Excipient Quality and Impact on Formulation
The importance of characterizing excipients, supply chain security, and the role of novel excipients are explored.
The recent discovery of probable carcinogens in widely used APIs triggered a wave of drug recalls, increased regulatory oversight, and new testing procedures. Advanced analysis of excipients may reveal previously unknown ingredients; however, such a discovery prompts the need for better understanding of excipient components, the source and safety profiles of the materials, and the role they play in drug performance.
In this Editors’ Series session, moderated by the editors of Pharmaceutical Technology and BioPharm International, an expert panel discusses the characterization of excipient components, understanding regulatory and compendial implications of excipient composition, the global supply chain, effective quality programs and prospects for preapproval of novel excipients.
The panel, featuring Nigel Langley, global technology director, Pharma Solutions, BASF Corporation; David R. Schoneker, president/owner/consultant, Black Diamond Regulatory Consulting, LLC; and Joseph Zeleznik, technical product manager, IMCD US, was recorded during the 2020 Bio/Pharma Virtual Congress on Nov. 11, 2020.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli 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.
