New Emprove® program to facilitate risk assessmentIssue: September 29, 2015
| Category: Regulatory Topics
![]() Merck is excited to introduce new enhancements to our Emprove® program of pharmaceutical raw and starting materials. The expanded documentation and regulatory information not only facilitates drug manufacturers' risk assessment workflows and supplier qualification, but also helps meet their internal quality guidelines as well as those recently published by the European Commission. New portfolio categorization and expanded dossiers These enhancements enable the selection of raw and starting materials based on risk assessments. In addition to the currently available Material Qualification Dossier (the former Basic Dossier), two new dossiers, the GxP Dossier and the Operational Excellence Dossier, help streamline and accelerate the costly and time-consuming information collection and risk assessment process. Drug manufacturers will also have the option to use the new Emprove® Suite website. Going live October 12, it will provide product information and dossiers for the entire Emprove® portfolio and enables direct, 24/7 access to comprehensive regulatory information. Visit us at stand #7K40 at CPhI in October in Madrid, Spain to get more information and learn how you can benefit from the new Emprove® program. For more information, please click here In This Same Issue |
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