BioPharm International-09-02-2006

While not yet finalized and adopted, ICH Q10 represents some of the most current thinking with respect to pharmaceuticals manufacturing and control.

Established, fully validated methodology and SOPs are required prior to initiation of any training activities.

Development reports document process development and support the design of validation experiments, yet in many firms training is not provided nor are expectations established. This article describes how project managers can help scientists master the art of report-writing.

SOPs are written job aids that detail the procedure of how to do a specific job task correctly.

The concept of design space has started a minor revolution in our industry.

Reserve samples of test and control articles must be retained for at least one stability time point after the completion of the study.

The challenge is to determine the optimal frequency for preventive maintenance and the optimal frequency and tolerances for calibration readings.