Privatsphäre-Einstellungen

Delegierung und Differenzierung der Verantwortlichkeiten einer Qualified Person

Ines Janssen

Baxter AG, Wien (Österreich)

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

Delegating and Differentiating the Responsibility of a Qualified Person

Often a batch has different stages of production or testing conducted at different locations or by different manufacturers. An intermediate or bulk production batch may be divided into more than one finished product batch. In these cases delegating of the responsibility of a Qualified Person (QP) is necessarymostly based on Quality Agreements between the different sites / QPs. Annex 16 to the EUGMP-Guide defines the responsibilities of a QP in such cases in detail.
Special requirements have to be followed if products are imported from third countries outside the EC/EEA. Is a mutual recognition agreement (MRA) in place the import from that country is much simplified.

Key words Annex 16 • Chargenfreigabe • Delegierung der Verantwortung • Gegenseitige Anerkennung • Herstellung, unterschiedliche Orte • Sachkundige Person