Volume 23, Number 3

Table of Contents

Articles

Computer Systems Validation: A Systems Engineering Approach.

by Sameh Uzzaman
A structured evolutionary approach to CSV

Risk Assessment for Use of Automated Systems Supporting Manufacturing Processes

This article gives a practical approach to considering risks to e-records and applying appropriate controls to manage them.

Pharmaceutical Engineering interviews Ulrich Rudow

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

FDA’s New Draft 21 CFR Part 11 Guidance

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FDA’s new draft guidance on Part 11 lowers some of the hurdle with which industry has struggled since the rule’s inception in 1997.

Regulatory Requirements for Computer Infrastructures

by Orlando L
This article covers the FDA regulatory requirements for computer infrastructure and provides recommendations on how to comply with their requirements.

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.

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.

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).

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.

Numerical Simulations to Assess Airflow Behavior in Buffers

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.)