Developing and Using Analytical Methods to Achieve Quality by Design and Efficiency in Drug Development

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

The company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.

The new building expands on the company’s supply chain solutions for biologics and temperature-sensitive pharmaceuticals.