Supporting your process: risk assessment guidelines on excipients

At Merck, we strive to stay up-to-date on the latest regulatory proceedings so we can fully support your process – keeping you informed about any changes you need to be aware of, as well as making sure these requirements are followed in the manufacturing of our own products.

In 2013 the EU Commission published guidelines on formalized risk assessment, according to which drug manufacturers need to ascertain the appropriate GMP for the excipients they use.

To achieve this, drug manufacturers must first determine and assess the appropriate GMP based on the type of excipient. The assessment of excipients should consider the risks presented to the quality, safety and function from its source as well as the use of the excipient. This includes an assessment of potential sources of contamination, the use of dedicated equipment and/or facilities, as well as environmental control and storage conditions. Moreover, the excipient manufacturers' risk profile needs to be determined by gathering information on their quality management system. Once this has been established, the application of the appropriate GMP needs to be confirmed.

With these guidelines in mind, Merck is able to help determine our products' risk profile in a number of ways. We haverevised the Quality Self Assessments for our production facilities and provide comprehensive regulatory documentation, for example, through our EMPROVE® dossiers. And as we passed our EXCiPACT™ audit, we are also able to offer an independent third-party certification, which will help you in assessing our risk profile as excipient manufacturer. This demonstrates compliance with the current state-of-the-art GMP and GDP standard for excipients. Additionally, we can help reduce your high audit burden by offering a comprehensive audit report free of charge.

Excipact is a registered trademark of La Fédération du Conseil International des Excipients Pharmaceutique, Brussels, Belgium.

In This Same Issue:

• ChromaTALK™ moves to LinkedIn®
• Optimize your formulation with synthetic lipids
• New porous silica structure overcomes drug solubility challenges