The December 9th webinar will provide updates from the U.S. Pharmacopeia (USP) efforts to develop and implement standardized System Suitability Standards (SSS) for Extractables and Leachables (E&L) testing, addressing the lack of global regulatory guidance and variability in data quality. Initiated in 2021, the project involved extensive stakeholder engagement, laboratory studies, and a global round-robin study across 13 labs using GC-MS and LC-MS platforms. The standards aim to ensure instrument performance and data reliability through carefully designed compound mixtures. Based on feedback and study results, the mixtures were re-optimized and stability-tested, with plans for industry release in Q3 2026 and potential inclusion in USP General Chapter <1663>. The presentation also highlights ongoing efforts to develop standards for rubber oligomers and materials of construction (MOC), and updates to enhance the USP leachables General Chapter <1664> for various dosage forms, reinforcing USP’s commitment to enhancing patient safety and regulatory harmonization.

Speakers:

• Dr. Ravi Kiran Kaja – Senior Principal Scientist, Complex Generics – Science, General Chapters, USP
• G. Prabhakar Reddy, Ph.D. – Senior Director of Pharmaceutical Sciences, General Chapters & Complex Generics, USP