Articles by Mark Mitchell - BioPharm International

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Articles by Mark Mitchell

Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle

The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
Mar 1, 2014

This series presents a practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three stages of the process validation lifecycle. In Parts I and II, risk analysis and process characterization studies were used to assign criticality risk levels to critical quality attributes and critical process parameters, and the concept of a continuum of criticality was established. In Part III, the author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.

Determining Criticality—Process Parameters and Quality Attributes Part II; Design of Experiments and Data-Driven Criticality

A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
Jan 1, 2014

Criticality is used as a risk-based tool to drive control strategies.

Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum

A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
Dec 1, 2013

Criticality is used as a risk-based tool to drive control strategies.

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