Aerosols–Inhalation and Nasal Drug Products Workshop

Overview

This two-day workshop provided a forum for inhalation drug manufacturers, the FDA, and pharmacopeias to discuss challenges in inhalation and nasal drug product. This was an opportunity to influence USP's future direction on establishing standards for product analysis, particle size measurements, and content uniformity. Read More.

 

  • Following the USP dosage form taxonomy approach, USP proposed a new General Chapter <5> on product quality of inhalation and nasal drug products. This workshop provided an opportunity to discuss this new chapter and its potential impact on inhalation product testing.
  • A revision to USP General Chapter <601> Product Performance Tests for Inhalation and Nasal Drug Products also appeared in Pharmacopeial Forum 37(4). This revision included changes previously recommended by the 2009 USP Aerosols workshop attendees.

Topics:

  • USP taxonomy chart
  • USP's new Chapter <5> Product Quality Tests for Inhalation and Nasal Drug Products
  • General Chapter <601> Product Performance Tests for Inhalation and Nasal Drug Products
  • Efficient Data Analysis (EDA) and Abbreviated Impactor Measurements (AIM)
  • Content uniformity—from Chemistry, Manufacturing, and Controls (CMC) and statistical perspectives
  • Chapter <1601> Products for Nebulization–Characterization Tests, and the stimuli article on spacers

Agenda

When: December 12–13, 2011

Where: USP Headquarters, Meetings Center, Rockville, MD

Participants: Professionals who work in or with

  • Formulation
  • Compliance
  • Engineering
  • Manufacturing
  • QA/QC
  • Regulatory affairs
  • Packaging
  • Research and development
  • Technical operations
  • Validation