Regulatory Aspects of Impurities in Biological Products - IIR

Question 3
Is the impurity generally considered safe by the
industry and/or a qualified toxicologist familiar
with the area? Is the impurity within published
limits considering the dose and route of
administration?
Yes – No acceptance criteria is necessary,
provided that product quality or stability is not
compromised (Move to question 7)
No – move to Question 4