Conducting Stability Testing for Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting stability testing during the formulation development process, ensuring that the formulated product maintains its quality, efficacy, and safety over time.

2) Scope

This SOP applies to all formulation development projects within the organization, covering the stability testing process from initial testing to final evaluation and documentation.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Overseeing the stability testing process and ensuring compliance with project timelines and objectives.
Formulation Scientists: Performing stability tests and monitoring product performance over time.
Quality Assurance: Reviewing and approving stability study protocols, data, and reports.

4) Procedure

4.1 Stability Study Design

1. Define the stability study objectives, including testing duration and conditions (e.g., temperature, humidity).
2. Develop a stability study protocol outlining testing parameters, sample collection points, and analytical methods.
3. Document the stability study design and protocol.

4.2 Sample Preparation

1. Prepare representative samples of the formulated product according to the stability study protocol.
2. Ensure samples are labeled accurately and stored under specified conditions.
3. Document sample preparation details and storage conditions.

4.3 Stability Testing

1. Conduct stability tests at defined intervals, following the established protocol.
2. Perform analytical testing (e.g., assay, impurity analysis, physical attributes) on stability samples.
3. Record all