The Leachables and Extractables WG is developing reporting and qualification thresholds for leachables in orally inhaled and intranasal drug products.
Draft Guidance for Industry-Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documents (1998). http://www.fda.gov/cder/guidance/2180dft.pdf
Final Guidance for Industry-Nasal Spray Drug Products Chemistry, Manufacturing, and Control Documentation (2002) http://www.fda.gov/cder/guidance/4234fnl.pdf
“Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products: An Overview of the PQRI Recommendations”, Pharm Research, 25(4), 727-739 (2008) is available in full on the Open Access link at http://www.springerlink.com/content/m4352271h4856p67/?p=eb4f04ace7e84033a1807a710c7bc01a&pi=1
Work Plan
Development of Scientifically Justifiable Thresholds for Leachables and Extractables (PDF)
Meeting Minutes
- January 14, 2005 (PDF)
- December 17, 2004 (PDF)
- December 1, 2004 (PDF)
- October 7, 2004 (PDF)
- October 5, 2004 (PDF)
- October 1, 2004 (PDF)
- September 28, 2004 (PDF)
- August 9, 2004 (PDF)
- July 13, 2004 (PDF)
- July 9, 2004 (PDF)
- May 17, 2004 (PDF)
- April 20, 2004 (PDF)
- April 16, 2004 (PDF)
- April 1, 2004 (PDF)
- March 24, 2004 (PDF)
- March 16, 2004 (PDF)
- February 2, 2004 (PDF)
- January 23, 2004 (PDF)
- November 19, 2003 (PDF)
- November 10, 2003 (PDF)
- September 23, 2003 (PDF)
- September 10, 2003 (PDF)
- August 19, 2003 (PDF)
- August 4, 2003 (PDF)
- July 2, 2003 (PDF)
- April 30, 2003 (PDF)
- April 16, 2003 (PDF)
- April 9, 2003 (PDF)
- April 7, 2003 (PDF)
- April 3, 2003 (PDF)
- March 7, 2003 (PDF)
- February 28, 2003 (PDF)
- February 26, 2003 (PDF)
- February 21, 2003 (PDF)
- January 29, 2003 (PDF)
- January 28, 2003 (PDF)
- January 23, 2003 (PDF)
- January 9, 2003 (PDF)
- December 11, 2003 (PDF)
- December 17, 2002 (PDF)
- December 4, 2002 (PDF)
- November 12, 2002 (PDF)
- October 24, 2002 (PDF)
- September 20, 2002 (PDF)
- July 26, 2002 (PDF)
- July 3, 2002 (PDF)
- July 2, 2002 (PDF)
- June 20, 2002 (PDF)
- May 31, 2002 (PDF)
- May 8, 2002 (PDF)
- April 22, 2002 (PDF)
- April 9, 2002 (PDF)
- February 14, 2002 (PDF)
- January 22, 2002 (PDF)
- December 17, 2001 (PDF)
- November 30, 2001 (PDF)
- November 16, 2001 (PDF)