The Impurities WG is determining appropriate methods and extent of characterization for impurities as a function of the stage of product development.
ICH Q3A http://www.fda.gov/cder/guidance/Q3Cfnl.pdf
Impurities Working Group Survey
- PQRI API Impurities Working Group Questionnaire Cover Letter (PDF)
- Impurity Characterization and Quantification Questionnaire (PDF)
Meetings Minutes
- March 11, 2004 (PDF)
- February 10, 2004 (PDF)
- December 9, 2003 (PDF)
- November 12, 2003 (PDF)
- October 16, 2003 (PDF)
- September 23, 2003 (PDF)
- August 12, 2003 (PDF)
- July 14, 2003 (PDF)
- July 14, 2003 (PDF)
- June 10, 2003 (PDF)
- February 11, 2003 (PDF)
- January 14, 2003 (PDF)
- December 10, 2002 (PDF)
- October 30, 2002 (PDF)
- October 8, 2002 (PDF)
- August 20, 2002 (PDF)
- March 12, 2002 (PDF)
- January 29, 2002 (PDF)
- January 11, 2002 (PDF)
- December 11, 2001 (PDF)
- November 6, 2001 (PDF)
- August 21, 2001 (PDF)
- July 11, 2001 (PDF)
- June 28, 2001 (PDF)
- May 24, 2001 (PDF)
- April 17, 2001 (PDF)
- March 20, 2001