EMD Millipore expands EMPROVE raw-materials portfolio
The expanded portfolio of pharmaceutical raw materials assists drug-product manufacturers' risk assessment workflows and supplier qualifications. The additions also help drug-product manufacturers meet their own internal quality guidelines and those recently published by the European Commission.
"The global pharmaceutical industry adheres to the strictest standards, and risk assessment plays a critical role in supplier qualification," Andrew Bulpin, executive vice president for process solutions at EMD Millipore, said. "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."
The newest enhancements assist in the selection of raw and starting materials that best fit applications, based on the following risk assessment:
• EMPROVE Essential products target moderate risk-level applications.
• EMPROVE Expert products are specified for higher risk applications in which low microbiological and endotoxin levels are critical. The company's manufacturing processes are designed to create products with low microbiological and endotoxin levels.
• EMPROVE API products provide the quality and regulatory documentation required for active pharmaceutical ingredients. GMP requirements are fulfilled, as all products are produced in Europe, according to ICH Q7 guidelines.
EMD Millipore representatives will be available at the CPhI Worldwide 2015 conference in October in Madrid to discuss the EMPROVE portfolio and the new enhancements.