The Leachables and Extractables WG is developing reporting and qualification thresholds for leachables in orally inhaled and intranasal drug products.

Perspectives on the PQRI Extractables and Leachables “Safety Thresholds and Best Practices” Recommendations for Inhalation Drug Products by Daniel L. Norwood, Lee M. Nagao, and Cherry L.M. Stults

Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation 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Draft Guidance for Industry-Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documents (1998).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)