Topic

Joanne Ratcliff, PhD, is communications project manager, Laboratory Weighing, Mettler Toledo GmbH, Joanne.Ratcliff@mt.com.

Martin Huber, PhD, is head of the GWP competence center at Mettler Toledo, Martin.Huber@mt.com

Articles

The latest revisions to the USP General Chapters <41> Balances and <1251> Weighing on an Analytical Balance aim to ensure weighing accuracy and eliminate unnecessary overtesting by simplifying previous descriptions and reflecting current state-of-the-art weighing practices.

Complying with Revised Weighing Guidelines

Thomas A. Little is president, Thomas A. Little Consulting and BioAssay Sciences, 12401 North Wildflower Lane, Highland, Utah 84003, USA, drlittle@dr-tom.com.

The right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.

Multifactor Non-linear Modeling for Accelerated Stability Analysis and Prediction

The cleaning validation lifecycle includes assessment, development, validation, and monitoring.

Understanding the Cleaning Validation Lifecycle

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.

Defining the Sterile Barrier of Complex Drug Delivery Systems

The root cause of drug shortages is mismanagement of variation.

Separation of Compliance and Performance Under FDASIA

Executive director, PharmaNet Inc., former FDA Investigator

Henrik Johanning is CEO and specialist, Genau & Co, Denmark. He is also a member of Pharmaceutical Technology Europe’s Editorial Advisory Board.

Non-compliance issues show that users find dealing with computer systems challenging.

Checklist for Computer Software Validation

Matt Bundenthal is direct sales and communications manager at Fette Compacting America, www.fetteamerica.com .

Training, calibration, and preventive maintenance help prevent over-and under-weight tablets. The author discusses causes of off-weight tablets and best practices for tableting.

Battling Off-Weight Tablets

Abdennour Bouhroum, PhD, is a Research Fellow at the University of Nottingham.

Analytical tests, correlated with statistical techniques, are used to predict material behavior.

Using Analytical Techniques to Examine Tablet Sticking

An operational-excellence initiative increased collaboration between operations and quality personnel to address human-error-caused deviations.

Operational Excellence Improves Quality and Compliance

John Anderson is a quality assurance and validation professional with years of inspection experience.

Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.

Troubleshooting