Posting Date: 18–Jan–2007
Thursday and Friday, January 18–19, 2007
Bethesda North Marriott Hotel and Conference Center
North Bethesda, MD
USP Summary
Through the efforts of a hard-working planning committee, the USP/PDA Joint Conference: Residual Solvents concluded a highly successful meeting on January 18–19, 2007, at the Bethesda North Marriott Hotel and Conference Center. Meeting co-chairs were John Towns, representing PDA's Task Force and Thomas Chapman, representing USP's Residual Solvents Project Team.
The meeting was opened by Robert Myers/PDA and Roger Williams/USP, followed by presentations from Michael Morris (European Pharmacopoeia and EMEA Perspectives), Robert Osterberg (ICH Perspective), Todd Cecil (USP Perspective), and Ms. Rosa J. Motta (FDA Perspective). After these introductory overviews, the meeting allowed opportunities for Pharmaceutical Manufacturer (Neil Schwarzwalder/PhRMA, John Kovaleski/GPhA, Tina Engle/CHPA), Supplier (David Schoneker/IPEC) and Contract Laboratory Perspectives (Assad Kazeminy). Subsequent sessions focused on Assessment Strategies, Methods, Alternative Methods, and an Implementation Workshop. While many thought the general approach was well established, deliberations at the workshop suggested that the task of applying the principles of ICH Q3C to all pharmaceutical ingredients and dosage forms, where appropriate, in the US market is not simple.
Key issues emerged from the wrap-up discussion, including the need to consider:
- Risk-based approaches and quality of design concepts of safety versus capability (acceptance criteria);
- When to test, when to test in the context of good process controls (e.g., Process Analytical Technology, Quality by Design), USP implementation dates;
- The challenge of requiring a single compendial analytical procedure;
- FDA review and filing approaches.
USP will continue to advance the documentary and physical standards based on dialogue with involved parties, to include FDA, the USP Residual Solvents Project Team and the PDA Task Force.
Speaker abstracts and PowerPoint presentations including final wrap up slides are posted with this announcement.
Day One: Thursday, January 18, 2007
1. Welcome, Introductions, Goals of the Conference
- Robert Myers, PDA—presentation
- Roger L. Williams, M.D., USP
- Thomas E. Chapman, Ph.D., Meeting Co-chair—presentation
2. Regulatory Perspectives
- Robert E. Osterberg, RPh, Ph.D., ICH Perspective—abstract, presentation
- J. Michael Morris, Ph.D., EMEA Perspective—abstract, presentation
- Rosa J. Motta, FDA Perspective—presentation
3. Background on Residual Solvents
- J. Michael Morris, Ph.D., European Pharmacopoeia Perspective—presentation
- Todd L. Cecil, Ph.D., USP Perspective—presentation
4. Pharmaceutical Manufacturer Perspectives
- Neil A. Schwarzwalder, PhRMA Perspective—abstract, presentation
- John Kovaleski, GPhA Perspective—abstract, presentation
- Tina Engle, CHPA Perspective—abstract, presentation
5. Supplier Perspectives
- Excipients David R. Schoneker, IPEC Perspective—abstract, presentation
6. Contract Lab Perspectives
- Assad J. Kazeminy, Ph.D., Irvine Analyticals—presentation
7. Assessment Strategies to Meet the Requirements
- To Test or Not to Test
Jon N. Cammack, M.S., Ph.D., Baxter—abstract, presentation - Supplier Qualification, Audits, and Acceptance by COA
Susan J. Schniepp, Hospira—abstract, presentation
Day Two: Friday, January 19, 2007
8. Methodologies
- USP Laboratories
Jennifer Belsky, Ph.D., USP—abstract - Industry Laboratories
Ann M. Warner, Ph.D., Eli Lilly—abstract, presentation - Column Manufacturer
- Sky Countryman, Phenominix—abstract, presentation
9. Alternative Methodologies
- Overview and Adopting Alternative Methodologies
Keith Freebairn, Ph.D.,GSK—abstract, presentation - Case Study: Industry Laboratory
Curtis Tinker, BMS—presentation
Implementation Workshop—Ideas for the Future
Meeting participants will interact with USP's General Chapters Expert Committee, Residual Solvents Subcommittee Members (no presentations)
Wrap-up, Discussion, Q&A
Drs. John Towns, Meeting Co-chairs—presentation