Qualification of a Chromotographic Column
Pharmaceutical Technology Europe
In this article, five industry experts share their insights to ensure that your column qualification protocols can survive the increased scrutiny of FDA inspectors.
The US Food and Drug Administration (FDA) has become more knowledgeable regarding process chromatography - and more demanding concerning column qualification. In this article, five industry experts share their insights on how to qualify a chromatographic column. Their advice: write unambiguous standard operating procedures (SOPs); focus on the reproducibility of column packing; choose appropriate metrics; and analyse your testing procedures to reduce the chance of erroneous results.
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Clinical Supply Planning in Europe - Balancing Cost, Flexibility and Time
December 19th 2024The packaging and distribution of clinical supplies is a fundamental piece to the overall success of a clinical trial, and advance preparation can help establish a more efficient supply chain. Selecting the best geographical location for those activities, however, depends on the clinical trial protocol, business decisions, and even the investigational medicinal product (IMP) being studied.
