Review of production records MCQs With Answer

Review of production records MCQs With Answer is an essential resource for M.Pharm students preparing for careers in pharmaceutical Quality Control and Quality Assurance. This blog presents a focused set of multiple-choice questions that probe key aspects of production record review — including batch manufacturing records, batch packaging records, reconciliation of materials, deviation handling, investigation of OOS/OOT results, signatures and approvals, and regulatory expectations under GMP. Each question is designed to deepen conceptual understanding and practical judgment required for effective QA review. Use these MCQs to test your knowledge, identify gaps, and reinforce best practices in documentation, traceability, and compliance during pharmaceutical manufacturing.

Q1. What is the primary objective of review of production records by Quality Assurance?

• To verify the financial cost of production
• To ensure compliance with prescribed manufacturing instructions and batch documentation
• To assess employee performance during production
• To prepare marketing data for product launch

Correct Answer: To ensure compliance with prescribed manufacturing instructions and batch documentation

Q2. Which document typically serves as the stepwise guide for operators during manufacturing and is a key focus during QA review?

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR) / Production Record
• Stability protocol
• Change control form

Correct Answer: Batch Manufacturing Record (BMR) / Production Record

Q3. During review, reconciliation of raw materials is performed primarily to ensure:

• Right supplier directories are used
• Material quantities used equal materials issued, accounting for yields and losses
• Batch is released for distribution
• Packaging artwork is correct

Correct Answer: Material quantities used equal materials issued, accounting for yields and losses

Q4. If a critical deviation is found in the production record, the QA reviewer should:

• Sign the record and ignore the deviation
• Initiate or ensure a documented investigation and evaluate impact on product quality
• Return the record to production without comment
• Destroy the record to avoid regulatory scrutiny

Correct Answer: Initiate or ensure a documented investigation and evaluate impact on product quality

Q5. Which entry is expected in a production record to demonstrate personnel accountability?

• Handwritten initials or signatures with timestamps for critical operations
• Only department name without signature
• Supervisor’s verbal confirmation
• Automated printouts without operator identification

Correct Answer: Handwritten initials or signatures with timestamps for critical operations

Q6. What should QA verify about in-process test results recorded in the production record?

• That results are within specified acceptance criteria and any OOS/OOT are addressed
• That all numbers are rounded to whole units
• That tests were performed once at the end of the campaign only
• That raw instrument printouts are discarded

Correct Answer: That results are within specified acceptance criteria and any OOS/OOT are addressed

Q7. Which of the following best describes retrospective review of production records?

• Review performed during production by operators
• Detailed QA review after completion of the batch before final release
• Inspection of historical marketing data
• Review of supplier invoices after purchase

Correct Answer: Detailed QA review after completion of the batch before final release

Q8. When reconciliation shows an unexplained material shortage beyond established limits, the QA reviewer should:

• Adjust the records to hide the discrepancy
• Investigate, document root cause, evaluate product quality impact, and initiate corrective action
• Ignore if shortage is small
• Release the batch to expedite supply

Correct Answer: Investigate, document root cause, evaluate product quality impact, and initiate corrective action

Q9. Which regulatory concept requires that production records be complete, legible, and contemporaneously documented?

• Good Documentation Practice (GDP) / ALCOA principles
• Patent law
• Marketing authorization
• Environmental protection norms

Correct Answer: Good Documentation Practice (GDP) / ALCOA principles

Q10. How should QA treat entries made after the fact when reviewing a production record?

• Accept them without question if they appear correct
• Ensure late entries are clearly dated, signed, and explained as late entries per GDP
• Erase the original entry and replace it
• Require photocopying the page and then altering it

Correct Answer: Ensure late entries are clearly dated, signed, and explained as late entries per GDP

Q11. Which of the following is NOT a typical element QA checks in a batch packaging record (BPR)?

• Packaging materials reconciliation
• Labeling and artwork verification
• Environmental monitoring trend for unrelated product family
• Operator signatures at critical steps

Correct Answer: Environmental monitoring trend for unrelated product family

Q12. What is the purpose of linking Certificates of Analysis (CoA) for raw materials to batch records during review?

• To confirm vendor payment details
• To ensure materials used met specified identity, purity, and quality before use
• To record shelf placement information
• To check marketing claims

Correct Answer: To ensure materials used met specified identity, purity, and quality before use

Q13. If a microbial contamination is discovered post-production, QA review of records must include:

• Only checking the final product label
• Assessment of all related production, cleaning, environmental, and sampling records and initiating investigation
• Releasing other batches without review
• Discarding all records to prevent panic

Correct Answer: Assessment of all related production, cleaning, environmental, and sampling records and initiating investigation

Q14. During a review, an analyst notes that the actual yield is significantly higher than theoretical yield. The QA action should be:

• Approve release immediately since higher yield is beneficial
• Query production for explanation, assess sampling/assay accuracy, and investigate potential data errors or contamination
• Ignore as yield variation is common
• Change the theoretical yield in the SOP

Correct Answer: Query production for explanation, assess sampling/assay accuracy, and investigate potential data errors or contamination

Q15. Which of the following indicates proper linkage between production record review and product release?

• The QA reviewer signs and dates the batch record after satisfactory review and ensures all deviations are closed or risk-assessed
• QA stamps “Reviewed” without evidence of review
• Production manager approves the record without QA involvement
• Batch is released based solely on production’s verbal confirmation

Correct Answer: The QA reviewer signs and dates the batch record after satisfactory review and ensures all deviations are closed or risk-assessed

Q16. What is the significance of trend review of production records in QA?

• To create monthly marketing reports
• To identify recurring issues, systemic failures, or drift in processes that require CAPA
• To increase production speed regardless of quality
• To reduce record keeping

Correct Answer: To identify recurring issues, systemic failures, or drift in processes that require CAPA

Q17. Which action is appropriate when signatures are missing for critical operations in a completed production record?

• Forge the signature to complete the file
• Query the responsible person, add a documented late entry with signature and explanation, and assess impact
• Approve the batch without signatures
• Destroy the record and re-create it

Correct Answer: Query the responsible person, add a documented late entry with signature and explanation, and assess impact

Q18. Which of the following best describes an Out-of-Specification (OOS) result handling in relation to production record review?

• OOS results should be recorded and ignored if within production variation
• OOS requires immediate notification, investigation, possible product hold, and documentation of the investigation in records
• OOS is only a laboratory responsibility and not relevant to production records
• OOS results allow batch release if trending looks acceptable

Correct Answer: OOS requires immediate notification, investigation, possible product hold, and documentation of the investigation in records

Q19. During review, QA finds that a calibration certificate for a critical weighing balance is expired. The correct QA response is:

• Proceed with release since balancing was done
• Hold batch, investigate potential impact on weight-based operations, assess need for retesting or reprocessing, and document actions
• Ignore the calibration because balances seldom drift
• Replace the certificate with one from a different balance

Correct Answer: Hold batch, investigate potential impact on weight-based operations, assess need for retesting or reprocessing, and document actions

Q20. Which practice ensures integrity of electronic production records during QA review?

• Allowing unrestricted access to all staff for editing
• Use of validated electronic systems with audit trails, access controls, and data backup
• Printing and discarding original electronic records
• Turning off audit trail to simplify review

Correct Answer: Use of validated electronic systems with audit trails, access controls, and data backup

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