January / February 2011

January / February 2011 Cover


The Challenges of Regulatory Change Management: Does ICH Quality Trio Provide the Solution?
by Mary Oates, Michael Marini, and Barry McCloy
It is hoped that this article will stimulate the necessary dialogue among industry and regulators to establish the baseline criteria to achieve a system in which the majority of changes can be made globally under the robust quality systems of a firm with total visibility to the health authorities upon request.

Continuous Verification – Providing an Alternative Approach to Process Validation
by Richard Kettlewell, John Upfield, Rosemary Leak, and Andrew Harris
This article presents an innovative approach to the completion of Performance Qualification (PQ).

Risk Management – A Key Requirement for Project Success
by Brett Schroeder, John Alkemade, and Gordon Lawrence
This article discusses how risk management can aid in project success. It looks at the potential gain from good risk management, examines some typical risks that recur regularly on projects, and offers a suggested methodology for managing project risks.

Risk-MaPP, ICH Q9, ASTM 2500 in Action: Project Advantages of Practical Quality Risk Management Approaches
by Brian Andreasen, Jürgen Blasi, Holger Fabritz, Henrik Feldthusen, Niels Guldager, and Gert Moelgaard
This article presents four case studies illustrating a wide range of applications for risk-based approaches in pharmaceutical engineering projects.

A Quantitative Study in Cross Contamination
by Julian Wilkins
This article is based on data acquired during an evaluation of the quantifiable risk of cross contamination in an Oral Solid Dosage (OSD) facility. This article is intended to provide some quantitative data to an area in which perception and not reality is the norm. There is really no published data on cross contamination. 

Risk Assessment on Capital Equipment Planning for the Biotech and Pharmaceutical Market
by Mark Mathis
This article presents processes and metrics for identifying and evaluating risks associated with capital equipment planning during the Conceptual Project Planning Phase.