Volume 30, Number 4

Table of Contents

Articles

Quality by Design using an Integrated Active Pharmaceutical Ingredient – Drug Product Approach to Development

by Vince McCurdy, Mary T. am Ende, Frank R. Busch, Jason Mustakis, Peter Rose, and Mark R. Berry
This case study demonstrates how Quality by Design transcends API synthesis through to the final drug product.

Virtualization – Compliance and Control

by Ulrik Hjulmand-Lassen
This article presents the advantages and risks associated with the use of virtualization techniques in regulated areas and provides a list of quality focus issues to review, as a prerequisite to avoid the most likely pitfalls.

Process Transfer to Contract Manufacturing Organizations: A Case Study on Process Development Support Past Regulatory Approval

by Amy Webb, David H. Reifsnyder, and Jean Bender
This article presents a process transfer case study and the significance of continued project support after the site is licensed.

Computational Fluid Dynamics as a Tool for Designing Quality into the Pharmaceutical Cleanroom

by John Gafford, Jesse Roberts, and Joe Sullivan
This article presents three different case study applications of CFD modeling.

Industry Forces Driving Standardization of the Turnover Package

by Roy F. Greenwald and Bill Schaidle
This article provides an overview of the past and present approaches to formatting of turnover packages for equipment and modular assemblies. It highlights the lack of standardization within the industry and presents an example of an approach that could serve as a starting point for an industry standard.

Engineering Information Management – Electronic Project Data from Design through Delivery

by Robert Velén, Dennis Naughton, and Rolf Strömgren
This case study explores lessons learned in data delivery from a decade of facility projects between Eli Lilly (facility owner) and Pharmadule (contractor), focusing on their latest project in Ireland. Perspectives from both the facility owner and contractor are provided.

Departments

ISPE Update - Risk-MaPP Guide to Provide Scientific, Risk-based Approach to Managing Risk of Cross Contamination - New Knowledge Brief - ISPE Participants First to Hear Details of CDER Update on Part 11 - New on ISPE.org: Comprehensive GMP Resources - ISPE Brussels Conference to Focus on Risk-based Control Strategies in Pharmaceutical Industries

Classified Advertising with Advertiser’s Index

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