Celebrating 10 years of EMPROVE® qualification

In 2004, Merck anticipated the upcoming trend of stricter regulations for excipients that would require drug manufacturers to create more efficient documentation for pharmaceutical products. For this reason, we defined a standard method of providing critical information that customers needed for their qualification activities.

To determine and comprise all regulatory information for excipients, we used a thorough qualification process. In compiling the information in Chapter 3 of the CTD format that is recognized globally and facilitates our customers' work, the EMPROVE® dossier was born. The next step was to develop three pillars, based on the application of our materials, to meet the corresponding regulatory requirements: EMPROVE® api for active pharmaceutical ingredients, EMPROVE® bio for biopharmaceutical production and EMPROVE® exp for excipients.

Ten years later, the EMPROVE® portfolio is still going strong with now over 400 products, enabling customers to obtain the documentation for approvals they need to bring products to market faster. Recently, we've added additional information on EMPROVE® products in the form of product quality reports, which show the consistent quality of our produced batches. What's more, we have also enhanced our supply chain information, giving transparency to customers and supporting them in GDP requirements. Additionally, we are in the process of collecting information on elemental impurities levels of EMPROVE® products and are prepared to start compiling the information product by product as soon as the ICH guideline is published.

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