Procedure for Stability Testing of Drug-Device Combination Products Following ICH Q1A(R2) Guidelines

1) Purpose

The purpose of this SOP is to define the procedures for conducting stability testing on drug-device combination products in accordance with the International Council for Harmonisation (ICH) Q1A(R2) guidelines. This ensures that such 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 drug-device combination products, including formulation development, quality control, and regulatory affairs teams. It covers the entire stability study process, from protocol development to data reporting.

3) Responsibilities

Formulation Development Team: Responsible for developing the drug formulation and device components and selecting suitable packaging materials.
Stability Study Team: Responsible for designing and executing stability studies according to ICH Q1A(R2) guidelines.
Quality Assurance Team: Responsible for reviewing and ensuring that all data

and reports comply with regulatory requirements.

4) Procedure

4.1 Stability Protocol Development

4.1.1 Develop a comprehensive stability testing protocol following ICH Q1A(R2) guidelines, considering both drug and device components.

4.1.2 Define testing parameters such as assay, sterility, moisture content, container integrity, and mechanical performance of the device.

4.2 Sample Preparation and Storage

4.2.1 Prepare samples in the final