Issue Date: July 5, 2002
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Final
Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products–Chemistry, Manufacturing, and Controls Documentation: Guidance for Industry
This document provides guidance for industry on the chemistry, manufacturing, and controls (CMC) documentation that should be submitted in new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for nasal spray and inhalation solution, suspension, and spray drug products intended for local and/or systemic effect. This guidance covers CMC information recommended for inclusion in the application regarding the drug product components, manufacturing process, and associated controls for each of these areas, but does not address the manufacture of drug substances. The guidance also provides recommendations on labeling. This guidance does not address propellant-based inhalation and nasal aerosols (also known as oral and nasal metereddose inhalers, MDIs), inhalation powders (also known as dry powder inhalers, DPIs), and nasal powders.
Download the Guidance Document
