July/August 2005 Volume 25, Number 4



A Practical Guide to Construction
by Wael Allan, Andrew D. Skibo
This article focuses on construction contractors who can deliver qualified facilities and presents the advantages of using a construction contractor who can perform Commissioning and Qualification.
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Elicitation of Expert Knowledge about Risks Associated with Pharmaceutical Manufacturing Processes
by Nga L. Tran, Brian Hasselbalch, Kara Morgan, Gregg Claycamp
This article describes the development, implementation, and results of an expert elicitation survey about risks associated with pharmaceutical manufacturing processes, and discusses potential application of this data collection methodology to a broader range of experts.
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A Precedent for Risk-Based Regulation?
by Jonathan Coburn, Stanley H. Levinson, Greg Weddle
This article compares “risk-based” regulation as a new concept in the pharmaceutical industry against 30 years of experience in the nuclear power industry.
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Design Qualification in Practice – from Strategy to Report
by Yossi Chvaicer
This article presents a practical model for design qualification under a pre-established strategy framework.
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Project Management of Automated Systems Validation
by Jim Verhulst
This article focuses on validating process automation systems for a typical batch biopharmaceutical project and presents new ways to think about organizing the effort. In addition, it defines a typical framework of related documents needed for success, and describes new practices and tools needed to manage the inherent complexity of these projects.
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Microwave Extraction of Antioxidant Components from Rice Bran
by W.H. Duvernay, J.M. Assad, C. M. Sabliov, M. Lima, Z. Xu
This article discusses the assessment of extraction temperature and time for the microwave extraction of rice bran oil and vitamin E yield
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ISPE Professional Certification Program: Raising the Image of the Pharmaceutical Profession
by Jerry Roth, Director of Professional Certification
This article describes the ChPP credential and the next milestone in its development.
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Country Profile: United States - July/August 2005
by United States Affiliate
This section takes a look at the pharmaceutical industry in the United States of America.
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