Adventitious agent safety of urine-derived medicinal products - Scientific guideline

This guideline considers various aspects of virus safety of urine-derived medicinal products. Incorporation of effective steps for virus inactivation/removal is considered a key measure towards virus safety and guidance on validation of process steps for virus inactivation/removal is provided.

Human urine is used to prepare several products indicated in the field of endocrinology, such as human chorionic gonadotropin (hCG), human menopausal gonadotropin or menotropin (HMG) and follicle-stimulating hormone (FSH) and urokinase products used for thrombolysis. This document addresses specific aspects which should be taken into consideration in the evaluation of viral and TSE safety of medicinal products derived from human urine.