July / August 2007

Outsourcing and Contract Manufacturing in the Pharmaceutical Industry
by Magdalena Nannei, Sandra Rumiano
This article reviews the considerations involved to decide whether to outsource any manufacturing activity. Some basics for successful outsourcing are considered. The challenges and benefits of outsourcing, the company’s areas that should be involved in the process, and the activities to be developed are discussed.

“Offshoring” Life Science Production is not the Only Answer
by Roger S. Benson
This article presents an analysis of the manufacturing and supply chain costs and suggests that for true commercial stage manufacturing, offshoring is not the only option for products that are sold in Europe and other Western countries. 

Managing Offshore Outsourced Software Development
by Jan Villumsen
This article focuses on how to run offshore outsourced projects – what makes these projects different, what to be aware of, and how to get organized in an offshore outsourced setup.

Industry Interview Series: Dr. Thomas Zimmer, Senior Vice President of the Corporate Division, Safety, Quality, and Environmental Protection, Boehringer Ingelheim 
The Chair of ISPE’s International Leadership Forum discusses the need for more innovative thinking, the importance of adopting a science- and risk-based approach early in the product life cycle, and the increasing impact of global harmonization.

Risk-Based Equipment Qualification: A User/Supplier Cooperative Approach
by Sandro De Caris, Marco Bellentani, Beny Fricano, Carlo Bestetti, Marco Silvestri, Barbara Testoni
This article presents an efficient cooperative approach to Commissioning and Qualification (C&Q) for manufacturing equipment and covers the entire life cycle for the specification, design, manufacture, installation, commissioning, qualification, operation, and maintenance of the equipment in a risk- based approach. This article is based on work in progress by the GAMP Italia Equipment Validation Workgroup.

Risk Analysis of Transdermal Drug Delivery Systems
by Maziar Kakhi, Suneela Prodduturi, Anna M. Wokovich, William H. Doub, Lucinda F. Buhse, Nakissa Sadrieh
This article presents an application of risk analysis concepts to Transdermal Drug Delivery Systems.

Pharmaceutical Manufacturing: Linking Vision and Decision-Making to Achieve a Roadmap Toward cGMPs for the 21st Century
by Beatrijs Van Liedekerke, Ingrid Maes
This article presents the changing manufacturing environment and how companies can develop an infrastructure to continue to meet their strategic objectives.