Master Formula Record (MFR) MCQs With Answer

Master Formula Record (MFR) MCQs With Answer is a focused quiz set designed for M.Pharm students preparing for Quality Control & Quality Assurance examinations and practical GMP responsibilities. This collection emphasizes the structure, purpose, regulatory expectations, and critical contents of a Master Formula Record — the authoritative document that defines formulation, quantities, processing steps, in‑process controls, equipment, and acceptance criteria for each product batch. Questions cover batch sizing, scaling, yield calculations, documentation requirements, deviations, release criteria, and the distinction between master and batch documents. The aim is to deepen conceptual understanding and application of MFRs in real manufacturing and regulatory contexts, strengthening both theoretical knowledge and practical QA/QC decision-making.

Q1. Which of the following best describes the primary purpose of a Master Formula Record (MFR)?

• To record the results of finished product quality tests for each batch
• To provide a detailed, approved recipe and processing instructions for consistent manufacture of each product
• To list only the raw material suppliers and their contact details
• To document cleaning validation protocols for equipment

Correct Answer: To provide a detailed, approved recipe and processing instructions for consistent manufacture of each product

Q2. Which element is NOT typically required in an MFR?

• Batch size and scaling instructions
• Equipment identification and set‑up parameters
• Employee salaries and shift schedules
• In‑process control (IPC) tests and acceptance criteria

Correct Answer: Employee salaries and shift schedules

Q3. The MFR states API quantity as 2.5% w/w for a 100 kg batch. What is the API quantity required?

• 0.25 kg
• 2.5 kg
• 25 kg
• 0.025 kg

Correct Answer: 2.5 kg

Q4. Which document is a working copy derived from the Master Formula Record used during an actual production run?

• Standard Operating Procedure (SOP)
• Batch Manufacturing Record (BMR) or Batch Production Record (BPR)
• Certificate of Analysis (CoA)
• Purchase Order

Correct Answer: Batch Manufacturing Record (BMR) or Batch Production Record (BPR)

Q5. For scale‑up from a laboratory formula to commercial batch, which instruction should be explicitly included in the MFR?

• Exact room temperature of the analytical lab
• Scale‑dependent mixing time, speed and critical process parameter limits
• Names of technicians who performed lab development
• Vendor advertisements for excipients

Correct Answer: Scale‑dependent mixing time, speed and critical process parameter limits

Q6. Which of the following is a critical in‑process control (IPC) often specified in the MFR for granulation?

• Ambient corridor cleaning schedule
• Granule moisture content or endpoint of granulation
• Marketing claims for the finished product
• Supplier invoice numbers

Correct Answer: Granule moisture content or endpoint of granulation

Q7. The MFR lists an overage of 2% for an API due to assay loss during processing. This instruction is an example of:

• A stability specification
• An allowance for processing losses to ensure label claim
• A cleaning validation limit
• A packaging change control

Correct Answer: An allowance for processing losses to ensure label claim

Q8. Which regulatory requirement most directly mandates that MFRs be prepared and followed for pharmaceutical manufacture?

• Good Laboratory Practice (GLP)
• Good Manufacturing Practice (GMP)
• ISO 9001 alone
• Pesticide regulations

Correct Answer: Good Manufacturing Practice (GMP)

Q9. A Master Formula Record must include specification for finished product release tests. Which of the following would be considered a release test?

• Disintegration time for immediate‑release tablets
• Raw material receiving inspection checklist
• Supplier audit frequency
• Staff training records

Correct Answer: Disintegration time for immediate‑release tablets

Q10. When an MFR is revised, which practice is most appropriate to maintain compliance?

• Make changes directly in the old printed copies without approval
• Use a controlled change procedure with justification, impact assessment, and approved revision history
• Ask the production supervisor to verbally inform operators
• Replace the MFR only after a year without documentation

Correct Answer: Use a controlled change procedure with justification, impact assessment, and approved revision history

Q11. Which entry in the MFR helps ensure traceability of individual raw materials used in a specific batch?

• Supplier marketing brochure
• Lot number and certificate of analysis (CoA) for each raw material
• Employee initials without timestamps
• Generic description of raw material only

Correct Answer: Lot number and certificate of analysis (CoA) for each raw material

Q12. Yield calculations in the MFR are used to:

• Determine the retirement plan for equipment
• Track material loss/waste and confirm production efficiency against theoretical expectations
• Calculate employee bonuses unrelated to production
• Estimate marketing distribution channels

Correct Answer: Track material loss/waste and confirm production efficiency against theoretical expectations

Q13. Which of the following is TRUE about the signatures required on an MFR/BPR?

• Only the production manager needs to sign the MFR
• Signatures should include the person who performed the operation and an independent reviewer who checked the operation
• Digital signatures are never acceptable
• Signatures can be added days later without dates

Correct Answer: Signatures should include the person who performed the operation and an independent reviewer who checked the operation

Q14. In case of a critical deviation during manufacture, the MFR should instruct operators to:

• Ignore the deviation and continue production
• Record the deviation immediately, stop if necessary, and notify QA for investigation
• Dispose of the batch without documentation
• Delay recording until the end of the shift

Correct Answer: Record the deviation immediately, stop if necessary, and notify QA for investigation

Q15. Which statement correctly differentiates a Master Formula Record (MFR) from a Manufacturing Formula (MF) or BMR?

• The MFR is the approved master document; the BMR is the batch‑specific working copy used during production
• They are identical and interchangeably used without version control
• MFR contains only QC test results while BMR lists supplier addresses
• BMR is only used for clinical trial materials and not for commercial batches

Correct Answer: The MFR is the approved master document; the BMR is the batch‑specific working copy used during production

Q16. Which of these parameters would you classify as a Critical Process Parameter (CPP) to be controlled in the MFR for tablet compression?

• Operator’s favorite music playlist
• Compression force and tablet weight variation limits
• Parking availability for staff
• Printer toner color for labels

Correct Answer: Compression force and tablet weight variation limits

Q17. Retention sample instructions in the MFR are important because they:

• Allow marketing to display product samples
• Provide material for stability and investigation if quality issues arise after release
• Are used exclusively to audit supplier facilities
• Are required only for controlled substances

Correct Answer: Provide material for stability and investigation if quality issues arise after release

Q18. An MFR specifies labeling instructions including identification labels for intermediate containers. The primary reason is to:

• Enhance aesthetic appeal of the production floor
• Prevent mix‑ups and ensure correct identity during processing and transfer
• Meet marketing department preferences
• Reduce the need for SOPs

Correct Answer: Prevent mix‑ups and ensure correct identity during processing and transfer

Q19. Which of the following best describes allowable weight variation instructions in the MFR for tablets?

• Arbitrary numbers chosen by production staff
• Limits based on pharmacopeial specifications or validated product requirements used as IPCs
• Always ±50% irrespective of tablet strength
• Not required because potency is controlled by assay only

Correct Answer: Limits based on pharmacopeial specifications or validated product requirements used as IPCs

Q20. During a product recall investigation, which MFR element is most critical to reconstruct exactly what was manufactured?

• The original manuscript used during formulation research
• Batch Production Record entries including actual component weights, equipment IDs, times, and operator signatures
• The marketing launch presentation
• Staff vacation records for the month

Correct Answer: Batch Production Record entries including actual component weights, equipment IDs, times, and operator signatures

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