-
APQ Open Forum
Analytical Instrument Qualification: An Update and Current Industry Trend
Thursday, November 15
1:30 pm – 5:00 pm
Funded by Grants from
Analytical instruments are essential tools for the pharmaceutical industry and should be qualified to demonstrate their suitability for the intended use. Process for qualifying instruments has been the subject of much discussion, primarily because of the lack of an authoritative guide for qualifying instruments. Unlike method validation, analytical instrument qualification (AIQ) currently has no specific ICH or FDA guidance. Competing opinions exist regarding instrument qualification and for the role and responsibilities of those who should perform them. Consequently, various approaches generating varying amounts of documentation have been used in the industry to accomplish AIQ. Recently, United States Pharmacopeia issued a draft General Chapter <1058> to provide guidance for AIQ. The draft chapter has been published in Pharmacopeial Forum (latest in PF 32:6) and has gone through multiple cycles of public comments. The chapter is scheduled to become official in 2008 (USP 31). This open forum will discuss the origin, process and implication of the chapter coming into USP. Additionally, some examples of qualifying instruments will be provided, as well as the FDA perspective on qualifying instruments in both QA/QC and bioanalytical laboratories. Panel and the participants would get ample opportunity to share their experiences and views on the process for qualifying instruments with an aim to understand the requirements and establishing uniform process for AIQ that will add scientific value in delivering high quality analysis.
MODERATORS
Saji Thomas, Ph.D.
Par Pharmaceutical
Moheb Nasr, Ph.D.
U.S. Food and Drug Administration
SPEAKERS
How are Clinical Trials in Other Regions Perceived in US Drug Applications
Ni Khin, M.D.
U.S. Food and Drug Administration
Clinical Pharmacology/Toxicology in Regional/Ethnic Patient Populations and Impact on Global Submissions
Jurij Petrin, M.D.
Pharmaceutical Regulatory Services, Inc.
Key Regulatory Challenges
Richard Lowenthal, M.S.
Pacific Link Consulting
Chemistry, Manufacturing and Control Issues with Clinical Trial Materials for New Clinical Sites/Regions
David Bernstein, Ph.D.
Bernstein Consulting
Analytical and Stability Implications for Clinical Trial Materials
Ganapathy Mohan, Ph.D.
Sanofi-Aventis
Panel Discussion
Surendra Bansal (moderator)
Moheb Nasr
Saji Thomas
Nicholas Buhay
Martin Yau
Horacio Pappa
Gregory Martin
