Which of the following is a typical example of a critical quality attribute (CQA) in pharmaceutical product development?

• A. Color of the packaging
• B. Potency
• C. Brand name
• D. Advertising slogans

Answer: (B)

Potency is a typical example of a critical quality attribute because it directly reflects the amount or activity of the active pharmaceutical ingredient delivered in each dose, which determines the therapeutic effect. CQAs are properties that must stay within defined limits to ensure safety and efficacy; if potency deviates, patients may receive too little drug (subtherapeutic effect) or too much (increased risk of adverse effects), undermining the product’s intended performance. Other options—color of packaging, brand name, and advertising slogans—do not measure the product’s quality, safety, or efficacy and are considered marketing or presentation aspects rather than CQAs.