The enhancements also help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission
Merck Millipore has introduced enhancements to its industry-leading 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 formalise risk assessment requirements for pharma 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 pharma ingredients.
The newest enhancements enable the selection of raw and starting materials best suited for applications, based on their risk assessment. The essential products target moderate risk level applications, expert products are specified for higher risk applications where low microbiological and endotoxin levels are critical. API products provide the quality and regulatory documentation required for active pharma ingredients.
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 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.
EP News Bureau – Mumbai