Privatsphäre-Einstellungen

Zertifizierung durch eine sachkundige Person und Chargenfreigabe mit speziellem Fokus auf biologische Produkte

Dr. Ines Janssen

Korrespondenz: Ines Janssen, Ph.D., Baxter AG, Industriestr. 67, 1220 Wien (Österreich), e-mail: ines-janssen@baxter.com

Certification by a Qualified Person and Batch Release with a Special Focus on Batch Release of Biological Products

The certification by a Qualified Person (QP) on batch release requires well established Quality Systems and several documents for each single batch so that the QP is able to ensure all the items mentioned as routine duty of the QP in Annex 16, article 8.1a-h. Specific Quality Systems and special batch specific documentations are linked with these routine duties of the QP.
Batch release of biological products requires in addition an Official Control Authority Batch Release. The requirements in the EU and in the US are described. The possibility of an exemption from the lot to lot batch release by CBER is discussed.

Key words Annex 16 • Behördliche Chargenfreigabe • Behördliche Kontroll-Labors • Biologische Produkte • Chargenfreigabe • Sachkundigen Person • Zertifizierung