On June 28, 2016 — Merck has expanded its industry-leading Emprove® risk assessment program to include a selection of products for filtration and single-use processing. The program provides documentation and regulatory information on materials used in the manufacture of drug products. This information enhances transparency, facilitates manufacturers’ risk assessment workflows and supplier qualification.
“As the regulatory landscape continues to evolve, rapid and easy access to risk assessment information is even more critical,” said Udit Batra, Member of the Merck Executive Board and CEO, Life Science. “The expansion of our Emprove® program helps ensure our customers are using only the highest quality products for their manufacturing processes.”
The Emprove® program now includes Millipore Express® filters, Pureflex® and Pureflex® Plus bags, Viresolve® Pro filtration devices and Durapore® filters. The program gives customers instant access to online regulatory and technical information on a wide range of products. That information includes details on extractables, residual solvents and elemental impurities for these products. In addition, customers will find labelling information, shelf-life data and procedures, sterilization procedures, packaging testing, audit report summaries and management processes for suppliers.
Using the Emprove® program, manufacturers can download dossiers on material qualification, quality management and operational excellence in one centralized location. In the past, manufacturers had to contact multiple parties for the data. Merck’s data also saves manufacturers time and money associated with their own testing.
The original Emprove® program included more than 400 raw materials and active pharmaceutical ingredients used in manufacturing drug products such as excipients, process chemicals and active pharmaceutical ingredients. The newly expanded program provides industry-leading support to customers by anticipating regulatory needs and delivering confidence that reduces risk throughout the manufacturing process.