The acceptance criteria are rigorous and designed to catch outliers while accounting for manufacturing variability.
The safety and efficacy of a medicinal product depend heavily on the consistency of the dose delivered to the patient. If a tablet contains significantly more or less Active Pharmaceutical Ingredient (API) than indicated, it could lead to therapeutic failure or toxicity. is the standard procedure used across Europe (and harmonized globally) to verify this consistency. It replaces older methods (such as the previous "Weight Variation" test) with a more statistically rigorous approach. gdp ep 406
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