Merck Millipore introduces enhancements to its Emprove program of pharmaceutical raw materials to facilitate risk

The enhancements help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission.

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. The newest enhancements enable the selection of raw and starting materials best suited for applications, based on their risk assessment:

In addition to the currently-available Material Qualification Dossier (formerly referred to as the Basic Dossier) drug manufacturers can obtain two new dossiers for regulatory information. These new dossiers help streamline and accelerate the costly and time consuming information collection and risk assessment process. The Quality Management Dossier is structured according to the new EU guideline 2015/C 95/02 and supports risk assessment and supplier qualification for excipients. With greater detail on raw material properties, the new Operational Excellence Dossier helps drug manufacturers design more consistent and predictable processes and quality. This dossier includes elemental impurity profiles that address the ICH Q3D guideline requirements published in December 2014.

Drug manufacturers have an option to use the new online Emprove Suite Web site. 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, Merck 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 Merck Millipore. The content is invaluable when filing their drug products, resulting in greater confidence and minimized risk throughout the manufacturing process.”

Merck Millipore representatives will be available at stand #7K40 at the CPHI conference in October in Madrid, Spain to discuss the Emprove portfolio and these new enhancements.