Articles by Stephan Krause, PhD - BioPharm International

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Articles by Stephan Krause, PhD

QbD for Analytical Methods

A gradual approach may get us QbD-ready while providing immediate benefits.
Feb 1, 2009

QbD for QA? Try a two-step approach

Validation Failure is Not an Option. Should it be?

Under the current regulations, there is no system that allows a firm to openly deal with validation failures
Jun 1, 2008

The industry needs to open up to validation failures.

Formal Method Validation

The development and optimization process can improve a method, but validation does not. Validation is the final proof that regulations and expectations are met.
Feb 2, 2008

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 Maintenance

Several steps can be taken to maintain test method suitability after the formal completion of the analytical method validation studies
Feb 2, 2008

Several steps can be taken to maintain test method suitability after the formal completion of the analytical method validation studies,

Analytical Method Development and Optimization

Validation of analytical methods can be more easily accomplished by breaking the task down into a series of planned steps.
Feb 2, 2008

Validation of analytical methods can be more easily accomplished by breaking the task down into a series of planned steps.

Strategies for Validation Extensions

It is essential to understand the critical elements of validation extensions to ensure accurate process or product quality measurements.
Feb 2, 2008

It is essential to understand the critical elements of validation extensions to ensure accurate process or product quality measurements.

A Guide for Testing Biopharmaceuticals Part 2: Acceptance criteria and analytical method maintenance

Oct 1, 2006

The first part of this article, published in the September 2006 issue, discussed general strategies for validation extensions to other test method components, laboratories and even different test methods.1This second part provides practical tips on how to maintain test method suitability long after the formal completion of analytical method validation (AMV) studies.

A Guide for Testing Biopharmaceuticals Part 1: General Strategies for Validation Extensions

Sep 1, 2006

Good risk management tools dictate how much assay performance characteristics can deviate from ideal.

How to Maintain Suitable Analytical Test Methods: Tools for Ensuring a Validation Continuum

Oct 1, 2005

Many industry professionals know that analytical testing for biopharmaceuticals for all raw materials, production in-process stages, and final containers must be validated, and they generally understand how this can be achieved. Many of us even understand the basic concepts of laboratory compliance and production process quality. However, how exactly are analytical test method performance and process robustness related and how do they depend on each other? Furthermore, how do we monitor and maintain the accuracy and reliability of analytical methods long after validation completion to ensure the suitability of these methods for measuring process quality?

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