ITFG/IPAC TECHNICAL TEAM:

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ITFG/IPAC TECHNICAL TEAM CMC TESTS
METHODS Presented by Carole Evans, PhD 26
April 2000 Rockville, MD
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OVERALL POSITION ON DRAFT CMC GUIDANCES

• The need for certain tests should be driven by
  evaluation of data generated during the
  development phase of each product.
• In many instances, the language in the draft CMC
  Guidances is ambiguous.
• To clarify testing requirements for each of the
  four OINDP dosage forms, the draft Guidances
  should be edited or a separate Guidance should be
  developed for each dosage form.
• The Team is prepared to work with the OINDP
  Subcommittee and the FDA to facilitate
  harmonization of FDA, USP, and ICH.

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MDI TESTS

• Water (Moisture) Content
• Spray Pattern
• Impurities Degradants
• Pressure Testing
• Plume Geometry
• Particle Size Distribution
• Dose Content Uniformity

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TEAMS APPROACH

• The Team developed working position statements
  for these tests.
• Members plan to collect and evaluate data
  regarding many of these working position
  statements.

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TEAMS COMMITMENT

• The Team will prepare technical papers containing
  any recommendations regarding MDI tests, in the
  next 3-4 months.
• The Team would like to suggest alternate language
  for the draft CMC Guidances to make testing
  criteria specific to particular dosage forms.
• The Team will develop position statements and
  repeat this process for other dosage forms

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TEAMS COMMITMENT
The Team would like the opportunity to share our
recommendations with the OINDP Subcommittee and
the Agency