Batch Formula Record (BFR) MCQs With Answer

Introduction: Batch Formula Record (BFR) MCQs With Answer

This set of multiple-choice questions is designed specifically for M.Pharm students to deepen understanding of Batch Formula Records (BFR) within Quality Control & Quality Assurance. The BFR is a critical GMP document that translates the Master Formula into a batch‑specific, executable manufacturing record, capturing raw material lot numbers, equipment IDs, stepwise operations, in‑process controls, yield calculations, deviations, and signatures. These MCQs probe both conceptual and practical aspects — from documentation requirements, reconciliation and retention, to handling deviations, reprocessing, and release criteria — preparing students for real‑world pharmaceutical manufacturing and regulatory inspections.

Q1. What is the primary purpose of a Batch Formula Record (BFR)?

• To serve as an internal audit checklist for quality assurance
• To provide batch‑specific, stepwise instructions and a record of execution for manufacturing a defined batch
• To list only the suppliers and purchase orders for raw materials
• To document stability data and long‑term storage conditions

Correct Answer: To provide batch‑specific, stepwise instructions and a record of execution for manufacturing a defined batch

Q2. Which element is NOT typically required in a BFR?

• Batch number and manufacturing date
• Lot numbers of raw materials used
• Pharmacovigilance safety reports
• Equipment identification and cleaning status

Correct Answer: Pharmacovigilance safety reports

Q3. How does a Master Formula differ from a Batch Formula Record (BFR)?

• Master Formula is batch‑specific; BFR is a generic authorized document
• Master Formula is an approved standard recipe; BFR is the batch‑specific record filled during production
• Master Formula contains only quality control tests; BFR contains only procurement details
• They are identical and interchangeable terms

Correct Answer: Master Formula is an approved standard recipe; BFR is the batch‑specific record filled during production

Q4. Which of the following is a critical requirement for entries made in a BFR during manufacturing?

• Entries may be backdated when convenient
• All entries should be made in indelible ink, signed or initialed, dated and timed
• Electronic entries may be anonymous without audit trail
• Handwritten corrections should be obliterated with correction fluid

Correct Answer: All entries should be made in indelible ink, signed or initialed, dated and timed

Q5. When a deviation from the BFR occurs during a critical process step, the immediate action should be:

• Ignore the deviation if final product testing passes
• Record the deviation, stop or contain the process if necessary, and notify QA for investigation
• Physically change the record to match what was done without documentation
• Resume operations and document the deviation only at batch release

Correct Answer: Record the deviation, stop or contain the process if necessary, and notify QA for investigation

Q6. Which entry in the BFR directly supports batch traceability in a recall situation?

• Description of the manufacturing facility layout
• Raw material supplier names without lot numbers
• Raw material lot numbers, equipment IDs and finished product batch number
• Employee personal addresses

Correct Answer: Raw material lot numbers, equipment IDs and finished product batch number

Q7. What is the acceptable way to make a correction in a paper BFR according to GMP?

• Erase the original entry with a razor and write the correct entry
• Use correction fluid to hide the mistake and rewrite
• Draw a single line through the error, write the correct entry nearby, initial, date and provide reason if needed
• Rewrite the entire page from scratch to avoid any visible changes

Correct Answer: Draw a single line through the error, write the correct entry nearby, initial, date and provide reason if needed

Q8. In a BFR, reconciliation of expected vs actual yield is important because:

• It is only used for cost accounting and has no quality significance
• Yield discrepancies may indicate process loss, sampling errors, or potential contamination and must be investigated
• It allows arbitrary disposal of extra material without documentation
• It replaces the need for in‑process controls

Correct Answer: Yield discrepancies may indicate process loss, sampling errors, or potential contamination and must be investigated

Q9. Which signature is mandatory before a finished batch can be released to the market?

• Production operator’s signature only
• Quality Assurance (QA) authorized person’s release signature after review
• Signature of the raw material supplier
• Signature of the packaging vendor representative

Correct Answer: Quality Assurance (QA) authorized person’s release signature after review

Q10. Which of the following should be retained as part of BFR retention sample practices?

• No samples are required to be retained once released
• Representative retained sample(s) of finished product with clear labeling, stored under defined conditions for the retention period
• Only photographs of the finished product packaging
• Unused raw material containers only

Correct Answer: Representative retained sample(s) of finished product with clear labeling, stored under defined conditions for the retention period

Q11. Which information about in‑process controls (IPCs) must be recorded in the BFR?

• Only the IPC limits but not the results
• IPC test performed, acceptance criteria, results, time and person performing the test
• IPC schedules without actual measurements
• Only final product QC results are required, not IPCs

Correct Answer: IPC test performed, acceptance criteria, results, time and person performing the test

Q12. For electronic BFR systems, which feature is essential to comply with GMP documentation requirements?

• Ability to print colorful charts for management
• Audit trails that record who made each change, when and why, with secure access controls
• Unlimited simultaneous anonymous logins for convenience
• Automatic deletion of old records to save storage

Correct Answer: Audit trails that record who made each change, when and why, with secure access controls

Q13. Which statement about reprocessing and its documentation in a BFR is correct?

• Reprocessing steps can be performed without QA approval if urgent
• Reprocessing must be pre‑approved in the Master Formula or controlled via documented deviation with QA approval and recorded in the BFR
• Reprocessing is prohibited under all circumstances
• Reprocessing requires only verbal approval recorded later

Correct Answer: Reprocessing must be pre‑approved in the Master Formula or controlled via documented deviation with QA approval and recorded in the BFR

Q14. Which of the following best describes the required relationship between calibration records and BFR entries?

• Calibration records are not relevant to the BFR
• Equipment used in critical steps must have current calibration/qualification, and the BFR should reference equipment ID so QA can verify calibration status
• Only a verbal confirmation of calibration is sufficient
• Calibration is only required for laboratory instruments, not manufacturing equipment

Correct Answer: Equipment used in critical steps must have current calibration/qualification, and the BFR should reference equipment ID so QA can verify calibration status

Q15. Which action is appropriate when excess intermediate material is generated during manufacturing and must be handled?

• Dispose of excess immediately without documentation
• Record the quantity and disposition in the BFR, investigate cause and obtain QA approval for reuse or disposal
• Mix the excess into the next batch without notification
• Return the excess to the raw material supplier

Correct Answer: Record the quantity and disposition in the BFR, investigate cause and obtain QA approval for reuse or disposal

Q16. During an inspection, a regulator asks to see the BFR for a released batch. Which of the following must the BFR include for demonstration of compliance?

• Only the original Master Formula, not the batch record
• Complete entries showing raw material lot numbers, IPC results, yield reconciliation, deviations and QA release signature
• Only photographs of production operators
• A summary page without signatures or dates

Correct Answer: Complete entries showing raw material lot numbers, IPC results, yield reconciliation, deviations and QA release signature

Q17. How should outsourced manufacturing steps be recorded in the BFR?

• Outsourced steps should be omitted from the BFR since they occur off‑site
• Detail the outsourced activity, provide supplier batch identifiers, certificates of analysis and evidence of acceptance, and record responsibility and QA review
• Mention only the contract manufacturer’s name without batch details
• Record as a single line: “outsourced” without further documentation

Correct Answer: Detail the outsourced activity, provide supplier batch identifiers, certificates of analysis and evidence of acceptance, and record responsibility and QA review

Q18. What is the typical retention period consideration for BFRs and associated batch records?

• Retention only until product expiry date and then disposal is mandatory
• Retention period should consider product shelf life, regulatory requirements and potential litigation; often several years beyond expiry as per regulations
• Record retention is not required once QA releases the batch
• Retention for one month is sufficient for all products

Correct Answer: Retention period should consider product shelf life, regulatory requirements and potential litigation; often several years beyond expiry as per regulations

Q19. Which entry in the BFR helps detect cross‑contamination between campaigns or products?

• Operator job descriptions
• Equipment cleaning records, change‑over logs and dedicated equipment ID entries
• Billing invoices for raw material purchases
• Marketing authorization holder contact details

Correct Answer: Equipment cleaning records, change‑over logs and dedicated equipment ID entries

Q20. What should be done if a critical instrument printout referenced in the BFR is missing after production?

• Proceed with QA release without the printout since tests passed
• Record the absence as a discrepancy, investigate cause, attempt to retrieve or reconstruct evidence, and document the outcome before release
• Recreate the printout manually from memory
• Ignore the missing printout and file a new BFR

Correct Answer: Record the absence as a discrepancy, investigate cause, attempt to retrieve or reconstruct evidence, and document the outcome before release

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