Classification | Description and subclassification |
---|---|
Original | • Formulation detected fully matches the one declared on the label/ accurately labeled (qualitative) • Levels of active pharmaceutical ingredients (AI) detected are between the defined range of the declared formulation defined by the individual studya (quantitative) |
Substandard | • Formulation detected fully matches the one declared/ accurately labeled (qualitative) • Levels of AI detected are not between the acceptable range defined for original productsa (quantitative) • Subclassification (quantitative): - Over-concentrated: AI detected above defined range - Under-concentrated: AI detected below defined range |
Counterfeitb | • Formulation detected does not match the label/ not accurately labeled (qualitative) • Subclassification (qualitative): - Inert: no AI present - Substituted: different AI than labeled present - Adulterated: not all or more AI than the labeled AI present |