July/August 2005
Volume 25, Number 4

Theme: Documentation

Table of Contents

Articles

A Practical Guide to Construction, Commissioning and Qualification Documentation – and its Critical Role in Achieving Compliance
by Wael Allan and 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 Dr. Nga L. Tran, Brian Hasselbalch, Dr. Kara Morgan, and Dr. 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. Download Article...

A Precedent for Risk-Based Regulation? by Jonathan Coburn, Stanley H. Levinson, PhD, PE, and 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. Download Article...

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. Download Article...

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. Download Article...

Microwave Extraction of Antioxidant Components from Rice Bran by W.H. Duvernay, J.M. Assad, C. M. Sabliov, M. Lima, and Z. Xu This article discusses the assessment of extraction temperature and time for the microwave extraction of rice bran oil and vitamin E yield Download Article...

ISPE Professional Certification Program: Raising the Image of the Pharmaceutical Profession by Jerry Roth, PE, ISPE Director of Professional Certification This article describes the ChPP credential and the next milestone in its development. Download Article...

Country Profile: United States by ISPE United States Affiliate This section takes a look at the pharmaceutical industry in the United States of America. Download Article...