Volume 23, Number 3
by Sameh Uzzaman
A structured evolutionary approach to CSV
This article gives a practical approach to considering risks to e-records and applying appropriate controls to manage them.
by Ulrich Rudow
Pharmaceutical Engineering interviews Ulrich Rudow, Vice President, Worldwide Engineering, Johnson & Johnson
by Arthur Perez
FDA’s new draft guidance on Part 11 lowers some of the hurdle with which industry has struggled since the rule’s inception in 1997.
by Orlando L
This article covers the FDA regulatory requirements for computer infrastructure and provides recommendations on how to comply with their requirements.
by Tiny Heesen, Rudy Kuijer, Henk Man
S88, a methodology for designing and automating batch processes, enables easier validation, maintenance of the validated state of automated systems, and straightforward development of recipes, which results in a lower total cost of ownership of a multi-product pharmaceutical batch facility, and a shorter time to market of new products and/or product grades.
by Stephen Hall, Andy Stoker
This article discusses some of the more significant developments in API manufacture and supply and explores implications for pharmaceutical engineering.
by Matt Bothe
The GAMP documents, specifically URS and FS, can be used as effective communication tools to establish the necessary dialog between the find user (via URS) and contractors (via FS).
by Brett Belongia, Robert Blanck, Steve Tingley
This article describes an innovative approach to applying single-use disposable fluid path technology to final fill and finish operations.
by Stephan Barp, Jos Corver, Alois Schaelin, Paul Stewart
This article discusses a numerical method to model airflow in cleanroom environment.
NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © ISPE. All rights reserved.)