Fast tracking: Australian pharmaceutical maker automates regulatory compliance with MES

MBT Staff -- Manufacturing Business Technology, 10/3/2007

Sigma Pharmaceuticals Ltd., a leading Australian pharmaceutical manufacturer, has automated its regulatory compliance processes by adopting a manufacturing execution system (MES) with electronic batch record (eBR) capabilities.

The implementation of the XFP-MES from Elan Software at the Sigma Pharmaceuticals Dandenong site also represents the first application of a commercially available MES in the Australian pharmaceutical market.

The Elan solution generates eBRs documenting every action performed by Sigma’s dispensing, manufacturing, and clean-in process (CIP) systems. The eBRs are essentially electronic copies of the standard paper-based batch records that most pharmaceuticals manufacturers use to control manufacturing processes. The advantages of eBRs include:
• Better traceability through the use of electronic signatures, security, and bar coding;
• Improved process repeatability due to stricter control of key process parameters; and
• Simpler review, cross-referencing, and storage of batch information.

“The implementation of the Elan Software EBR system, tightly integrated with Sigma’s ERP and automation layers, has demonstrated true MES, replacing cumbersome paper based-traceability with electronic work instructions,” says Ken Maxwell, project director at Dickinson Autocon Systems, the systems integrator that assisted Sigma with the implementation. “This allows a common validated record of all manufacturing steps with genealogy tracking enabling Sigma to achieve the highest regulatory compliance, and drastically improve batch-release times.”