March / April 2012 Cover


New ISPE President and CEO Sets the Tone for ISPE's Work Ahead
Nancy S. Berg took the helm of ISPE in January as the new President and CEO. In the few weeks since her arrival, she has been working to focus ISPE around its core competencies and key areas for strategic development. This article introduces Berg’s view on the role of ISPE and the important link between Members, leaders, and staff.

Biopharmaceutical Manufacturing in the Twenty-First Century – the Next Generation Manufacturing Facility
by Mark F. Witcher, PhD and Jeff Odum CPIP
This article presents how the next generation of biopharmaceutical facilities can be designed and operated using recent enabling technologies to improve flexibility, decrease COG, and increase throughput of a manufacturing facility.

A Holistic Approach to Pharmaceutical Manufacturing: Product Lifecycle Management Support for High Yield Processes to Make Safe and Effective Drugs
by Julie Fraser and Guillaume Kerboul
This article presents a holistic approach to pharmaceutical manufacturing based on product and process knowledge that allows companies to manage data that improves yields, enhances confidence, identifies risk, and manages the complexity of increasingly personalized medicine.

Application of Pre-Owned Equipment in Pharmaceutical Manufacturing Operations
by Stephan Sirabian, Bob Matje, Jeff Biskup, and Witold Lehmann
This article presents considerations to be made prior to making a capital investment in pre-owned equipment for new or refurbished pharmaceutical facilities.

The U.S. Pharmacopeia (USP) Responds to Changing Needs of Pharmaceutical Manufacturing
by Anthony DeStefano, Antonio Hernandez-Cardosa, Kevin Moore, Tina Morris, Horacio Pappa, and Radhakrishna Tirumalai
This article presents how the U.S. Pharmacopeia (USP) works to ensure the quality of pharmaceuticals by preparing standards.

Industry Interview Series: Dr. Aris Persidis, President and Co-founder, Biovista, Inc.
With patent expirations looming for many major pharmaceutical companies, drug repositioning has become a matter of intense interest during the past few years. Biovista’s President and Co-founder discusses the basics of drug repositioning and the potential impact it could have on bringing new drugs to the market.

Resource Planning in QC Laboratories
by Rafi Maslaton
This article presents a methodology and approach to resource planning, including both analysts and instruments in QC laboratories.

Applying Fault Tree Analysis (FTA) as a Top Level Risk Management Tool in Software Development
by Paul Noble
This article presents the case that fault tree analysis is the better risk analysis method to apply early in software development projects.

Determining Minimum Number of Weigh Rooms to Meet Target Throughput 
by Paul Noble
This article presents a novel way for determining the number of weigh-dispense rooms required to meet the target throughput by employing Formal Concept Analysis (FCA) and Discrete Event Simulation (DES) techniques.