Utilizing Capillary Electrophoresis in a Quality Control Environment
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Presented by: Chantal Felten, Ph.D., Alpine Analytical Academy
Original Date: March 30, 2010 at 10 am PDT
Abstract:
A decade ago, capillary electrophoresis was considered a novelty; today, it is a common sight in Quality Control, providing high-resolution methods, online detection and automation. These advantages far outweigh the growing pains of introducing a new technology into a QC environment. One wonders why everyone has not yet converted their conventional gel methods to capillary electrophoresis.
Complete integration of capillary electrophoresis into the QC environment continues to be burdened by these common myths.
Myth:
CE is not applicable to QC |
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Fact:
CE is no more difficult than other technologies but the typical QC analyst has limited capillary electrophoresis experience and requires proper training. |
Myth:
CE cannot be validated |
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Fact:
CE methods have been successfully validated and implemented into QC by many pharmaceutical companies. |
Myth:
Regulatory agencies do not accept CE methods |
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Fact:
The FDA as well as the EP is starting to request CE methods for replacement of conventional slab-gel methods. |
The webinar focuses on discussing some of the main applications of CE on Quality Control systems. Emphasis is given to the GMP elements such as instrument qualification, validation, transfer and training. This webinar is designed to give a broad overview on the capabilities of CE on a Quality Control system.
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