EMD Millipore Enhances Emprove Program

EMD Millipore, the life science business of Merck KGaA of Darmstadt, Germany, has introduced enhancements to its Emprove portfolio of pharmaceutical raw materials. The expanded documentation and regulatory information facilitates drug product manufacturers’ risk assessment workflows and supplier qualification. The enhancements also help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission. This was the first regulatory body to formalize risk assessment requirements for pharmaceutical excipients, despite the practice being common in industry. 

The Emprove portfolio includes approximately 400 raw and starting materials used in the manufacture of drug products and includes excipients, process chemicals and active pharmaceutical ingredients.

Drug manufacturers have an option to use the new online Emprove Suite website. This platform provides product information and dossiers for the entire Emprove portfolio and enables direct, 24/7 access to the comprehensive regulatory information.

“The global pharmaceutical industry adheres to the strictest standards, and risk assessment plays a critical role in supplier qualification,” said Andrew Bulpin, executive vice president, process solutions, EMD Millipore. “With these enhancements, customers can continue to rely on the Emprove documentation to guide, facilitate and speed their process of qualifying raw materials from EMD Millipore. The content is invaluable when filing their drug products, resulting in greater confidence and minimized risk throughout the manufacturing process.”