Definitionen und Anforderungen an Referenzstandards in der Arzneimittelprüfung
Markus Veit1 und Stefan Wissel2
1 i.DRAS GmbH, Planegg
The measurement and analytical procedures applied for testing medicinal products are frequently calibrated and validated using reference substances (primary and secondary reference standards). Since the accuracy of the analytical procedures is exclusively determined using the reference standards employed for calibration, the quality of these reference standards plays an extraordinarily important role. The following overview summarises the regulatory framework and definitions relevant for the use of reference standards in GMP environment.
pharmind 2007, Nr. 12, Seite 1475