Batch review and batch release MCQs With Answer

This blog provides a focused set of multiple-choice questions on batch review and batch release tailored for M.Pharm students studying Quality Management Systems (MQA 102T). It covers core principles such as the responsibilities of quality assurance, documentation and batch records, in-process controls, out-of-specification handling, stability considerations, regulatory expectations, and disposition decisions. Each question is designed to test applied knowledge needed for real-world batch disposition and regulatory compliance. Answers are provided to aid self-assessment and revision. Use these MCQs to strengthen understanding of how a robust batch review and release process ensures product quality, patient safety, and regulatory conformity.

Q1. What is the primary objective of a formal batch review before release?

• To ensure cost-effectiveness of production
• To verify that all quality and regulatory requirements have been met
• To sign off on marketing strategies
• To schedule future production runs

Correct Answer: To verify that all quality and regulatory requirements have been met

Q2. Which document must be completed and reviewed prior to batch release?

• Master Production Schedule
• Batch Manufacturing Record (BMR) / Batch Packaging Record (BPR)
• Purchase order for raw materials
• Training attendance sheet

Correct Answer: Batch Manufacturing Record (BMR) / Batch Packaging Record (BPR)

Q3. Who is typically responsible for the final batch release in regulated pharmaceutical environments?

• Production supervisor
• Quality Assurance (QA) authorized person
• Head of Marketing
• Warehouse manager

Correct Answer: Quality Assurance (QA) authorized person

Q4. During batch review, which of the following is a critical review point?

• Employee attendance
• Deviation investigations and their quality impact assessment
• Office stationery inventory
• Supplier advertising materials

Correct Answer: Deviation investigations and their quality impact assessment

Q5. Which action is appropriate if a finished batch has an OOS analytical result that cannot be scientifically justified?

• Release the batch with a label warning
• Quarantine the batch and initiate a thorough investigation
• Mix the batch with another to dilute the OOS result
• Dispose the OOS data and proceed with release

Correct Answer: Quarantine the batch and initiate a thorough investigation

Q6. What is the purpose of a certificate of analysis (CoA) in the batch release process?

• To detail the manufacturing steps
• To provide the analytical test results and confirm specification compliance
• To list the manufacturing personnel
• To serve as an invoice for the customer

Correct Answer: To provide the analytical test results and confirm specification compliance

Q7. Which of the following should be reviewed regarding raw materials during batch review?

• Supplier logo design
• Certificates of analysis, expiry dates, and quarantine status
• Raw material storage location distance from office
• Price fluctuations over the past year

Correct Answer: Certificates of analysis, expiry dates, and quarantine status

Q8. What distinguishes batch release from batch review?

• Batch release is a regulatory activity; batch review is an accounting activity
• Batch review is evaluation of records; batch release is formal authorization to distribute
• They are identical processes with different names
• Batch release involves production planning only

Correct Answer: Batch review is evaluation of records; batch release is formal authorization to distribute

Q9. Which is a common reason QA may withhold release of a batch?

• Completed documentation with all approvals
• Outstanding critical deviations or incomplete investigations
• Excess inventory in warehouse
• High profitability on the batch

Correct Answer: Outstanding critical deviations or incomplete investigations

Q10. In case of a product stability failure identified after release, what is an essential step for the manufacturer?

• Ignore the failure if sales are strong
• Conduct risk assessment, notify regulatory authorities if required, and consider recall or corrective actions
• Immediately change the product label to hide the failure
• Increase production to compensate

Correct Answer: Conduct risk assessment, notify regulatory authorities if required, and consider recall or corrective actions

Q11. What role do trend analyses play in batch review and batch release?

• They are only useful for marketing
• They help detect process drifts and recurring quality issues before release
• They replace batch testing requirements
• They are irrelevant to quality management

Correct Answer: They help detect process drifts and recurring quality issues before release

Q12. For sterile products, an important batch release consideration unique to sterility is:

• Packaging color selection
• Environmental monitoring and aseptic process control records
• Office cleanliness
• Sales territory mapping

Correct Answer: Environmental monitoring and aseptic process control records

Q13. Which is the best description of a conditional release (e.g., pending results)?

• Immediate distribution without any checks
• Temporary release allowing limited distribution under strict controls while certain tests are pending
• Release after full market launch
• A marketing authorization process

Correct Answer: Temporary release allowing limited distribution under strict controls while certain tests are pending

Q14. When reviewing batch records, what is the significance of electronic records integrity?

• It is unrelated to regulatory compliance
• Ensures traceability, prevents unauthorized changes, and supports reliable batch release decisions
• Only IT staff need to be concerned
• Only relevant for financial data

Correct Answer: Ensures traceability, prevents unauthorized changes, and supports reliable batch release decisions

Q15. Which action is required if a critical deviation is discovered after a batch has been released?

• Do nothing since the batch is already released
• Perform a post-release investigation, assess impact, notify stakeholders, and take corrective action which may include recall
• Delete the deviation record
• Issue more batches to hide the problem

Correct Answer: Perform a post-release investigation, assess impact, notify stakeholders, and take corrective action which may include recall

Q16. How should out-of-specification (OOS) results be handled during batch review?

• Document, investigate scientifically, and decide disposition based on investigation findings
• Assume laboratory error and ignore the result
• Release the batch immediately
• Blame the supplier without investigation

Correct Answer: Document, investigate scientifically, and decide disposition based on investigation findings

Q17. Which of the following is a key element of a batch release decision record?

• Forecasted sales figures
• Signature and date of authorized QA person with rationale for release or rejection
• Employee birthdays
• Supplier marketing brochures

Correct Answer: Signature and date of authorized QA person with rationale for release or rejection

Q18. What is retrospective batch review and when is it commonly applied?

• Reviewing market trends retrospectively; used in sales only
• Periodic review of previously released batches’ quality data to identify trends; used as part of ongoing product quality monitoring
• Reviewing expired batches for disposal planning only
• Scheduling future production retrospectively

Correct Answer: Periodic review of previously released batches’ quality data to identify trends; used as part of ongoing product quality monitoring

Q19. Which regulatory expectation applies to the documentation of batch release activities?

• Documents should be kept only if convenient
• Complete, accurate, and readily retrievable records must be maintained for the required retention period
• Only electronic records are acceptable
• Records can be destroyed after one month

Correct Answer: Complete, accurate, and readily retrievable records must be maintained for the required retention period

Q20. What is the appropriate disposition for a batch found to contain a critical impurity above specification during review?

• Release with reduced price
• Quarantine and likely reject or rework only if scientifically justified and approved by QA and regulatory requirements
• Mix with a compliant batch without documentation
• Sell as a research-only product without disclosure

Correct Answer: Quarantine and likely reject or rework only if scientifically justified and approved by QA and regulatory requirements

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