May/June 2003
Volume 23, Number 3

Theme: Automation

Table of Contents

Articles

Country Profile: Nordic
by ISPE Nordic Affiliate
This section takes a look at the pharmaceutical industry in The Nordics; produced in collaboration with ISPE Nordic.
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Computer Systems Validation: A Systems Engineering Approach. by Sameh Uzzaman A structured evolutionary approach to CSV Download Article...

Risk Assessment for Use of Automated Systems Supporting Manufacturing Processes, Part 1 – Functional Risk by The ISPE GAMP Forum This article gives a practical approach to considering risks to e-records and applying appropriate controls to manage them. Download Article...

Pharmaceutical Engineering interviews Ulrich Rudow by Ulrich Rudow Pharmaceutical Engineering interviews Ulrich Rudow, Vice President, Worldwide Engineering, Johnson & Johnson Download Article...

FDA’s New Draft 21 CFR Part 11 Guidance by PhD Arthur Perez FDA’s new draft guidance on Part 11 lowers some of the hurdle with which industry has struggled since the rule’s inception in 1997. Download Article...

Regulatory Requirements for Computer Infrastructures by Orlando López This article covers the FDA regulatory requirements for computer infrastructure and provides recommendations on how to comply with their requirements. Download Article...

Good Batch Practice 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. Download Article...

APIs: Current Trends 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. Download Article...

GAMP Life Cycle Documents as Effective Communication Tools 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). Download Article...

Single-Use Disposable Filling for Sterile Pharmaceuticals 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. Download Article...

Numerical Simulations to Assess Airflow Behavior in Buffers by Stephan Barp, Jos Corver, Dr. Alois Schaelin, & Dr. Paul Stewart This article discusses a numerical method to model airflow in cleanroom environment. Download Article...