September/October 2002
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 stage manufacture of Active Pharmaceutical Ingredients (APIs). (Part 2 of 2) Download Article...

An MCA Inspection Perspective on Innovation by Anthony Trill This article provides an insight into the MCA Inspectorate’s views on the topic of innovation, based on the author’s industrial and regulatory experience. Proactive relationships and dialogue with focus groups, to enable the implementation of new technology with the support and understanding of the regulatory community are described. Download Article...

Systems Thinking and the Risky Business of Clinical Supplies by Jean Singer This article helps managers to gain a better understanding of how to manage risk by taking a systems thinking perspective. Download Article...

Commissioning - Key to Project Success by Don Owings Commissioning is the key-link between IQ (construction completion) and OQ Validation Execution. Download Article...

Things Go Better with S88: A New Approach to the Engineering Process by Vince Miller ISA/ANSI S88.01 Batch Control Part 1: Models and Terminology can be used to guide the engineering process to develop a modular design, which produces life cycle benefits for the owner. Download Article...

Next-Generation Clinical Supply Chain Management Systems by Douglas Meyer Specific challenges faced by pharmaceutical and biotechnology companies when evaluating and implementing a clinical supply chain system. Download Article...

An Interview with Frank S. Kohn, PhD, former Director of Manufacturing, Wyeth Vaccines by Frank S Kohn, PhD The former Director of Manufacturing for Wyeth Vaccines talks about the changes in the industry over the past several years as well as emerging technologies. Download Article...

Investigation into Protein - Protein Interactions in the Sindbis Virus Membrane Glycoprotein’s which Block Virus Assembly by Katherine Kapfer This article discusses the possibilities of vaccine production through genetic mutations in virus structure. Download Article...

What now, What Next: Pharmaceutical Executives Speak Out by Lynn Ly Johnston Top executives, from pharmaceutical, biotech, and mid-sized companies discuss their perspectives about the state of the pharmaceutical industry and predictions about the next 5-10 years. Download Article...

Designing a Standardized System Qualification Process by Wiebke Herrmann A standardized, comprehensive and clearly structured system for qualifying new and existing production systems is presented. Download Article...

Country Profile: Italy by ISPE Italy Affiliate This section takes a look at the pharmaceutical industry in Italy; produced in collaboration with ISPE Italy. Download Article...