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Therefore, further discussions and a future guideline revision of requirements and acceptance limits should be considered.
FDA and EU GMPs do not set acceptance limits; it is up to each company to establish and justify acceptance limits.
There are sources of variability in PT/EQA results not found in patient results that may cause the acceptance limits to be larger than what is needed on the basis of clinical requirements.
Both the enteric coated multiparticulate dosage forms complies largely with the gastro-resistance specifications of acceptance limits. The coating efficiency is resulted higher for the pellets, even if their surface area (mathematically calculated) is about three times more extensive than that of minitablets.
Disposal companies are requested from the framework agreement on the tender offer, the acceptance limits of which are above the pollutant concentrations of the hazardous mineral wastes and which ensure the necessary assumption quantities.

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