MCQ about Master Formulation Record

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#1. What is the primary objective of preparing a Master Formula Record (MFR)?

#2. Which of the following statements about MFR preparation is CORRECT?

#3. You are preparing the MFR for a new tablet formulation. The R&D department provided the final approved formula. What should be your next step?

#4. Which of the following is NOT typically included in a Master Formula Record?

#5. In MFR preparation, the _______________ is responsible for reviewing and authorizing the document before use.

#6. True or False: The MFR must be revised every time a batch is manufactured.

#7. Which of the following elements must be included in an MFR? (Select all that apply)

#8. Who is primarily responsible for the initial drafting of the Master Formula Record in a pharmaceutical company?

#9. Arrange the following steps in correct order during MFR preparation:1. QA 2.Review Final Approval 3. Drafting by R&D 4.QA Numbering and Archival

#10. Read the following statements and choose the correct option: Statement I: MFR should be re-approved after any change in the manufacturing process. Statement II: MFR can be handwritten if typed documents are not available.

#11. Fill in the correct step order for MFR lifecycle management: Drafting → ______ → QA Review → ______ → Issuance → Archiving

#12. During a regulatory audit, the inspector asks for the MFR of a batch. You provide the Batch Manufacturing Record (BMR) instead. What issue arises?

#13. If a change is made to the raw material quantity in MFR, then:

#14. Fill in the missing section of the MFR template: Section No. Section Title 1 Product Name and Strength 2 Batch Size 3 _______________________ 4 Manufacturing Instructions 5 Packaging & Labeling Details

#15. Which of the following regulatory bodies is most likely to inspect and verify MFR compliance during audits?

#16. True or False: The MFR must contain instructions for in-process controls.

#17. Which of the following is the best documentation practice while preparing an MFR?

#18. You observe an MFR with no revision history table. What is the biggest risk of this omission? A. Duplication of batches

#19. Choose the correct order of steps during MFR creation: 1. QA Approval 2. Draft by R&D 3. Numbering and Versioning 4. Review by Production

#20. Which of the following does NOT complete a full MFR?

#21. One of the following is not essential for MFR compliance under cGMP. Choose which:

#22. In documentation terminology, MFRs are considered _____ documents, whereas Batch Manufacturing Records (BMRs) are executed documents.

#23. Which guideline mandates that each pharmaceutical product must have an MFR to ensure quality consistency?

#24. If a deviation occurs during the execution of a batch, but the MFR was followed exactly, what should be the first action?

#25. Which GMP principle is most directly reinforced by preparing and using a Master Formula Record?

#26. If a Batch Manufacturing Record (BMR) does not match the MFR, what could be the most likely root cause?

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