Operational Qualification

Operational Qualification

Operational Qualification (kurz OQ) ist ein Schritt aus den GMP-Regularien.
Der dokumentierte Nachweis, dass sich ein System oder Systemteil so verhält, wie zugesichert. In funktionalen Tests über alle Betriebsarten müssen die Betriebswerte innerhalb der spezifizierten Toleranzbereiche liegen.


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