Procedure for Stability Testing of Biosimilars

1) Purpose

The purpose of this SOP is to establish a procedure for conducting stability testing for biosimilar products in compliance with the World Health Organization (WHO) guidelines. This ensures that biosimilars maintain their quality, safety, and efficacy throughout their shelf life.

2) Scope

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

3) Responsibilities

Biosimilars Development Team: Responsible for developing biosimilar formulations and selecting suitable packaging.
Stability Study Team: Responsible for conducting stability studies as per WHO guidelines.
Regulatory Affairs Team: Responsible for ensuring compliance with WHO guidelines and submitting stability data to relevant authorities.

4) Procedure

4.1 Protocol Development

4.1.1 Develop a stability testing protocol that includes parameters specific to biosimilars, such as potency, purity, degradation products, and immunogenicity.

4.1.2 Define storage conditions (e.g., refrigerated,

frozen) and testing intervals based on WHO guidelines.

4.2 Sample Preparation and Storage

4.2.1 Prepare samples in their final packaging for stability testing.

4.2.2 Store samples under specified conditions according to the protocol.

4.3 Conducting Stability Tests

4.3.1 Perform stability tests at all required intervals.

4.3.2 Document all data accurately and ensure compliance with the approved protocol.

4.4 Data