Procedure for Stability Testing of Drugs for Special Populations

1) Purpose

The purpose of this SOP is to establish a procedure for conducting stability testing of drugs intended for special populations (e.g., pediatric, geriatric, pregnant women) in compliance with relevant regulatory guidelines. This ensures that the drug product maintains its safety, efficacy, and quality for the intended population throughout its shelf life.

2) Scope

This SOP applies to all personnel involved in the stability testing of drug products designed for special populations, including quality control, product development, and regulatory affairs teams.

3) Responsibilities

Clinical Development Team: Responsible for identifying specific requirements for special populations.
Stability Study Team: Responsible for designing and executing stability studies according to the specific needs of the target population.
Regulatory Affairs Team: Responsible for ensuring compliance with relevant regulatory guidelines.

4) Procedure

4.1 Protocol Development

4.1.1 Develop a stability testing

protocol tailored to the specific requirements of the special population (e.g., different dosage forms, packaging).

4.1.2 Include appropriate test parameters (e.g., dissolution, assay, degradation products) based on the intended use and population.

4.2 Sample Collection and Storage

4.2.1 Collect samples from each batch of the drug product intended for the special population.

4.2.2 Store samples under