Reimagining How You Work with Your Excipient Supplier: Product Quality Beyond Compendial Requirements

This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme.

One of the top priorities of pharmaceutical companies in bringing new products to market is to prove a drug substance is safe and effective against a certain illness.

As you would expect, especially in the beginning stages of development, companies primarily focus on the API itself and not necessarily the excipients that will go into the final drug product. Instead, compendial requirements and guidelines such as those from ICH exist to ensure excipient quality and safety.

Not only this is important from a regulatory perspective, but excipient quality can also impact product performance, even if those excipients meet all compendial requirements. In this session, you will learn about:

Recent regulatory developments relating to residual impurities in pharmaceutical excipients

Challenges in analytical methods to meet increasingly stringent targets

How you can work with your excipient supplier to ensure high product quality