Referenzstandards in der Arzneimittelprüfung Anforderungen bei Beschaffung, Bereitstellung und Lagerung 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 GMP-relevant aspects concerning the establishment and use of those standards. |
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pharmind 2008, Nr. 1, Seite 135
