Recommendations to the Food and Drug Administration: Metered Dose Inhaler Tests and Methods in the Chemistry, Manufacturing, and Controls Draft Guidances for Metered Dose Inhalers and Dry Powder Inhalers

In response to the Food and Drug Administration’s (FDA’s) Draft Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls (CMC) Documentation (1), a technical team initiated a scientific evaluation of the tests and methods for MDJs required by that guidance. This technical team was comprised of members of the Inhalation Technology Focus Group (ITFG) of the American Association of Pharmaceutical Scientists and the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). It was called the ITFG/IPAC-RS Tests and Methods Technical Team.