Procedure for Stability Testing of Non-Oral Dosage Forms

1) Purpose

The purpose of this SOP is to establish a procedure for conducting stability testing of non-oral dosage forms (e.g., injectables, topical, inhalation) in compliance with relevant regulatory guidelines. This ensures that these products maintain their intended quality, safety, and efficacy throughout their shelf life.

2) Scope

This SOP applies to all personnel involved in the stability testing of non-oral dosage forms, including quality control, product development, and regulatory affairs teams.

3) Responsibilities

Formulation Development Team: Responsible for developing non-oral formulations and selecting suitable packaging.
Stability Study Team: Responsible for conducting stability studies as per approved protocols.
Regulatory Affairs Team: Responsible for ensuring compliance with regulatory requirements.

4) Procedure

4.1 Protocol Development

4.1.1 Develop a stability testing protocol that includes specific parameters for non-oral dosage forms (e.g., sterility, pH, viscosity).

4.1.2 Define storage conditions (e.g., room

temperature, refrigerated) and testing intervals.

4.2 Sample Preparation and Storage

4.2.1 Prepare samples in their final packaging for testing.

4.2.2 Store samples under specified conditions according to regulatory guidelines.

4.3 Conducting Stability Tests

4.3.1 Perform stability tests at defined intervals to assess product stability.

4.3.2 Record all data accurately and ensure compliance with approved protocols.

4.4 Data Analysis and