Eudralex Volume 3 Requirements for quality documentation concerning biological investigational medicinal products in clinical trials

Title:
Eudralex Volume 3 Requirements for quality documentation concerning biological investigational medicinal products in clinical trials

https://www.gmp-compliance.org/files/guidemgr/guideline-requirements-quality-documentation-concerning-biological-investigational-medicinal_en-0.pdf

Origin/Publisher:

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

Document Type:
Guideline
Content:
This guideline outlines the requirements for the data to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Products (IMP) containing biological / biotechnology derived substances.

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