Volume 29, Number 5
by Takayuki Kasai
This article presents key issues in regard to pharmaceutical contract manufacturing.
by Dr. T. R. Ramanathan
This article discusses the nature of organizational change with respect to offshore outsourcing of IT activities in the different Information Systems Departments (ISDs) of a global pharmaceutical company and examines the effectiveness of approaches used to manage this change.
by Ms. Judith Samardelis, Ms. Winnie Cappucci
This article discusses how to apply the GAMP 5 quality risk management strategy to maintain compliance in laboratory computerized systems.
by Mr. Andrew Signore, Mr. Stephen Franey
This article will describe Building Information Modeling (BIM), provide several real-world examples of the advantages that owners have experienced when their projects were designed and developed with BIM, and offer suggestions for minimizing risks and maximizing BIM’s benefits.
by Davide Fissore, Mr. Miquel Galan, Roberto Pisano, Salvatore Velardi, Mr. Antonello Barresi
This article presents an innovative system for in-line process monitoring and control of freeze-drying pharmaceuticals in vials. This system is demonstrated to avoid drying failure in a wide range of operating conditions, as well as to minimize the duration of primary drying.
by Simon Kaye
This article presents new developments in global sourcing logistics and demonstrates how pharmaceutical producers can build an integrated supply and product development strategy.
ISPE’s President reflects on the past 25 years of the Society’s incredible history and discusses the challenge to become truly global; the importance of becoming a trusted technical resource for Members and regulators; and positioning the Society for success in the future.
NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © ISPE. All rights reserved.)