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WorldWIDE

REGULATORY GUIDANCE

At present, there are no worldwide standards that are specifically applicable to Orally Inhaled and Nasal Drug Products (OINDPs). Below are regulatory agencies by region, a harmonizing organization, and selected recommended guidelines for safety, quality and efficacy.

Regulatory guidelines for in vitro testing of OINDPs include general descriptions for characterizing OINDP performance under fixed laboratory conditions to determine certain end-point oriented critical quality attributes (CQA) that drive product quality. Proveris instruments can perform these tests on a range of devices through the life of the device. Below are some of the commonly accepted tests:

  • Single Actuation Container (SAC) Through Life
  • Aerodynamic Particle Size Distribution (APSD) by Cascade Impaction (NGI, ACI)
  • Spray Pattern
  • Plume Geometry
  • Priming/Re-priming
  • Delivered Dose Uniformity
  • Valve/Pump Delivery (Shot Weight)
  • Drug Particle Size by Microscopy (Suspensions)
  • Droplet Size Distribution (DSD) by Laser Diffraction
  • Product Wasting for Through Life Testing

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