Merck Millipore, the life science business of Germany's Merck KGaA (MRK: DE), has introduced enhancements to its program of pharmaceutical raw materials.
The Emprove portfolio includes around 400 raw and starting materials used in pharma manufacturing, and have now been given expanded dossiers and instantly-accessible online technical and regulatory information. The expanded documentation and regulatory information facilitates drug product manufacturers’ risk assessment workflows and supplier qualification. They also help drug product manufacturers meet their own internal guidelines and the recently-published European Commission guidelines, the company notes.
There are two new dossiers available on top of the Material Qualification Dossier, which help streamline and accelerate the information collection and risk-assessment process. The Quality Management Dossier is structured according to the new European Union guideline and supports risk assessment and supplier qualification for excipients. The new Operational Excellence Dossier helps drug manufacturers design more consistent and predictable processes and quality.
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