Batch formula record and master formula record MCQs With Answer

Introduction

Understanding the Batch Formula Record and Master Formula Record is essential for B. Pharm students studying pharmaceutical manufacturing and GMP documentation. The master formula record (MFR) defines the approved recipe, materials, equipment, process parameters, in-process controls, and labeling instructions. The batch formula or batch manufacturing record (BMR/BFR) is the executed document capturing actual batch data, yields, deviations, and signatures for traceability and QC release. Familiarity with these records, their components, differences, reconciliation practices, and regulatory expectations strengthens competency in documentation, quality assurance, validation, and regulatory inspections. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of a Master Formula Record (MFR)?

• To record the actual manufacturing data for a single batch
• To provide an approved, detailed recipe and instructions for consistent production
• To list market distribution channels for a product
• To document finished product sales

Correct Answer: To provide an approved, detailed recipe and instructions for consistent production

Q2. What does a Batch Manufacturing Record (BMR) primarily document?

• The validated formulation to be used for all future batches
• Theoretical calculations for product registration
• The actual step-by-step actions, quantities, and measurements taken during a specific batch
• Marketing claims and dosing recommendations

Correct Answer: The actual step-by-step actions, quantities, and measurements taken during a specific batch

Q3. Which element is typically included in both MFR and BMR?

• Actual signature of the production operator only in MFR
• List of raw materials with specification references
• Sales forecast for the product
• Customer complaint logs

Correct Answer: List of raw materials with specification references

Q4. Who must approve the Master Formula Record before manufacturing begins?

• Marketing manager
• Quality assurance (QA) or designated responsible person
• Sales representative
• Customer service

Correct Answer: Quality assurance (QA) or designated responsible person

Q5. Which statement best describes the relationship between MFR and BMR?

• MFR is generated after completing the BMR
• BMR is the master document and MFR is its copy
• MFR is the approved recipe; BMR is the executed record for each batch
• They are completely unrelated documents

Correct Answer: MFR is the approved recipe; BMR is the executed record for each batch

Q6. Which of the following is an essential component of a Master Formula Record?

• Employee payroll details
• Equipment identification and cleaning requirements
• Customer order history
• Distribution route planning

Correct Answer: Equipment identification and cleaning requirements

Q7. During batch execution, a deviation from the procedure occurs. Where should this be recorded?

• Only in the operator’s personal notebook
• In the Batch Manufacturing Record with appropriate deviation documentation and investigation
• Nowhere; minor deviations can be ignored
• Only in the Master Formula Record for future use

Correct Answer: In the Batch Manufacturing Record with appropriate deviation documentation and investigation

Q8. Which entry is unique to the Batch Manufacturing Record compared to the Master Formula Record?

• Standard mixing time
• Actual quantities used and actual yield for the batch
• Approved formulation steps
• Specification references for raw materials

Correct Answer: Actual quantities used and actual yield for the batch

Q9. What is the purpose of reconciliation in a batch record?

• To reconcile accounting statements with sales
• To ensure quantities of materials used match theoretical amounts and to account for any loss
• To adjust product pricing
• To schedule the next production run

Correct Answer: To ensure quantities of materials used match theoretical amounts and to account for any loss

Q10. Which regulatory principle governs maintenance of Master and Batch records?

• Good Manufacturing Practice (GMP)
• International Financial Reporting Standards (IFRS)
• Freedom of Information Act
• Food Pyramid Guidelines

Correct Answer: Good Manufacturing Practice (GMP)

Q11. What information about packaging is expected in the MFR?

• The cost of packaging materials only
• Detailed packaging components, labeling instructions, and pack sizes
• Distributor contact details
• Retail shelf placement

Correct Answer: Detailed packaging components, labeling instructions, and pack sizes

Q12. Who is responsible for signing and releasing the finished batch for distribution?

• Production supervisor without QA review
• Quality assurance or authorized person after review of BMR and QC results
• Any operator present at shift end
• Marketing head

Correct Answer: Quality assurance or authorized person after review of BMR and QC results

Q13. How should changes to a Master Formula Record be handled?

• Altering the document without record is acceptable for small changes
• Changes must be controlled, documented, authorized, and version‑controlled
• Only verbal approvals are needed
• Changes should be made directly in executed BMRs

Correct Answer: Changes must be controlled, documented, authorized, and version‑controlled

Q14. Which of the following best defines a Batch Formula Record (BFR) in common practice?

• A financial summary of production costs
• An executed batch record documenting real-time production data for a batch
• A marketing brochure for the product
• The registration dossier submitted to regulators

Correct Answer: An executed batch record documenting real-time production data for a batch

Q15. What in‑process controls are typically documented in the BMR?

• Only final product test results
• Parameters like temperature, pH, mixing time, and sampling results at defined stages
• Customer satisfaction surveys
• Sales targets

Correct Answer: Parameters like temperature, pH, mixing time, and sampling results at defined stages

Q16. Which entry ensures traceability of raw materials in a batch record?

• Batch number of each raw material and supplier lot reference
• Operator’s home address
• Forecasted demand for raw materials
• Packaging designer name

Correct Answer: Batch number of each raw material and supplier lot reference

Q17. What is the role of SOPs in relation to Master and Batch records?

• SOPs are unrelated to batch documentation
• SOPs provide detailed operational procedures that the MFR/BMR reference and must be followed
• SOPs replace the need for MFRs
• SOPs only cover HR policies

Correct Answer: SOPs provide detailed operational procedures that the MFR/BMR reference and must be followed

Q18. Which of the following must be captured immediately in the BMR to comply with GMP?

• Corrective actions and deviations noted contemporaneously with the event
• Annual company performance reviews
• Planned vacation schedules
• Historical sales data

Correct Answer: Corrective actions and deviations noted contemporaneously with the event

Q19. When scaling a formulation from laboratory to production, what must be done in the MFR?

• Ignore scaling; use identical conditions
• Recalculate component quantities, adjust process parameters, and perform process validation
• Reduce documentation to save time
• Only change the label size

Correct Answer: Recalculate component quantities, adjust process parameters, and perform process validation

Q20. How should signatures in BMRs be handled to meet compliance?

• Initials are acceptable without dates
• Signatures and dates should be recorded by the responsible person at the time of the activity
• One signature at the end of the month is sufficient
• Electronic or handwritten signatures are banned

Correct Answer: Signatures and dates should be recorded by the responsible person at the time of the activity

Q21. Which is a common consequence of poor batch record keeping?

• Improved product variability
• Regulatory non‑compliance, product recalls, and loss of traceability
• Reduced documentation workload
• Faster market approvals

Correct Answer: Regulatory non‑compliance, product recalls, and loss of traceability

Q22. In the context of MFR/BMR, what does ‘retention period’ refer to?

• The time materials spend in quarantine
• The mandated duration records must be preserved and available for inspection
• The production lead time
• The expiry period of raw materials

Correct Answer: The mandated duration records must be preserved and available for inspection

Q23. What documentation is necessary for outsourced manufacturing in relation to MFR/BMR?

• No documentation is needed if outsourced
• A clear contract, approved MFR, batch documentation, and oversight arrangements
• Only financial invoices
• Marketing permissions only

Correct Answer: A clear contract, approved MFR, batch documentation, and oversight arrangements

Q24. Which of the following best describes ‘retrospective changes’ to a BMR?

• Permitted without record if minor
• Changes made after the batch is completed without justification or traceability, which are not acceptable
• Preferred practice for efficiency
• Only performed by production managers verbally

Correct Answer: Changes made after the batch is completed without justification or traceability, which are not acceptable

Q25. What should a Master Formula Record specify about sampling?

• Sampling frequency, sampling points, sample size, and handling instructions
• Only when to ship the product
• Marketing demographics for the product
• Employee sampling for HR

Correct Answer: Sampling frequency, sampling points, sample size, and handling instructions

Q26. Which personnel normally reviews and initials in‑process checks in the BMR?

• Only the head of sales
• The operator performing the activity and an independent checker or supervisor where required
• Customers visiting the plant
• The packaging vendor

Correct Answer: The operator performing the activity and an independent checker or supervisor where required

Q27. Why are yield calculations included in batch records?

• To estimate advertising budget
• To monitor process performance, detect losses, and support reconciliation
• To decide employee bonuses only
• To design product labels

Correct Answer: To monitor process performance, detect losses, and support reconciliation

Q28. What is the correct action if a required in‑process check is missed during manufacture?

• Continue and ignore the missing check
• Document the omission in the BMR, investigate, assess impact, and decide disposition with QA
• Have the operator vaguely note it later without details
• Delete the step from the master record

Correct Answer: Document the omission in the BMR, investigate, assess impact, and decide disposition with QA

Q29. Which item is NOT typically part of the Master Formula Record?

• Batch numbering system and traceability guidelines
• Detailed manufacturing procedure and critical parameters
• Employee medical records
• Environmental controls and special precautions

Correct Answer: Employee medical records

Q30. For regulatory inspection readiness, what is a best practice regarding MFR and BMR?

• Maintain clear, complete, contemporaneous records with referenced SOPs, approvals, and retrievable versions
• Store records only offsite without indexing
• Allow undocumented verbal approvals for speed
• Keep records unreviewed to avoid liability

Correct Answer: Maintain clear, complete, contemporaneous records with referenced SOPs, approvals, and retrievable versions

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