Drug Master File (DMF) – types and structure MCQs With Answer

Drug Master File (DMF) – types and structure is a key regulatory dossier that protects confidential manufacturing, quality and control details of drug substances, excipients, packaging and facilities. B.Pharm students should understand DMF purpose, common DMF types (Type I facilities, Type II drug substance/intermediate, Type III packaging, Type IV excipients, Type V reference information), and the typical structure: administrative data, manufacturing process, specifications, analytical methods, validation and stability. Familiarity with CTD mapping (Module 3), Letters of Authorization, confidentiality, and updating procedures is essential for regulatory affairs and quality roles. Clear knowledge of DMF use in NDAs/ANDAs enhances compliance and product approval success. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of a Drug Master File (DMF)?

• To replace the drug application for marketing approval
• To provide confidential detailed manufacturing and control information to regulators
• To list all adverse events for a drug
• To publish pricing and commercial strategies

Correct Answer: To provide confidential detailed manufacturing and control information to regulators

Q2. Which DMF type is primarily used for active pharmaceutical ingredients (APIs) and drug substances?

• Type I
• Type II
• Type III
• Type V

Correct Answer: Type II

Q3. Which DMF type typically covers excipients, colorants and flavoring agents?

• Type III
• Type IV
• Type I
• Type V

Correct Answer: Type IV

Q4. In DMF structure, which section most directly contains manufacturing process flow and controls?

• Administrative correspondence
• Specifications and analytical procedures
• Manufacturing process and control section
• Stability summary

Correct Answer: Manufacturing process and control section

Q5. Which DMF type is associated with packaging materials?

• Type II
• Type IV
• Type III
• Type I

Correct Answer: Type III

Q6. What is a Letter of Authorization (LOA) in the context of a DMF?

• A marketing authorization for a drug product
• A legal transfer of DMF ownership
• A written consent allowing an applicant to reference the DMF during regulatory review
• An annual fee payment receipt

Correct Answer: A written consent allowing an applicant to reference the DMF during regulatory review

Q7. Which CTD module aligns most closely with the quality information usually provided in a DMF?

• Module 1
• Module 2
• Module 3
• Module 5

Correct Answer: Module 3

Q8. What type of information is typically found in the administrative section of a DMF?

• Analytical method validation data
• Stability study raw data
• DMF holder contact details, table of contents, and letter of authorization templates
• Batch manufacturing records in full

Correct Answer: DMF holder contact details, table of contents, and letter of authorization templates

Q9. Why is confidentiality of DMF content important?

• To prevent regulators from sharing documents
• To protect proprietary manufacturing know-how and trade secrets
• To allow public access to raw data
• To avoid filing fees

Correct Answer: To protect proprietary manufacturing know-how and trade secrets

Q10. Which of the following is NOT typically a major component of the quality section in a DMF?

• Specifications and acceptance criteria
• Analytical procedures and validation
• Marketing strategy and competitor analysis
• Stability data and storage conditions

Correct Answer: Marketing strategy and competitor analysis

Q11. When an applicant references a DMF in an NDA or ANDA, what must the applicant provide to the regulator?

• An independent duplicate of the DMF
• A Letter of Authorization or equivalent permission
• Full access to the DMF holder’s facility
• An additional Type V DMF

Correct Answer: A Letter of Authorization or equivalent permission

Q12. Which DMF type is often used for facility, equipment and operating procedure details?

• Type I
• Type II
• Type IV
• Type V

Correct Answer: Type I

Q13. What is the typical role of stability data within a DMF?

• To justify labeling claims unrelated to formulation
• To establish storage conditions, shelf life and stability-indicating methods
• To provide clinical efficacy information
• To replace the need for specifications

Correct Answer: To establish storage conditions, shelf life and stability-indicating methods

Q14. How should analytical methods included in a DMF be documented?

• Only by naming the instrument used
• With complete method description, validation data, and acceptance criteria
• As unpublished internal notes without validation
• Only as references to published literature

Correct Answer: With complete method description, validation data, and acceptance criteria

Q15. Which statement best describes a Type V DMF?

• A DMF exclusively for clinical trial designs
• A miscellaneous category for FDA-accepted reference information not covered by other types
• A DMF for final marketed labels
• A DMF for foreign inspection reports

Correct Answer: A miscellaneous category for FDA-accepted reference information not covered by other types

Q16. What should a DMF holder do when critical manufacturing information changes?

• Wait for the next product approval to inform regulators
• Submit an amendment or update the DMF promptly to maintain accuracy
• Only notify the final product manufacturer
• Delete the old DMF and create a new one without notice

Correct Answer: Submit an amendment or update the DMF promptly to maintain accuracy

Q17. Which of the following is a key difference between a DMF and an NDA/ANDA?

• DMF contains confidential manufacturing details while NDA/ANDA contains safety and efficacy data for marketing approval
• NDA/ANDA is confidential but DMF is public
• DMF includes clinical trial reports while NDA/ANDA does not
• There is no difference; they are interchangeable

Correct Answer: DMF contains confidential manufacturing details while NDA/ANDA contains safety and efficacy data for marketing approval

Q18. In the CTD-aligned DMF, where are certificates of analysis and batch data usually placed?

• Module 1
• Module 2 summaries
• Module 3 appendices or supporting documents
• Module 5

Correct Answer: Module 3 appendices or supporting documents

Q19. What role do impurity profiles and related substances play in a DMF?

• They are only relevant for clinical pharmacology
• They define safety-critical quality attributes and acceptance limits
• They are not required if the API is pure
• They are disclosed only to the public

Correct Answer: They define safety-critical quality attributes and acceptance limits

Q20. Which document often accompanies a DMF when an applicant references it in a drug submission?

• A public summary of clinical trials
• An authorization letter or statement of reliance
• A manufacturing license for the applicant
• A commercial supply agreement

Correct Answer: An authorization letter or statement of reliance

Q21. For regulatory review, why is method validation data important in a DMF?

• It demonstrates that analytical methods are suitable for intended use and reliable
• It lists the names of analysts who performed tests
• It replaces the need for specifications
• It is only used for marketing materials

Correct Answer: It demonstrates that analytical methods are suitable for intended use and reliable

Q22. What is the advantage for manufacturers to submit a DMF rather than disclose details directly in an NDA?

• DMF is always faster to review than NDA
• DMF protects proprietary details through confidential filing while still allowing applicants to reference the information
• DMF eliminates the need for quality testing
• DMF automatically grants marketing approval

Correct Answer: DMF protects proprietary details through confidential filing while still allowing applicants to reference the information

Q23. Which piece of information is least likely to be included in a DMF?

• Process validation and in-process controls
• Complete clinical efficacy data
• Specifications for raw materials
• Container closure and packaging details

Correct Answer: Complete clinical efficacy data

Q24. How does the European ASMF (Active Substance Master File) relate to the DMF concept?

• ASMF is unrelated and only covers food additives
• ASMF is a regional equivalent focusing on active substance confidentiality and quality, similar to DMF
• ASMF replaces the need for any NDA
• ASMF is only used for veterinary products

Correct Answer: ASMF is a regional equivalent focusing on active substance confidentiality and quality, similar to DMF

Q25. What is an appropriate format for organizing a DMF intended for global regulatory review?

• A random collection of PDFs without indexing
• CTD-aligned organization with clear modules, table of contents and indexed appendices
• Only physical paper copies with no electronic submission
• Marketing brochures followed by test reports

Correct Answer: CTD-aligned organization with clear modules, table of contents and indexed appendices

Q26. If a DMF holder wants to permit multiple applicants to reference the DMF, what is recommended?

• Provide a generic LOA that names all future applicants
• Issue separate Letters of Authorization for each applicant or include appropriate wording to allow reliance
• Make the DMF publicly available online
• Transfer the DMF ownership to the regulator

Correct Answer: Issue separate Letters of Authorization for each applicant or include appropriate wording to allow reliance

Q27. In a DMF, what is the significance of including batch analyzers and certificates of analysis?

• They are only ceremonial and not reviewed
• They demonstrate consistent control of product quality and lot-to-lot reproducibility
• They are used to market the product to consumers
• They replace the need for process descriptions

Correct Answer: They demonstrate consistent control of product quality and lot-to-lot reproducibility

Q28. Who is typically responsible for maintaining a DMF and ensuring updates are submitted?

• The final product distributor by default
• The DMF holder or owner (manufacturer/supplier)
• The regulatory authority
• Each clinical investigator

Correct Answer: The DMF holder or owner (manufacturer/supplier)

Q29. Which of the following change types would most likely require a DMF amendment and possible applicant notification?

• Minor formatting changes to the DMF PDF
• Changes in critical process parameters or supplier of the API
• Changing the DMF holder’s logo
• Updating non-critical contact information only

Correct Answer: Changes in critical process parameters or supplier of the API

Q30. For B.Pharm students studying regulatory affairs, which DMF-related skill is most valuable?

• Designing marketing campaigns for generics
• Understanding DMF content requirements, CTD mapping, LOAs and change control for quality compliance
• Learning only clinical trial statistics
• Focusing solely on sales projections

Correct Answer: Understanding DMF content requirements, CTD mapping, LOAs and change control for quality compliance

Download