Procedure for Stability Testing of Drugs Under Expedited Approval Pathways

1) Purpose

The purpose of this SOP is to define a procedure for conducting stability testing for drugs under expedited approval pathways, ensuring compliance with regulatory requirements while maintaining product quality, safety, and efficacy.

2) Scope

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

3) Responsibilities

Formulation Development Team: Responsible for preparing formulations for expedited stability testing.
Stability Study Team: Responsible for conducting accelerated stability studies according to approved protocols.
Regulatory Affairs Team: Responsible for ensuring data meets the requirements of expedited approval guidelines and submitting stability data to the authorities.

4) Procedure

4.1 Protocol Development

4.1.1 Develop a stability testing protocol tailored to expedited approval requirements, including accelerated and long-term conditions.

4.1.2 Define storage conditions (e.g., 40°C/75% RH for

accelerated, 25°C/60% RH for long-term) and testing intervals (e.g., 0, 1, 3, 6 months) based on regulatory guidelines.

4.2 Sample Preparation and Storage

4.2.1 Prepare samples in their final packaging for stability testing, ensuring that all batches are representative of the final product.

4.2.2 Store samples under specified accelerated conditions, with continuous monitoring to maintain