July/August 2004
Volume 24, Number 4

Theme: Regulatory & Qualification

Table of Contents

Articles

A Practical Approach to Commissioning and Qualification - A Symbiotic Relationship
by Timothy D Blackburn, PE
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.
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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. Download Article...

From Good Manufacturing Practice to Good Manufacturing Performance by Professor Roger S. Benson, FREng and 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. Download Article...

USA/EC/ISO Regulatory Considerations for Designing Aseptic Processing Facilities by Manuel A. Del Valle, PE 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. Download Article...

Validation Outsourcing Best Practices: What Does this Mean for the Client-Contractor Relationship? by Katie Henchir and Cynthia Ingols This article describes the importance of Validation Master Planning as it relates to the success of both project management and contractor coordination. Download Article...

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. Download Article...

Investigation of the Corrosion Characteristic of AL-6XN Fusion Welded to Inconel Alloy 22 by Arnie Grant and 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. Download Article...

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. Download Article...

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