Procedure for Stability Testing According to Regional Regulatory Guidelines

1) Purpose

The purpose of this SOP is to define a procedure for conducting stability testing for drug products in compliance with various regional regulatory requirements. This ensures that products meet the specific stability standards set by different regulatory bodies.

2) Scope

This SOP applies to all personnel involved in the stability testing of drug products intended for different regional markets, including formulation development, quality control, and regulatory affairs teams.

3) Responsibilities

Regulatory Affairs Team: Responsible for understanding regional regulatory requirements and ensuring compliance in stability protocols.
Stability Study Team: Responsible for conducting stability studies according to the approved regional protocols.
Quality Assurance Team: Responsible for verifying data integrity and ensuring compliance with all regional guidelines.

4) Procedure

4.1 Protocol Development

4.1.1 Develop a stability testing protocol that meets the specific requirements of all target

regulatory authorities, including storage conditions and testing intervals.

4.1.2 Address parameters such as assay, impurity profile, dissolution, and physical characteristics.

4.2 Sample Preparation and Storage

4.2.1 Prepare samples in their final packaging for stability testing, ensuring compliance with regional requirements.

4.2.2 Store samples under specified conditions according to each regional guideline, with continuous monitoring of storage