Volume 24, Number 4

Table of Contents

Articles

A Practical Approach to Commissioning and Qualification - A Symbiotic Relationship

by Timothy D Blackburn
This article offers a practical approach to commissioning and a method of synergy with qualification. Practical applications are explored, as well as the use of Enhanced Commissioning Documentation to minimize the qualification effort.

PAT, HACCP, and Six Sigma - Making Sense of it All

by George R. Johnson
This article explores the potential impact of PAT, HACCP, and Six Sigma on the Life Sciences Industry.

From Good Manufacturing Practice to Good Manufacturing Performance

by Professor Roger S. Benson, Jim D.J. McCabe
This article was adapted from a presentation at the 2003 ISPE UK Affiliate Annual Seminar, Manchester. It demonstrates how the pharmaceutical industry is capable of improved manufacturing performance.

USA/EC/ISO Regulatory Considerations for Designing Aseptic Processing Facilities

by Manuel A. del Valle
This article presents cleanroom classifications as defined in ISO 14644 and FED STD 209E and their application for designing aseptic processing pharmaceutical/biotechnology facilities as defined in both USA cGMPs and European Community GMPs.

Validation Outsourcing Best Practices: What Does this Mean for the Client-Contractor Relationship?

by Katie Henchir, Cynthia Ingols
This article describes the importance of Validation Master Planning as it relates to the success of both project management and contractor coordination.

Commissioning and Time-To-Market

by Wael Allan
This article describes how a properly planned and executed commissioning strategy can eliminate downstream problems and accomplish much of the data required for qualifications and plant delivery.

Investigation of the Corrosion Characteristic of AL-6XN Fusion Welded to Inconel Alloy 22

by Arnie Grant, John Jermain
This article describes the results of the electrochemical corrosion testing of the as welded, mechanically polished, and electropolished AL-6XN fusion welded to Inconel 22. Also tested was a single electropolished weld segment, which was submerged in a ferric chloride solution in accordance with the ASTM G-48 procedure to further elucidate corrosion resistance and sites of attack.

Increasing Alkaloid Production from Catharanthus roseus Suspensions through Methyl Jasmonate Elicitation

by Jennifer L. Gaines
This article describes the effects of methyl jasmonate elicitation on the alkaloid production of Catharanthus roseus cell suspensions.

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