AET and Ophthalmic Drug Products

June 7, 2018

During the PQRI PODP Workshop at USP Headquarters on April 18-19, the PQRI toxicology sub-team announced that they could not get the FDA to agree to the analytical evaluation threshold (AET) concept for ophthalmic drug products.  FDA felt that the human eye was a unique organ that was especially susceptible to local topical effects and that ocular irritation was a key endpoint to consider.  Therefore, they rejected the use of an AET for reporting leachables.  PQRI ophthalmic drug sub-team stated in their presentation that the “unwritten FDA expectations” for ophthalmic drug packaging systems was that:

  • Leachables be reported at or above 1 ppm
  • Leachables be identified at 10 ppm
  • Leachables be qualified at 20 ppm

PQRI further stressed in this presentation that many pharmaceutical companies actually go above and beyond these FDA expectations and report, identify, and qualify all leachables > 1 ppm for ophthalmic drug products.