Procedure for Stability Testing of Orally Inhaled and Nasal Drug Products

1) Purpose

The purpose of this SOP is to define a procedure for conducting stability testing for orally inhaled and nasal drug products (OINDP) in accordance with US FDA guidelines. This ensures that these products maintain their quality, safety, and efficacy throughout their shelf life.

2) Scope

This SOP applies to all personnel involved in the stability testing of OINDP, including formulation development, quality control, and regulatory affairs teams.

3) Responsibilities

Formulation Development Team: Responsible for developing OINDP formulations and selecting appropriate packaging materials.
Stability Study Team: Responsible for conducting stability studies according to approved protocols.
Regulatory Affairs Team: Responsible for ensuring compliance with FDA guidelines and submitting stability data to the regulatory authorities.

4) Procedure

4.1 Protocol Development

4.1.1 Develop a stability testing protocol that includes parameters specific to OINDP,

such as particle size distribution, spray pattern, dose content uniformity, and microbiological quality.

4.1.2 Define storage conditions (e.g., room temperature, accelerated) and testing intervals based on FDA guidelines.

4.2 Sample Preparation and Storage

4.2.1 Prepare samples in their final packaging for stability testing.

4.2.2 Store samples under specified conditions (e.g., controlled room temperature, refrigerated) according to