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Merck improves manufacturing program

Published on 13/10/15 at 10:18am

Merck Millipore, the life science business arm of Merck KGaA, has introduced enhancements to its Emprove portfolio of raw pharmaceutical materials. 

The program has been expanded with documentation and regulatory information to facilitate drug product manufacturers’ risk assessment workflows and supplier qualification. 

The Emprove portfolio includes some 400 raw and starting materials used in the manufacture of drug products and includes excipients, process chemicals and active pharmaceutical ingredients. 

Andrew Bulpin, executive vice president of process solutions at Merck Millipore, says: “The global pharmaceutical industry adheres to the strictest standards, and risk assessment plays a critical role in supplier qualification. 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 minimised risk throughout the manufacturing process.” 

The European Commission was the first regulatory body to formalise risk assessment requirements for pharmaceutical excipients, despite the practice being common in industry, and Merck believes these enhancements will help deliver on these regulations. 

The newest improvements enable the selection of raw and starting materials best suited for applications, based on their risk assessment. The Emprove program’s essential products are targeted at moderate risk level applications. Expert products are specified for higher-risk applications where low microbiological and endotoxin levels are critical. Their manufacturing processes are designed to create products with low microbiological and endotoxin levels. 

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. 

Yasmita Kumar

 

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