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)

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.

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.

Commissioning - Key to Project Success

by Don Owings
Commissioning is the key-link between IQ (construction completion) and OQ Validation Execution.

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.

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.

An Interview with Frank S. Kohn

by Frank S Kohn
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.

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.

What Now

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.

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.

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