Scale Up Post Approval Changes (SUPAC) MCQs With Answer

Scale Up Post Approval Changes (SUPAC) MCQs With Answer

This quiz collection is designed for M.Pharm students to deepen understanding of SUPAC principles relevant to product development and technology transfer. It covers regulatory classifications, documentation pathways, comparability assessment, control strategies, and when in vitro or in vivo studies are required after changes to formulation, process, equipment, site, or packaging. Questions emphasize the scientific rationale behind regulatory decisions, such as critical quality attributes, process validation, and QbD concepts that can reduce regulatory burden. Use these MCQs to test your applied knowledge for regulatory submissions, scale-up planning, and post-approval change management.

Q1. What is the primary focus of SUPAC guidance?

• Providing regulatory and scientific recommendations for scale-up and post-approval changes to ensure product quality and performance
• Establishing clinical trial design requirements for new drug approvals
• Guiding labeling and marketing claims for pharmaceutical products
• Specifying pricing and reimbursement strategies for marketed drugs

Correct Answer: Providing regulatory and scientific recommendations for scale-up and post-approval changes to ensure product quality and performance

Q2. Under typical SUPAC classification, which level of change usually requires a Prior Approval Supplement (PAS)?

• Level 1 — minor changes submitted in an annual report
• Level 2 — moderate changes notified by supplement with limited data
• Level 3 — major changes requiring a Prior Approval Supplement
• All levels are equivalent and none require PAS

Correct Answer: Level 3 — major changes requiring a Prior Approval Supplement

Q3. When is an in vivo bioequivalence study most likely required after a scale-up or post-approval change?

• When dissolution profile or rate/extent of absorption is likely to be altered by the change
• When only the printing on the secondary carton is modified
• Whenever the batch size increases by any amount
• When stability data at accelerated conditions are unavailable

Correct Answer: When dissolution profile or rate/extent of absorption is likely to be altered by the change

Q4. Which SUPAC guidance specifically addresses immediate-release solid oral dosage forms?

• SUPAC-IR (Immediate Release)
• SUPAC-SS (Semisolids)
• SUPAC-MR (Modified Release)
• SUPAC-Sterile

Correct Answer: SUPAC-IR (Immediate Release)

Q5. In the context of scale-up, what best describes “scale-up” activities?

• Increasing batch or equipment size while maintaining the validated critical process parameters and product quality
• Switching the active pharmaceutical ingredient to a new molecular entity
• Changing the marketing claims for an approved product
• Altering colorants solely for branding purposes

Correct Answer: Increasing batch or equipment size while maintaining the validated critical process parameters and product quality

Q6. A manufacturer wants to change the commercial manufacturing site for a sterile drug product. What is the usual regulatory expectation?

• The change typically requires a Prior Approval Supplement unless covered by an approved comparability protocol
• Site changes never require any regulatory notification
• Site changes can be implemented immediately and reported in the next annual report
• Only a change in the drug master file is required, not an application supplement

Correct Answer: The change typically requires a Prior Approval Supplement unless covered by an approved comparability protocol

Q7. What is the main purpose of a comparability protocol in the SUPAC framework?

• To define in advance the studies and acceptance criteria that will demonstrate that a post-approval change does not adversely affect product quality
• To request an extension of patent protection for a drug product
• To outline marketing strategies after scale-up
• To replace stability testing requirements entirely

Correct Answer: To define in advance the studies and acceptance criteria that will demonstrate that a post-approval change does not adversely affect product quality

Q8. For modified-release (MR) products, which outcome most often triggers the need for clinical pharmacokinetic studies after a manufacturing change?

• A change that alters the drug release mechanism or significantly modifies the in vitro release profile
• Any change in secondary packaging color
• Minor change in label font size
• Switching to a different non-functional overage

Correct Answer: A change that alters the drug release mechanism or significantly modifies the in vitro release profile

Q9. Which of the following is typically considered a critical quality attribute (CQA) relevant to SUPAC evaluations for oral solid dosage forms?

• Dissolution profile
• Color of the shipping pallet
• Size of the marketing team
• Name of the contract manufacturer

Correct Answer: Dissolution profile

Q10. Which statistical metric is commonly used to compare dissolution profiles for post-approval change assessments?

• f2 similarity factor
• Pearson correlation coefficient
• Kaplan–Meier estimator
• Odds ratio

Correct Answer: f2 similarity factor

Q11. How is “post-approval change” defined in regulatory terms?

• Any change to the approved drug substance, drug product, manufacturing process, facility, or controls after marketing approval
• A new indication submitted during initial approval
• A change in promotional materials only
• A manufacturing change that occurs prior to first marketing

Correct Answer: Any change to the approved drug substance, drug product, manufacturing process, facility, or controls after marketing approval

Q12. Which of the following is an appropriate regulatory expectation when changing a sterilization method for a terminally sterilized product?

• Conducting process validation (including worst-case cycles) and providing supporting data, often requiring a Prior Approval Supplement
• Implementing the change immediately without any supporting data
• Only changing the label to describe the new sterilization method
• Sending samples to a new contract lab without validation

Correct Answer: Conducting process validation (including worst-case cycles) and providing supporting data, often requiring a Prior Approval Supplement

Q13. When changing primary container-closure material, the main regulatory concern is:

• Impact on product stability, extractables/leachables, and container-closure integrity
• Color coordination with retail packaging
• Shipping costs related to package weight
• Font size on the immediate label

Correct Answer: Impact on product stability, extractables/leachables, and container-closure integrity

Q14. What are “scale-up batches” typically used for in technology transfer?

• To demonstrate process reproducibility and to generate data for process validation at commercial scale
• To test marketing messaging
• To create small promotional samples for physicians
• To replace stability studies entirely

Correct Answer: To demonstrate process reproducibility and to generate data for process validation at commercial scale

Q15. How does a Quality by Design (QbD) approach help with SUPAC-related changes?

• By establishing a design space and control strategy that can allow certain changes within that space without prior regulatory approval
• By eliminating the need for analytical testing after changes
• By ensuring every change requires a Prior Approval Supplement
• By focusing only on marketing outcomes rather than product quality

Correct Answer: By establishing a design space and control strategy that can allow certain changes within that space without prior regulatory approval

Q16. If an excipient vendor is changed but the excipient specification remains identical, what is typically required?

• Demonstration by analytical testing (e.g., identity, impurity profile, functional performance such as dissolution) that the change does not affect CQAs
• No testing or notification is ever required
• Immediate recall of all batches made with the previous vendor
• Only providing a new invoice to regulatory authorities

Correct Answer: Demonstration by analytical testing (e.g., identity, impurity profile, functional performance such as dissolution) that the change does not affect CQAs

Q17. What does a Prior Approval Supplement (PAS) require?

• Regulatory agency approval before implementing the proposed change
• Notification only in the next annual report
• Immediate implementation with no submission
• Only phone notification to the regional office

Correct Answer: Regulatory agency approval before implementing the proposed change

Q18. Which statement best describes a 30-day Notification Supplement (where applicable)?

• The sponsor notifies the agency and may implement the change 30 days after submission if the agency does not object
• The sponsor must wait one year before implementing any change
• It permits immediate implementation with no waiting period
• It is only used for labeling font-size changes

Correct Answer: The sponsor notifies the agency and may implement the change 30 days after submission if the agency does not object

Q19. When the synthetic route for the active pharmaceutical ingredient (API) is changed, the primary regulatory concern is:

• Potential changes in impurity profile and the need for re-evaluation of impurity safety and control strategies
• Only the color of the API powder
• Marketing exclusivity for the original route
• Whether the packaging supplier is the same

Correct Answer: Potential changes in impurity profile and the need for re-evaluation of impurity safety and control strategies

Q20. For BCS-based biowaiver considerations in SUPAC for immediate-release solid oral dosage forms, which classes are most commonly eligible?

• BCS Class I (high solubility, high permeability) and in some cases BCS Class III (high solubility, low permeability) under specific conditions
• BCS Class II exclusively
• Only BCS Class IV
• All BCS classes are equally eligible without conditions

Correct Answer: BCS Class I (high solubility, high permeability) and in some cases BCS Class III (high solubility, low permeability) under specific conditions

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