Merck KGaA Named Winner of the Regulatory Procedures and Compliance Category for the CPhI Pharma Awards

Merck KGaA's life science business (referred to as MilliporeSigma in the U.S. and Canada) was announced the winner of the Regulatory Procedures and Compliance category at the CPhI Pharma Awards gala, held on Oct. 4, 2016 in Barcelona, Spain. The winning entry was the company's Emprove program.

The Emprove program facilitates risk assessment and supplier qualification by providing instant, online access to regulatory and technical information on hundreds of products used in pharmaceutical and biopharmaceutical manufacturing. Recently, the program was expanded to include products for filtration and single-use processing. Information for filtration and single-use products includes details on extractables, residual solvents, and elemental impurities. Customers also have easy access to labelling information, shelf-life data and procedures, sterilization procedures, packaging testing, audit report summaries and management processes for suppliers, all based on rigorous qualification and production processes.

With an increasingly complex regulatory landscape, the Emprove program is structured to address different levels of risk and the dossiers are organized to best meet the requirements of the latest regulations. The program has been providing efficient regulatory documentation to pharma and biopharma for more than a decade.

Without easy access to all this supply chain information, manufacturers have to contact multiple parties to collect necessary information to support their risk assessment programs. The Emprove program saves manufacturers time and money associated with their own testing by giving them access to three different downloadable dossiers in one centralized location:

• The Material Qualification Dossier speeds approval preparation by supporting qualification efforts. It includes content on manufacturing processes, characterizations, certificates, stability summary and more.

• The Quality Management Dossier supports risk assessment by providing information on supply chain, supplier management and product stability.

• The Operational Excellence Dossier supports process optimization activities with/through elemental impurity information (ICH Q3D) and analytical procedures. For filters and single-use components, a comprehensive extractables report is provided.