EMD Millipore Provides Risk-Assessment Information for Raw Materials

EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, the company announced on Sept. 14, 2015. The enhancements facilitate drug-product manufacturers' risk assessment workflows and supplier qualification. This information will also help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission, which 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 APIs. The newest enhancements enable the selection of raw and starting materials best suited for applications, based on their risk assessment, including:

• Emprove Essential products target moderate risk-level applications.

• Emprove Expert products are specified for higher risk applications where low microbiological and endotoxin levels are critical. The manufacturing processes are designed to create products with low microbiological and endotoxin levels.

• Emprove API products provide required API quality and regulatory documentation. GMP requirements are fulfilled, as all products are produced in Europe, according to the ICH Q7 guideline.

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 GxP 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 website. This platform provides product information and dossiers for the entire Emprove portfolio and enables direct, 24/7 access to the comprehensive regulatory information.

Merck Millipore will exhibit at CPhI Worldwide 2015, stand #7K40 in Madrid, Spain on Oct. 13-15.

Source: EMD Millipore