Volume 22, Number 5 Table of Contents Articles Process Containment Design for Development Facility - Part 2 by Lewis Walker This article discusses the problems associated with handling of potent solids in development...
Volume 23, Number 4 Table of Contents Articles Country Profile: Singapore - July/August 2003 by Singapore Affiliate This section takes a look at the pharmaceutical industry in Singapore; produced in collaboration with...
Volume 23, Number 3 Table of Contents Articles Computer Systems Validation: A Systems Engineering Approach. by Sameh Uzzaman A structured evolutionary approach to CSV Risk Assessment for Use of Automated Systems...
Volume 23, Number 2 Table of Contents Articles Country Profile: Japan - March/April 2003 by Japan Affiliate This section takes a look at the pharmaceutical industry in Japan; produced in collaboration with ISPE Japan...
Volume 23, Number 1 Table of Contents Articles The ANSI ISA S88.01 Standard: A Case Study of its Application in the Pharmaceutical Industry by M. Mangiarotti, M. Rizzi A modular management production system based on the...
Volume 22, Number 6 Table of Contents Articles A Prescription for Chemical Management: Beyond Compliance in 2002 by Mark Wysong In the pharmaceutical manufacturing environment where competitive strategies focus heavily...
Volume 22, Number 4 Table of Contents Articles Process Containment Design for Development Facility - Part 1 by Lewis Walker This article discusses the problems associated with handling of potent solids in development...
Volume 22, Number 3 Table of Contents Articles Containment Considerations by James P. Wood This article highlights key elements to consider in approaching the containment of pharmaceutical operations. Silicone Use: The...
Volume 22, Number 2 Table of Contents Articles Pharmaceutical Supply Chain Challenges by Arthur St. Onge, Sean O. O This article investigates the dual challenges to the Pharmaceutical Supply Chains; the cost cutting...
Volume 22, Number 1 Table of Contents Articles The Role of Process Simulation in Pharmaceutical Process Development and Product Commercialization by Demetri P.Petrides, Alexandros Koulouris, Pericles T. Lagonikos This...
Volume 21, Number 6 Table of Contents Articles Reducing Energy Costs in a Central Utility System through Optimization: Impact for a Pharmaceutical Company by Eric Unrau, John Havener This article describes how...
Volume 21, Number 5 Table of Contents Articles Biotech Manufacturing: Is the Crisis Real? by Jeffery Odum This study focuses on development of models to evaluate a predicted manufacturing short fall. Comparison of High...
Volume 21, Number 4 Table of Contents Articles An Interview with the Founders of Clark by Doyle Clark, Gerry Richardson, Jeff Biskup The founders of CRB, Doyle Clark, Gerry Richardson, and Jeff Biskup, discuss the...
Volume 21, Number 3 Table of Contents Articles Reasons by Brian W. Saxton This article discusses what are the elemental requirements of a Validation Master Plan, what it should look like, what the FDA expects, and what...
Volume 21, Number 2 Table of Contents Articles Addressing 21 CFR Part 11 Requirements with an Automated Configuration Audit Trail and Version Management System by David Deitz This article describes a computer based...
Integrated Strategic Planning: New Horizons for Infrastructure by David M. Jonik, Gary D. Anderson The process of physical planning should provide a means of advancing strategic corporate goals, leading to sustainable...
Operation and Maintenance of Process Control Systems in the Pharmaceutical Industry by Volker Teuchert This article presents a summary of VDI/VDE 3517, Part 4: Operation and Maintenance of Validated Systems (ongoing...
Communication Failure Equals Project Failure by James E Teigen This article presents examples of project problems caused by lack of communication, and how increasing communication can minimize these problems. Meeting the...