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.

Leachables and Extractables Handbook

The book, Leachables and Extractables Handbook: Safety Evaluation, Qualification and Best Practices Applied to Inhalation Drug Products has now been published. The book addresses safety and best practices related to leachables and extractables, as well as chapters on inorganic leachables and foreign particles. Also included are the protocols from the PQRI L&E work. Authors include IPAC-RS participants, regulators (FDA and Health Canada), and industry experts from outside of IPAC-RS.

The book is available at Wiley. Please share this link and information with your colleagues.