Which defect in tablets is a critical quality attribute?

The correct answer is D. All of the above. All three options represent critical quality attributes for tablets because each directly impacts safety, efficacy, or patient acceptability - the three pillars of pharmaceutical quality. Color variation (A) can signal non-uniform drug distribution, degradation, or…

Quality Systems

Question

Options

AColor variation
BChipping
CWeight variation
DAll of the above

How the community answered

(57 responses)

A
5% (3)
B
12% (7)
C
2% (1)
D
81% (46)

Explanation

All three options represent critical quality attributes for tablets because each directly impacts safety, efficacy, or patient acceptability - the three pillars of pharmaceutical quality.

Color variation (A) can signal non-uniform drug distribution, degradation, or contamination, making it a formulation integrity concern, not merely cosmetic.
Chipping (B) compromises dose accuracy (broken tablets deliver less drug), can cause aspiration risk, and indicates inadequate physical integrity of the dosage form.
Weight variation (C) directly reflects dose uniformity - excessive variation means patients may receive sub-therapeutic or toxic amounts.

Memory tip: Think "SPA" - Safety, Patient acceptability, and Accuracy (dose). Any defect that threatens even one of these three is a critical quality attribute, and all three options do exactly that.

Topics

#Tablet defects#Critical quality attributes#GMP quality standards#Manufacturing specifications

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