Emprove risk assessment program provides easy access to information on materials used for drug product manufacturing
Merck has expanded its Emprove risk assessment program to include a selection of products for filtration and single-use processing. The software 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, the Darmstadt, Germany-based firm says.
'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.'
New additions to the Emprove program include 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. The 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, sterilisation 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 centralised 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.