Eudralex Volume 3 NOTE FOR GUIDANCE ON Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Title:
Eudralex Volume 3 NOTE FOR GUIDANCE ON Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

https://www.gmp-compliance.org/files/guidemgr/ich-q-5-r2-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-animal-origin_en.pdf

Origin/Publisher:

European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/

Document Type:
Note for Guidance
Content:
This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin (i.e. mammalian, avian, insect) and outlines data that should be submitted in the marketing application/registration package. For the purposes of this document the term virus excludes nonconventional transmissible agents like those associated with Bovine Spongiform Encephalopathy (BSE) and scrapie. Applicants are encouraged to discuss issues associated with BSE with the regulatory authorities.

Go back