is directly relevant when auditing labeling materials for pharmaceuticals?

• ISO 9001 only
• Local advertising laws exclusively
• Label content must meet local regulatory labeling regulations and pharmacopoeial requirements
• Retail shelf placement guidelines

Correct Answer: Label content must meet local regulatory labeling regulations and pharmacopoeial requirements

Q7. What is the purpose of testing packaging materials for extractables and leachables (E/L)?

• To assess mechanical strength only
• To evaluate potential chemical contaminants that can migrate into the drug product and impact safety or efficacy
• To confirm package color stability in sunlight
• To determine package recyclability

Correct Answer: To evaluate potential chemical contaminants that can migrate into the drug product and impact safety or efficacy

Q8. Which audit finding would be most critical for immediate corrective action?

• Supplier uses different font on packaging artwork
• No incoming inspection records and unverified supplier CoAs for critical barrier packaging
• Late delivery of a non-critical cardboard overpack
• Minor mismatch in packing list formatting

Correct Answer: No incoming inspection records and unverified supplier CoAs for critical barrier packaging

Q9. What is an appropriate sampling plan element when auditing incoming packaging material acceptance?

• Random sample size with no written plan
• Sampling based on AQL (Acceptance Quality Limit) and risk assessment for critical attributes
• Inspecting only the first unit received
• Sampling governed solely by supplier convenience

Correct Answer: Sampling based on AQL (Acceptance Quality Limit) and risk assessment for critical attributes

Q10. Which of the following is an important consideration for packaging material storage evaluated during an audit?

• Storage area should be aesthetically pleasing
• Controlled environment conditions (temperature, humidity), segregation and FIFO traceability
• Storage close to incompatible chemicals without controls
• Maximum stacking height irrespective of label legibility

Correct Answer: Controlled environment conditions (temperature, humidity), segregation and FIFO traceability

Q11. Which document records approved packaging specifications, including materials, coatings, and tolerances?

• Batch manufacturing record for the drug substance only
• Packaging specification or master specification document
• Employee handbook
• Marketing product brief

Correct Answer: Packaging specification or master specification document

Q12. When auditing change control for packaging materials, what should the auditor verify?

• Changes are only documented for cosmetic improvements
• Changes are evaluated for quality/regulatory impact and approved prior to implementation
• Changes implemented immediately without evaluation
• Only suppliers are informed but not internal QA

Correct Answer: Changes are evaluated for quality/regulatory impact and approved prior to implementation

Q13. Which test would be most relevant for assessing moisture barrier performance of blister foil?

• Tensile strength test
• Water vapor transmission rate (WVTR) measurement
• Color fastness test
• pH measurement

Correct Answer: Water vapor transmission rate (WVTR) measurement

Q14. In an audit, which evidence demonstrates supplier qualification for critical packaging components?

• Informal verbal assurance from supplier
• Completed supplier qualification dossier including audits, technical assessments, CoAs and periodic re-evaluation
• Supplier’s statement of intent
• Low price quotations

Correct Answer: Completed supplier qualification dossier including audits, technical assessments, CoAs and periodic re-evaluation

Q15. Which principle is essential when auditing packaging used for stability studies?

• Use any available packaging so long as it looks similar
• Use packaging that matches the proposed commercial container-closure system and is fully characterized
• Use packaging chosen by marketing only
• Change packaging during study to newer designs without documentation

Correct Answer: Use packaging that matches the proposed commercial container-closure system and is fully characterized

Q16. For audit purposes, what is a critical aspect of labeling control?

• Ensuring label printers are the cheapest available
• Controls to prevent mix-ups: approved artwork, version control, issuance records, and reconciliation during use
• Allowing last-minute label text changes without approval
• Permitting manual handwriting on all production labels

Correct Answer: Controls to prevent mix-ups: approved artwork, version control, issuance records, and reconciliation during use

Q17. Which international guidance is often referenced when auditing pharmaceutical packaging materials?

• WHO Good Manufacturing Practices and ICH guidelines for stability and packaging considerations
• ISO 14001 exclusively
• Local supermarket packaging guidelines
• General trade show brochures

Correct Answer: WHO Good Manufacturing Practices and ICH guidelines for stability and packaging considerations

Q18. What role does risk assessment play in packaging material audits?

• Risk assessment is optional and rarely useful
• Helps prioritize audit focus on packaging attributes with highest impact on product quality and patient safety
• Only used to justify longer audit reports
• Determines marketing strategy for packaging

Correct Answer: Helps prioritize audit focus on packaging attributes with highest impact on product quality and patient safety

Q19. Which control is important to prevent counterfeit or misbranded packaging entering the supply chain?

• Rely solely on supplier reputation without verification
• Implement serialization, unique identifiers, and secure supply chain controls
• Use plain unmarked packaging to avoid attention
• Accept packaging from any source if the price is low

Correct Answer: Implement serialization, unique identifiers, and secure supply chain controls

Q20. When auditing documentation for packaging materials, what is expected regarding retention and accessibility?

• Retention is at supplier discretion only
• Complete records (specs, CoAs, certificates, changes) must be retained per regulatory timelines and be readily retrievable
• No records are required once material is used
• Records may be discarded after one week

Correct Answer: Complete records (specs, CoAs, certificates, changes) must be retained per regulatory timelines and be readily retrievable

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