Procedure for Stability Testing for Global Harmonization

1) Purpose

The purpose of this SOP is to define a procedure for conducting stability testing to meet global harmonization requirements as outlined by the International Council for Harmonisation (ICH) guidelines. This ensures that drug products comply with the stability testing standards of multiple regulatory authorities.

2) Scope

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

3) Responsibilities

Regulatory Affairs Team: Responsible for understanding and incorporating ICH guidelines into the stability testing protocols.
Stability Study Team: Responsible for conducting stability studies as per approved protocols.
Quality Assurance Team: Responsible for ensuring that all stability data complies with ICH guidelines and relevant regulatory requirements.

4) Procedure

4.1 Understanding ICH Guidelines

4.1.1 Review and understand the ICH guidelines for stability testing, including

Formulation Characterization and Stability of Protein Drugs

4.1.2 Ensure that testing protocols incorporate all relevant requirements for global markets.

4.2 Protocol Development

4.2.1 Develop a comprehensive stability testing protocol that aligns with ICH guidelines and meets the requirements of all target regulatory authorities.

4.2.2 Define storage conditions, testing intervals, and parameters to be tested.

4.3 Conducting Stability Studies

4.3.1