January / February 2015

January / February 2015 Cover


Risk Assessment: Issues and Challenges

by Joe Brady, PhD
This article presents an opinion and a perspective on the practical application of risk assessment, on how to adopt a scientific approach to the risk management process, and also informally dispenses some simple and pragmatic advice that may enhance a risk exercise.

CMC Considerations when a Drug Development Project is Assigned Breakthrough Therapy Status

by Earl S. Dye, PhD, John Groskoph, Brian Kelley, George Millili,PhD, Moheb Nasr, PhD, Christopher J. Potter PhD, Eric Thostesen, and Hans Vermeersch
This article discusses the impact on Chemistry, Manufacturing and Control (CMC) part of a development project when a project is assigned Breakthrough Therapy (BT) status as given in Food and Drug Administration Safety and Innovation Act (FDASIA) and FDA Guidance on Expedited Programs for Serious Conditions.

Science-Based Quality Risk Management

This article describes Quality Risk Management as it relates to ISPE Guidance Documents and was developed collaboratively by the leaders of the Guidance Documents Committee.

Risk Analysis and Annual Training Program Definition

by Luca Falce
This article presents an example of risk analysis.

How Type I Error Impacts Quality System Effectiveness

by Jeff Gardner
This article presents how Type I errors when using statistical process controls can negatively impact quality systems and what steps can be taken to reduce this impact.

Digital Image Processing for Bench Scale Cleanability Studies

by Kelly Scalva, Steve Buckingham and Keith Bader
This article is based on a presentation given at the ISPE 2013 Annual Meeting and presents an overview of a novel quantitative method utilizing imaging software combined with tightly controlled variables in lighting, angle, and distance, quantifies the amount of process residue on a surface using high-resolution photographs, to produce statistically significant data.

In This Issue