Procedure for Stability Testing of Breakthrough Therapy Drugs

1) Purpose

The purpose of this SOP is to establish a procedure for conducting stability testing of breakthrough therapy drugs in compliance with US FDA guidelines. This ensures that these drugs maintain their intended quality, safety, and efficacy throughout their accelerated development and approval process.

2) Scope

This SOP applies to all personnel involved in the stability testing of breakthrough therapy drugs, including formulation development, quality control, and regulatory affairs teams.

3) Responsibilities

Formulation Development Team: Responsible for developing breakthrough therapy drug formulations.
Stability Study Team: Responsible for conducting stability studies as per FDA guidelines.
Quality Assurance Team: Responsible for ensuring compliance with regulatory requirements.

4) Procedure

4.1 Protocol Development

4.1.1 Develop a stability testing protocol tailored to the specific requirements of breakthrough therapy drugs under accelerated timelines.

4.1.2 Include storage conditions, testing intervals, and parameters such as potency,

purity, and degradation products.

4.2 Sample Preparation and Storage

4.2.1 Prepare samples from representative batches in their final packaging.

4.2.2 Store samples under specified conditions (e.g., refrigerated, frozen) per FDA guidelines.

4.3 Conducting Stability Tests

4.3.1 Conduct stability tests at predefined intervals to assess product quality over time.

4.3.2 Record all data accurately and ensure compliance with the