LEACHABLES AND EXTRACTABLES

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). Based on these Recommendations, a 1.5 day Leachables and Extractables Training Course highlighted best practices for leachables and extractables in OINDP. Further information about L&E Training Course, including program and presentations, is contained here. 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. The origins of the PQRI work can be traced to the IPAC-RS collaboration with the Inhalataion Technology Focus Group (ITFG) of the American Association of Pharmaceutical Scientists. The ITFG/IPAC-RS Collaboration submitted its technical paper, Leachables and Extractables Testing: Points to Consider to the Agency on 27 March 2001. The paper offers recommendations regarding leachables and extractables in the FDA’s two draft CMC guidances for MDIs/DPIs and nasal spray/inhalation solution, suspension, spray drug products. In particular the Collaboration proposes (i) clarification and consolidation of requirements for leachables and extractables; and (ii) reporting and qualification thresholds for leachables.

The subject of reporting and qualification thresholds for leachables was subsequently addressed by scientists from industry, the FDA, and academia through PQRI.