Introduction: SUPAC guidelines provide practical, regulatory guidance on scale-up and post-approval changes in pharmaceutical manufacturing. For B.Pharm students, understanding SUPAC is essential to manage change control, maintain product quality, and meet regulatory expectations. Key topics include SUPAC-IR, SUPAC-MR and SUPAC-SS, comparability studies, dissolution testing, similarity factor (f2), process validation, stability assessment, and bioequivalence considerations. These guidelines help determine when in vitro tests suffice or when in vivo studies and regulatory supplements (CBE vs PAS) are required. Mastery of SUPAC concepts supports robust documentation, risk-based decision making, and faster regulatory pathways. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of the SUPAC guidance?
- To provide a framework for scale-up and post-approval changes that ensures continued product quality
- To set pricing and reimbursement policies for pharmaceuticals
- To outline clinical trial design for new molecular entities
- To regulate pharmaceutical advertising and promotion
Correct Answer: To provide a framework for scale-up and post-approval changes that ensures continued product quality
Q2. SUPAC guidance is primarily intended to address which phase of a drug product lifecycle?
- Post-approval manufacturing changes
- Preclinical toxicology testing
- Initial clinical development
- Product marketing and sales
Correct Answer: Post-approval manufacturing changes
Q3. SUPAC-IR specifically covers which dosage form?
- Immediate-release solid oral dosage forms
- Modified-release oral dosage forms
- Nonsterile semisolid dosage forms
- Sterile injectable products
Correct Answer: Immediate-release solid oral dosage forms
Q4. Which SUPAC guidance addresses modified-release products?
- SUPAC-MR (modified release)
- SUPAC-IR (immediate release)
- SUPAC-SS (semisolid)
- SUPAC-ST (sterile)
Correct Answer: SUPAC-MR (modified release)
Q5. SUPAC-SS is focused on which product category?
- Nonsterile semisolid dosage forms
- Sterile semisolid injectables
- Solid oral chewable tablets
- Parenteral solutions
Correct Answer: Nonsterile semisolid dosage forms
Q6. Which critical quality attribute is most commonly evaluated under SUPAC for immediate-release tablets?
- Dissolution profile
- Tablet color
- Package artwork
- Sales forecast
Correct Answer: Dissolution profile
Q7. SUPAC classifies post-approval changes based on which criterion?
- Potential to impact product quality and performance
- Cost of implementing the change
- Historical sales volume of the product
- Marketing strategy complexity
Correct Answer: Potential to impact product quality and performance
Q8. Which analytical comparison is commonly used to demonstrate dissolution equivalence for IR products after a change?
- Similarity factor f2
- Minimum inhibitory concentration (MIC)
- Log P value
- Thermal decomposition point
Correct Answer: Similarity factor f2
Q9. A similarity factor f2 value that generally indicates comparable dissolution profiles is:
- 50–100
- 0–20
- 20–40
- 10–30
Correct Answer: 50–100
Q10. If a manufacturing change is likely to alter bioavailability significantly, regulators typically require which study?
- In vivo bioequivalence study
- Marketing focus group
- Accelerated stability alone
- Packaging performance test only
Correct Answer: In vivo bioequivalence study
Q11. SUPAC allows waiving in vivo bioequivalence studies when which condition is met?
- Robust in vitro dissolution and comparability data demonstrate equivalence
- The product is sold in more than ten countries
- The formulation has a long market history regardless of data
- The company requests a waiver without data
Correct Answer: Robust in vitro dissolution and comparability data demonstrate equivalence
Q12. Which regulatory submission is generally required for major post-approval changes that significantly affect product quality?
- Prior Approval Supplement (PAS)
- Annual Report
- Field Alert Report
- Financial Disclosure
Correct Answer: Prior Approval Supplement (PAS)
Q13. Which submission type may allow a manufacturer to implement certain changes before regulatory approval?
- Changes Being Effected (CBE) supplement
- Prior Approval Supplement (PAS)
- Investigational New Drug (IND) application
- New Drug Application (NDA)
Correct Answer: Changes Being Effected (CBE) supplement
Q14. Essential data elements in a SUPAC comparability package commonly include:
- Batch manufacturing records, comparative dissolution, and stability data
- Only marketing materials and pricing
- Only the clinical study protocol
- Only supplier financial statements
Correct Answer: Batch manufacturing records, comparative dissolution, and stability data
Q15. SUPAC guidance supports the application of which modern pharmaceutical quality approach?
- Quality by Design (QbD)
- Just-in-Time Marketing
- Randomized Pricing Strategy
- Ad hoc process control
Correct Answer: Quality by Design (QbD)
Q16. For modified-release products, additional SUPAC-relevant evaluations often include:
- Multi-pH dissolution testing and IVIVC considerations
- Only color matching of tablets
- Marketing authorization in each state
- Retail shelving tests
Correct Answer: Multi-pH dissolution testing and IVIVC considerations
Q17. When compression force is changed during scale-up, which product attributes should be evaluated?
- Hardness, disintegration and dissolution
- Only the tablet imprint
- Only the bulk density of packaging
- Only the color of the tablet
Correct Answer: Hardness, disintegration and dissolution
Q18. A change in an excipient that alters drug release rate typically requires:
- In vitro comparability and possibly in vivo studies
- No documentation if cost is low
- Only a marketing update
- Removal of the product from market
Correct Answer: In vitro comparability and possibly in vivo studies
Q19. Changing primary packaging to a material with different moisture barrier properties requires:
- Additional stability testing to assess impact on product quality
- Only a change in label font
- Only a cost analysis
- Immediate discontinuation of product
Correct Answer: Additional stability testing to assess impact on product quality
Q20. Which of the following is least likely to be considered a critical quality attribute (CQA)?
- Office layout of the manufacturing unit
- Drug potency (assay)
- Dissolution rate
- Impurity profile
Correct Answer: Office layout of the manufacturing unit
Q21. In SUPAC comparability packages, “worst-case” batches are chosen to:
- Challenge product performance and reveal potential differences
- Show only the best-performing batches
- Represent the most expensive production runs
- Match the batches used in unrelated products
Correct Answer: Challenge product performance and reveal potential differences
Q22. Which regulatory agency issued the SUPAC guidances commonly used in pharmaceutical industry?
- U.S. Food and Drug Administration (FDA)
- World Health Organization (WHO)
- European Central Bank (ECB)
- International Monetary Fund (IMF)
Correct Answer: U.S. Food and Drug Administration (FDA)
Q23. One major benefit of following SUPAC guidance is reducing the need for:
- Unnecessary clinical or in vivo studies when in vitro data suffice
- Investment in manufacturing equipment
- Quality control testing
- Regulatory submissions
Correct Answer: Unnecessary clinical or in vivo studies when in vitro data suffice
Q24. When an analytical method is changed materially after a CMC change, SUPAC expectations include:
- Demonstrating method suitability and comparability of results
- Removing the method from the file without testing
- Only updating the method title
- Submitting marketing materials
Correct Answer: Demonstrating method suitability and comparability of results
Q25. For narrow therapeutic index drugs, post-change assessments are more likely to require:
- In vivo bioequivalence or more stringent comparability studies
- Only a color stability test
- Only an update to the label design
- Elimination of dissolution testing
Correct Answer: In vivo bioequivalence or more stringent comparability studies
Q26. SUPAC change control documentation should include which elements?
- Risk assessment, comparability protocols, and supporting batch data
- Only the marketing budget
- Only supplier contact names
- Only the CEO approval signature
Correct Answer: Risk assessment, comparability protocols, and supporting batch data
Q27. Which of the following is NOT a typical post-approval change covered by SUPAC?
- Adding a new therapeutic indication to the label
- Altering manufacturing site or equipment
- Changing excipient grade or supplier
- Scaling up batch size
Correct Answer: Adding a new therapeutic indication to the label
Q28. Why is API particle size an important consideration during scale-up under SUPAC?
- It influences dissolution rate and potentially bioavailability
- It determines the color of the final tablet
- It has no effect on product quality
- It only affects shipping costs
Correct Answer: It influences dissolution rate and potentially bioavailability
Q29. An in vitro tool that can support bioequivalence for some modified-release products is:
- In vitro–in vivo correlation (IVIVC)
- Marketing analytics
- Sales representative feedback
- Tablet embossing pattern
Correct Answer: In vitro–in vivo correlation (IVIVC)
Q30. The primary audience for SUPAC guidance includes:
- Manufacturing, quality and regulatory professionals in the pharmaceutical industry
- Retail pharmacists only
- Medical insurance companies
- General consumers
Correct Answer: Manufacturing, quality and regulatory professionals in the pharmaceutical industry
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com