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

Abstract

In response to the Food and Drug Administration's (FDA's) Draft Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls (CMC) Documentation (1), a technical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 MDIs 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.

The team believes that only those tests that have been demonstrated in development studies to provide meaningful information about quality should be included as product quality control tests. The team analyzed the tests required by the draft guidance from this perspective. This article summarizes the results of the team's investigation and provides a critical assessment of how individual tests can add value to the development and quality control of a new product. The goal of the team's initiative is to maximize the value of characterization and control testing, and to minimize testing that does not provide useful information.