Stability Trend Analysis in Formulation Development

1) Purpose

The purpose of this SOP is to establish procedures for conducting stability trend analysis in formulation development, monitoring the stability of drug products over time, identifying degradation trends, and ensuring product quality and safety.

2) Scope

This SOP applies to the stability testing and trend analysis activities conducted within the formulation development department of the organization, covering stability studies for drug products under accelerated, long-term, and intermediate conditions.

3) Responsibilities

The responsibilities for this SOP include:
Formulation Development Team: Designing stability studies, conducting trend analysis, and interpreting stability data.
Quality Assurance: Reviewing stability protocols, monitoring study progress, and ensuring compliance with regulatory guidelines.
Analytical Development: Developing stability-indicating methods, performing testing, and analyzing stability samples.
Regulatory Affairs: Providing regulatory guidance, ensuring documentation compliance, and supporting stability data submissions.

4) Procedure

4.1 Stability Study Design

1. Define stability study objectives, including study duration, testing intervals, and storage conditions (e.g., temperature, humidity).
2. Select appropriate stability-indicating methods and analytical techniques to monitor drug product stability and degradation pathways.
3. Prepare stability protocols outlining sample collection points, testing parameters, acceptance criteria, and statistical analysis plans.

4.2 Stability Sample Management

1. Prepare stability samples according to defined protocols, ensuring representative sampling from different batches and conditions.
2. Label