Post-approval changes to NDA or ANDA MCQs With Answer

Post-approval changes to NDA or ANDA are modifications made to an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) involving manufacturing, formulation, labeling, CMC, analytical methods, packaging, supplier or manufacturing site. Understanding regulatory pathways—such as prior-approval supplements (PAS), changes-being-effected (CBE), and annual reports—comparability protocols, SUPAC guidances, stability and bioequivalence requirements, and risk-based change control—is essential for B.Pharm students preparing for roles in quality assurance, regulatory affairs, and production. Key concepts include major versus minor changes, documentation, validation, regulatory timelines, and impact on drug quality, safety, and efficacy. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which regulatory submission is generally required before implementing a change that could significantly affect the safety or efficacy of a drug product?

• Annual report
• Prior-approval supplement (PAS)
• Changes-being-effected (CBE) notification
• Field alert report

Correct Answer: Prior-approval supplement (PAS)

Q2. Which document outlines planned post-approval changes and the data that will be provided to support them, and can be agreed with FDA in advance?

• Comparability protocol
• Drug master file (DMF)
• Stability protocol addendum
• Batch failure report

Correct Answer: Comparability protocol

Q3. In ANDA submissions, which of the following changes most likely requires demonstration of continued bioequivalence?

• Minor label text correction
• Change in tablet coating color with no functional effect
• Change in formulation excipient that affects dissolution
• Administrative site address change

Correct Answer: Change in formulation excipient that affects dissolution

Q4. What does SUPAC guidance primarily address?

• Labeling requirements for generics
• Scale-up and post-approval changes in manufacturing
• Clinical trial reporting
• Pricing and reimbursement strategies

Correct Answer: Scale-up and post-approval changes in manufacturing

Q5. Which reporting category allows a change to be implemented immediately upon submission to FDA?

• Prior-approval supplement (PAS)
• Annual report
• Changes-being-effected (CBE) for certain changes
• Field alert report

Correct Answer: Changes-being-effected (CBE) for certain changes

Q6. For a change in manufacturing site for the finished dosage form, which type of data is most commonly required?

• Only updated company address
• Process validation and stability data
• No data if it is within the same country
• New patent information

Correct Answer: Process validation and stability data

Q7. What is the primary purpose of a Postapproval Change Management Protocol (PACMP)?

• To delay regulatory submissions indefinitely
• To define agreed methods and acceptance criteria for future changes
• To replace the need for comparability studies
• To certify manufacturing employees

Correct Answer: To define agreed methods and acceptance criteria for future changes

Q8. When changing an API supplier, which document is critical to submit or reference?

• Biostatistics analysis plan
• Drug master file (DMF) or equivalent quality data
• Marketing authorization holder’s bank statement
• Clinical study protocol

Correct Answer: Drug master file (DMF) or equivalent quality data

Q9. Which of the following changes is most likely considered a minor change reportable in an annual report?

• Change in dose strength
• Major formulation reformulation
• Typographical correction in labeling
• Introduction of a new manufacturing site abroad

Correct Answer: Typographical correction in labeling

Q10. What type of stability data is typically required to support a change in primary packaging material?

• Short-term accelerated stability only
• Comparative stability under relevant storage conditions
• No stability data if dimensions are identical
• Only photostability data

Correct Answer: Comparative stability under relevant storage conditions

Q11. Which regulatory concept assesses whether a change may impact product quality, safety, or efficacy?

• Change control risk assessment
• Financial impact assessment
• Marketing feasibility study
• Patent infringement check

Correct Answer: Change control risk assessment

Q12. For a scale-up from pilot to commercial batch size, which SUPAC aspect is most relevant?

• Label artwork approval
• Scale-up effects on critical quality attributes and process parameters
• Marketing authorization transfer
• Clinical endpoint modification

Correct Answer: Scale-up effects on critical quality attributes and process parameters

Q13. If an applicant submits a CBE-30 supplement, what is implied by “30”?

• 30 days FDA review after submission before implementation
• 30 pages of documentation required
• 30 months of stability data mandatory
• 30 clinical subjects required

Correct Answer: 30 days FDA review after submission before implementation

Q14. Which department in a pharmaceutical company typically leads the evaluation and submission of post-approval changes?

• Regulatory affairs and quality assurance in collaboration
• Sales and marketing
• Human resources
• Finance

Correct Answer: Regulatory affairs and quality assurance in collaboration

Q15. What is a comparability study intended to demonstrate after a change?

• That the product name has been updated
• That the pre-change and post-change product are equivalent in quality, safety, and efficacy
• That manufacturing costs have decreased
• That the manufacturing facility is profitable

Correct Answer: That the pre-change and post-change product are equivalent in quality, safety, and efficacy

Q16. Which change would most likely trigger a requirement for new stability batches extending marketed shelf life?

• Updating the imprint code on tablet
• Changing storage conditions or container-closure system
• Correcting a typo on the package insert
• Adjusting sales territory

Correct Answer: Changing storage conditions or container-closure system

Q17. What is the main regulatory concern when altering an analytical method used for release testing?

• Impact on color of product labels
• Method suitability, validation, and comparability of results
• Change in sales forecasts
• Employee training hours

Correct Answer: Method suitability, validation, and comparability of results

Q18. For an ANDA, why is demonstrating sameness to the reference listed drug important after a post-approval change?

• To avoid patent disputes only
• To maintain bioequivalence and therapeutic equivalence
• To change the brand name
• To improve marketing claims

Correct Answer: To maintain bioequivalence and therapeutic equivalence

Q19. Which of the following is a potential outcome if a company implements a major manufacturing change without required approval?

• Improved regulatory standing automatically
• Regulatory action, product recall, or enforcement
• No consequences if product tastes the same
• Automatic extension of market exclusivity

Correct Answer: Regulatory action, product recall, or enforcement

Q20. What role does stability-indicating assay play in post-approval changes?

• It determines final product pricing
• It detects degradation and supports comparability after changes
• It replaces the need for process validation
• It is only required for biologics

Correct Answer: It detects degradation and supports comparability after changes

Q21. When updating labeling for safety information, which submission type is commonly used?

• Prior-approval supplement for trivial edits only
• Supplement (often CBE or PAS depending on change) to update labeling
• No submission is needed for any safety updates
• Only annual reports can contain safety updates

Correct Answer: Supplement (often CBE or PAS depending on change) to update labeling

Q22. Which is a key element in a regulatory justification for a post-approval change?

• Marketing budget
• Scientific data demonstrating no adverse impact on quality, safety, or efficacy
• Company logo redesign
• Number of employees at the site

Correct Answer: Scientific data demonstrating no adverse impact on quality, safety, or efficacy

Q23. Changing a non-pharmacologically active excipient that has no effect on release is usually classified as:

• A major change requiring PAS
• A likely minor change possibly reportable in an annual report
• Always requiring new clinical trials
• Illegal without a new application

Correct Answer: A likely minor change possibly reportable in an annual report

Q24. Which regulatory format is commonly used today to submit post-approval change documents electronically?

• Email only
• eCTD (electronic Common Technical Document)
• Paper forms exclusively
• Fax transmission

Correct Answer: eCTD (electronic Common Technical Document)

Q25. Which study type may be needed when a change affects drug release characteristics?

• Bioequivalence or in vitro dissolution comparative study
• Market analysis study
• Employee satisfaction survey
• Packaging color preference study

Correct Answer: Bioequivalence or in vitro dissolution comparative study

Q26. Who is ultimately responsible for ensuring post-approval changes comply with regulatory requirements?

• The regulatory authority only
• The marketing agency contracted by the company
• The marketing authorization holder / applicant
• The sales representative

Correct Answer: The marketing authorization holder / applicant

Q27. What is an appropriate first step when a manufacturing deviation necessitates a process change?

• Implement the change immediately without documentation
• Perform a root cause analysis and change control risk assessment
• Notify customers before assessing impact
• Increase production to compensate

Correct Answer: Perform a root cause analysis and change control risk assessment

Q28. Why are stability bridging studies important after a change in excipient supplier?

• They are only important for sterile products
• They demonstrate that new supplier material does not alter shelf-life or quality
• They replace the need for analytical method validation
• They are used to change dosage strength

Correct Answer: They demonstrate that new supplier material does not alter shelf-life or quality

Q29. Which of the following best describes “major” post-approval changes?

• Changes unlikely to affect quality, safety, or efficacy
• Changes with a substantial potential to adversely affect quality, safety, or efficacy
• Only administrative updates with no data required
• Changes limited to artwork color

Correct Answer: Changes with a substantial potential to adversely affect quality, safety, or efficacy

Q30. What is a practical benefit of establishing robust change control and documentation systems in a pharmaceutical company?

• They eliminate the need for regulatory submissions
• They ensure consistent product quality, regulatory compliance, and faster approvals
• They increase the number of product recalls
• They are only useful for marketing purposes

Correct Answer: They ensure consistent product quality, regulatory compliance, and faster approvals

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