Master formula record MCQs With Answer

Master formula record MCQs With Answer helps M. Pharm students strengthen their understanding of this core GMP document used across pharma manufacturing and regulatory affairs. The Master Formula Record (MFR)—also called Master Production and Control Record—defines the “recipe” for a product: materials with quantities (including overages), equipment, detailed processing steps, in-process controls and limits, yields, sampling, packaging/labeling instructions, and approvals. It is central to batch consistency, traceability, and compliance with 21 CFR 211, EU GMP, ICH Q7 (for APIs), and related standards. This quiz focuses on structure, content, controls, approvals, change management, electronic systems, and inspection expectations, with scenario-based items to test applied understanding. Use it to prepare for exams and real-world GMP roles.

Q1. What is the primary objective of a Master Formula Record (MFR) in pharmaceutical manufacturing?

• To ensure each batch is manufactured consistently as per the validated process
• To track market complaint trends for management review
• To determine annual production forecasts
• To record calibration data of quality control instruments

Correct Answer: To ensure each batch is manufactured consistently as per the validated process

Q2. Which specific U.S. regulation details the requirements for Master production and control records?

• 21 CFR 211.186
• 21 CFR 210.3(b)(15)
• ICH Q9
• ISO 13485

Correct Answer: 21 CFR 211.186

Q3. Which of the following is a mandatory element in an MFR?

• List of all components with accurate weights/measures, including any justified overages
• Supplier corporate social responsibility (CSR) policies
• Daily production shift schedule
• Summary of product stability trending

Correct Answer: List of all components with accurate weights/measures, including any justified overages

Q4. Which statement best differentiates an MFR from a Batch Manufacturing/Production Record (BMR/BPR)?

• The MFR is the approved template; the BMR/BPR is the executed, filled-in record for a specific batch
• The MFR is only for QC testing; the BMR is for manufacturing
• The MFR is optional; the BMR is mandatory
• The MFR is used only for packaging; the BMR is used only for granulation

Correct Answer: The MFR is the approved template; the BMR/BPR is the executed, filled-in record for a specific batch

Q5. When revising an MFR, which governance process is expected under GMP?

• Formal change control with impact assessment and version control
• Untracked edits by production to improve efficiency
• Verbal approval by QA followed by immediate use
• Updating only the date without re-approval

Correct Answer: Formal change control with impact assessment and version control

Q6. What yield information should an MFR include at appropriate stages?

• Theoretical yields and expected yield ranges with acceptable limits at defined stages
• Only the final packed yield, without intermediate stage yields
• Only actual yields from previous commercial batches
• No yield data to avoid operator bias

Correct Answer: Theoretical yields and expected yield ranges with acceptable limits at defined stages

Q7. How should raw material quantities be specified in an MFR?

• As weight or measure for the specified batch size, clearly indicating any overages
• Only as percentages of the final product weight
• By referring only to supplier catalog codes
• By approximate volumes rounded to the nearest liter

Correct Answer: As weight or measure for the specified batch size, clearly indicating any overages

Q8. Under ICH Q7 (APIs), the MFR is most closely equivalent to which term?

• Master Production Instructions
• Analytical Method Validation Report
• Annual Product Quality Review
• Validation Master Plan

Correct Answer: Master Production Instructions

Q9. Which control is typically required in the MFR before starting a processing step to prevent mix-ups?

• Line clearance of area and equipment, documented and verified
• Verbal confirmation of material availability
• Post-process reconciliation only
• Electronic time-stamp without checks

Correct Answer: Line clearance of area and equipment, documented and verified

Q10. For an electronic MFR (eMFR), which compliance requirement is most appropriate?

• Validated system compliant with 21 CFR Part 11/Annex 11 for electronic records and signatures
• Password protection only, without validation
• Local spreadsheet files with manual signatures
• No additional controls beyond paper MFR expectations

Correct Answer: Validated system compliant with 21 CFR Part 11/Annex 11 for electronic records and signatures

Q11. Which is the best practice approval flow for an MFR?

• Prepared by Production, reviewed by Production/QC, and approved by Quality Assurance
• Prepared and approved solely by Production
• Prepared by QC, approved by Maintenance
• Prepared by Regulatory Affairs, approved by Marketing

Correct Answer: Prepared by Production, reviewed by Production/QC, and approved by Quality Assurance

Q12. Which of the following is NOT typically part of an MFR?

• Packaging and labeling instructions with specimen labels
• In-process controls with acceptance criteria
• Equipment list and critical settings
• Annual Product Review trend charts

Correct Answer: Annual Product Review trend charts

Q13. Why does the MFR require reconciliation instructions for yields and printed components?

• To compare theoretical versus actual quantities and detect discrepancies/mix-ups
• To accelerate batch release without checks
• To reduce the number of in-process tests
• To allow reuse of excess printed materials without control

Correct Answer: To compare theoretical versus actual quantities and detect discrepancies/mix-ups

Q14. What is the correct approach for controlling current and superseded versions of an MFR?

• Maintain both current and superseded versions under document control with defined retention
• Delete all superseded versions immediately
• Allow uncontrolled photocopies on the shop floor
• Maintain only the first issued version indefinitely

Correct Answer: Maintain both current and superseded versions under document control with defined retention

Q15. Which document numbering approach aligns with GMP best practice for MFRs?

• Unique identifier incorporating product code, dosage form/strength, batch size, and revision
• Random numbers assigned by operators
• Using only the issue date as the identifier
• Sequential numbers reused across products

Correct Answer: Unique identifier incorporating product code, dosage form/strength, batch size, and revision

Q16. Which is an example of an in-process control that should be specified with limits in an MFR for tablets?

• Blend uniformity acceptance: RSD NMT 5% across n=10 locations
• Annual stability testing at 25°C/60% RH
• Market release sign-off by sales
• Supplier qualification questionnaire

Correct Answer: Blend uniformity acceptance: RSD NMT 5% across n=10 locations

Q17. For a sterile product, which parameter set is expected in the MFR?

• Sterilization cycle parameters (e.g., F0/SAL targets, time, temperature, pressure)
• Shipping lane temperature excursions
• Marketing artwork approval history
• Sales forecast by region

Correct Answer: Sterilization cycle parameters (e.g., F0/SAL targets, time, temperature, pressure)

Q18. When maintained separately, which document specifically defines packaging and labeling operations/materials?

• Master Packaging Record (or Master Packaging and Control Record)
• User Requirement Specification
• Cleaning Validation Protocol
• Corrective Action and Preventive Action (CAPA)

Correct Answer: Master Packaging Record (or Master Packaging and Control Record)

Q19. Which change to an MFR most likely requires process revalidation and potential regulatory notification?

• Change in granulation solvent from isopropyl alcohol to ethanol
• Typographical correction in a heading
• Pagination format update
• Font size change for readability

Correct Answer: Change in granulation solvent from isopropyl alcohol to ethanol

Q20. If scaling to a new authorized batch size, which approach aligns with GMP for MFR control?

• Create a separate approved MFR (or a size-independent master with validated calculation sheets) before manufacture
• Let operators calculate on-the-fly and write figures in the BMR without approval
• Proceed with the old MFR and reconcile later
• Use verbal instructions to adjust quantities

Correct Answer: Create a separate approved MFR (or a size-independent master with validated calculation sheets) before manufacture

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