Volume 30, Number 6

Table of Contents

Articles

Risk-Based MES Implementation Using Hazard Analysis and Critical Control Points (HACCP)

by Tineke Bos, Paul Irving, and Philip Rees
This article presents the benefits of replacing a paper-based production system with Manufacturing Execution System (MES).

Applying GAMP^® 5 to Validate an ERP System

by Stephen R. Ferrell
This article discusses how the GAMP 5 quality risk management strategy was applied to an actual case study of a validated Enterprise Resource Planning (ERP) system.

Scaling of Quality Measures When Using a Configurable Manufacturing Execution System

by Rolf Blumenthal
This article focuses on scalability of activities in the life cycle of computerized systems and outlines the level of service standards that pharmaceutical customers can expect from computer system suppliers.

Industry Interview Series: Dr. Johannes Roebers, Senior Vice President, Head of Biologic Strategy, Planning and Operation, Elan Pharmaceutical International Ltd.

by Catherine Middelberg
Dr. Johannes Roebers provides insight into Elan’s work on current and potential therapies for Alzheimer’s, Parkinson’s, and Multiple Sclerosis and discusses the state of biosimilars today.

IT Outsourcing and Offshoring: Recognizing and Managing Risk

by Arthur D. Perez, PhD and Glenn Morton
This article discusses risks and mitigation strategies that need to be considered between healthcare companies and outsourced IT suppliers.

Departments

Global Regulatory News

ISPE Update

- Discovering the True Value of Membership - GAMP Documents Update - PQLI Update from Brussels: Case Studies in QbD for Biotechnology and Small Molecule Product Realization - Introducing the 2010-2011 Board of Directors - What is the CPIP Certification and What are the Benefits? - Pharmaceutical Engineering Announces Winner of the Article of the Year Award 

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