BioPharm International-03-01-2014

BioPharm International

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

March 01, 2014

Peer-Reviewed Research

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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.

Single-Use Technology for Syringe Filling

March 01, 2014

Special Section

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A novel approach to sterile drug product manufacturing that uses a single-use assembly in a multi-product final filling suite with isolator technology offers benefits of efficiency and flexibility.

BioPharm International, March 2014 Issue (PDF)

March 01, 2014

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Click the title above to open the BioPharm International March 2014 issue in an interactive PDF format.