Materials system inspection MCQs With Answer

Introduction: Materials System Inspection MCQs With Answer is a focused quiz collection designed for M.Pharm students studying Quality Management Systems (MQA 102T). This set emphasizes practical and regulatory aspects of materials handling within pharmaceutical manufacturing — including receipt, sampling, quarantine, storage, documentation, supplier qualification, and release procedures. Each question challenges students to apply GMP principles, inspection techniques, and critical decision-making used by quality assurance teams. The MCQs are crafted to deepen understanding of real-world inspection scenarios, identify common compliance pitfalls, and reinforce best practices required for maintaining product integrity and traceability throughout the materials lifecycle.

Q1. What is the primary purpose of a quarantine area for received raw materials?

• To store materials that are ready for production use
• To isolate materials pending quality review and testing
• To dispose of expired materials
• To perform packaging operations

Correct Answer: To isolate materials pending quality review and testing

Q2. Which document commonly accompanies pharmaceutical raw materials and provides details on identity, purity, and potency?

• Material Safety Data Sheet
• Certificate of Analysis
• Purchase Order
• Batch Manufacturing Record

Correct Answer: Certificate of Analysis

Q3. During an inspection of incoming materials, which finding is most critical to document immediately?

• Minor labeling font differences
• Temperature excursion during transit for cold-chain material
• Presence of pallet damage
• Supplier invoice discrepancy

Correct Answer: Temperature excursion during transit for cold-chain material

Q4. What is the recommended action when a delivered material lacks a corresponding purchase order number and COA?

• Release it to production after visual inspection
• Return it to supplier without further action
• Place the material in quarantine and notify QA for investigation
• Label it as promotional sample

Correct Answer: Place the material in quarantine and notify QA for investigation

Q5. Which practice ensures traceability of materials from receipt to finished product?

• Using handwritten shorthand without record retention
• Assigning unique lot numbers and maintaining material movement logs
• Storing all materials in a single unlabeled room
• Relying on supplier phone confirmations

Correct Answer: Assigning unique lot numbers and maintaining material movement logs

Q6. Which inspection focus is most relevant for packaging component suppliers?

• Worker uniform colors
• Container closure integrity and component compatibility
• Office decor
• Supplier marketing materials

Correct Answer: Container closure integrity and component compatibility

Q7. What is a critical element of a robust supplier qualification program?

• Price negotiation only
• Initial qualification plus periodic audits and performance monitoring
• Accepting supplier brochures as sole evidence
• Exclusive reliance on third-party certification without audits

Correct Answer: Initial qualification plus periodic audits and performance monitoring

Q8. Statistical sampling plans during material inspection are primarily used to:

• Eliminate all testing costs
• Provide a risk-based approach to determine representative samples for testing
• Ensure 100% inspection of every item
• Replace the need for supplier qualification

Correct Answer: Provide a risk-based approach to determine representative samples for testing

Q9. Which of the following best describes “chain of custody” for sampled materials?

• Informal transfer without documentation
• Documented, tracked custody from sampling through testing and storage
• Single person holding the sample without signatures
• Leaving samples unattended in transit

Correct Answer: Documented, tracked custody from sampling through testing and storage

Q10. What is the role of Quality Assurance (QA) in material release?

• Only to purchase materials
• To review testing data, COA, and documentation, and formally authorize release
• To perform physical unloading at receiving dock
• To decide storage temperature arbitrarily

Correct Answer: To review testing data, COA, and documentation, and formally authorize release

Q11. Which inspection observation would indicate a problem with material storage controls?

• Materials stored according to product family and required temperature
• Expired materials mixed with usable stock on the same shelf
• Clear aisle space and proper shelving
• Calibration certificates available for temperature monitors

Correct Answer: Expired materials mixed with usable stock on the same shelf

Q12. For stability sample storage, an inspection should verify that samples are:

• Accessible to all production staff for convenience
• Clearly identified, stored under defined conditions, and logged for traceability
• Intermingled with routine production batches
• Kept without retention records

Correct Answer: Clearly identified, stored under defined conditions, and logged for traceability

Q13. Which corrective action is appropriate if routine incoming inspection frequently finds out-of-specification impurities?

• Ignore the findings and continue using materials
• Initiate supplier investigation, hold material, and perform CAPA including supplier remediation
• Reduce sampling frequency to avoid detection
• Switch to a cheaper supplier without qualification

Correct Answer: Initiate supplier investigation, hold material, and perform CAPA including supplier remediation

Q14. What inspection evidence supports that a material’s cold-chain integrity was maintained?

• Handwritten note saying “OK”
• Continuous temperature records and tamper-evident seals on shipment
• Supplier’s marketing brochure
• Unverified verbal assurance from courier

Correct Answer: Continuous temperature records and tamper-evident seals on shipment

Q15. Which practice improves reliability of incoming material identity verification?

• Relying solely on supplier name on the pallet label
• Cross-checking label information with COA, purchase order, and unique lot number
• Using batch labels from a different material
• Assuming identity based on color of packaging

Correct Answer: Cross-checking label information with COA, purchase order, and unique lot number

Q16. During inspection, what indicates adequate segregation of quarantined and released materials?

• Shared shelving with no visual distinction
• Physical barriers, clear labeling, and documented access controls
• Quarantine items stored next to finished goods
• No records showing movement between areas

Correct Answer: Physical barriers, clear labeling, and documented access controls

Q17. What is the inspector’s priority when observing evidence of contamination on incoming raw material packaging?

• Ignore it if the material looks usable
• Quarantine the shipment, document findings, and arrange microbiological/chemical investigation
• Use a portion and discard the rest
• Clean the packaging superficially and release

Correct Answer: Quarantine the shipment, document findings, and arrange microbiological/chemical investigation

Q18. Which documentation is essential to retain for audit trail of material disposition?

• Only purchase invoices
• Quarantine logs, test results, COAs, release approvals, and disposal records
• Employee lunch schedules
• Supplier general promotional emails

Correct Answer: Quarantine logs, test results, COAs, release approvals, and disposal records

Q19. Which inspection activity helps verify that rework or reprocessing of materials complies with GMP?

• Checking that rework is performed without any documentation
• Reviewing approved change control, documented procedures, testing results, and QA approval
• Allowing production manager to decide rework criteria informally
• Discarding all reworked batches without review

Correct Answer: Reviewing approved change control, documented procedures, testing results, and QA approval

Q20. What is the most important reason to calibrate temperature and humidity monitors used in material storage areas?

• To satisfy decoration standards
• To ensure environmental conditions are accurately monitored and compliant limits are maintained
• To increase electricity usage
• To allow informal logging by any staff member

Correct Answer: To ensure environmental conditions are accurately monitored and compliant limits are maintained

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