BioPharm International Supplements, February 2008 - BioPharm International

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BioPharm International Supplements, February 2008
Articles
Analytical Method Maintenance
By Stephan Krause, PhD
Several steps can be taken to maintain test method suitability after the formal completion of the analytical method validation studies,
Strategies for Validation Extensions
By Stephan Krause, PhD
It is essential to understand the critical elements of validation extensions to ensure accurate process or product quality measurements.
Formal Method Validation
By Stephan Krause, PhD
The development and optimization process can improve a method, but validation does not. Validation is the final proof that regulations and expectations are met.
Analytical Method Development and Optimization
By Stephan Krause, PhD
Validation of analytical methods can be more easily accomplished by breaking the task down into a series of planned steps.

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