May 2005 Issue
Researchers Jeffrey Macher and Jackson Nickerson are analyzing 13 years of FDA inspection data and reams of documentation to help prioritize inspection risks. We offer their initial findings, presented by Macher at last months PDA meeting, as well as the results of Concept Heidelbergs analysis of 2004 FDA warning letters.
SOX is moving from the executive suite down to the plant floor.
Security must be a top priority for drug makers, but overly restrictive noncompete and nondisclosure agreements and publishing practices verge on the paranoid and prevent the exchange of best practices that the industry needs in order to improve.
Predictive models, PAT, and continuous processing promise to reduce variability and improve product quality.
Flexibility is driving more manufacturers to servo-driven packaging lines, but concerns remain about validation and the blue screen of death with PC-based controls.
Pharmaceutical makers pursue more predictive and global technologies to improve output, ensure compliance.
Accumulating buffer systems ensure greater uptime along production lines, reduce product backups and enhance throughput.
Can there be best practices for plant closings?
Used to authenticate products, stable-isotopic analysis can also be used to improve process understanding and control.