Leachables and Extractables Workshops

The Product Quality Research Institute (PQRI) completed its work on Recommendations for control of leachables and extractables in orally inhaled and nasal drug products (OINDP) (http://pqri.org/pdfs/LE_Recommendations_to_FDA_09-29-06.pdf).  Based on these Recommendations, a 1.5 day Leachables and Extractables Training Course (http://www.pqri.org/workshops/leach_ext/pqrilandeworkshop.asp) highlighted best practices for leachables and extractables in OINDP. Recommendations for regulatory approaches to leachables and extractables in orally inhaled and nasal drug products developed by the PQRI working group were also presented and discussed at the 2005 PQRI Leachables and Extractables Workshop (http://www.pqri.org/workshops/leach_ext/landedocs.asp).