Monitoring Stability Studies in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for monitoring stability studies during the formulation development process, ensuring that stability conditions are maintained and data integrity is preserved.

2) Scope

This SOP applies to all formulation development projects within the organization, covering the monitoring of stability studies for new formulations, changes, or renewals.

3) Responsibilities

The responsibilities for this SOP include:
Formulation Development Team: Implementing and overseeing stability study protocols, including monitoring and data collection.
Quality Control: Monitoring stability conditions and conducting periodic testing of stability samples.
Quality Assurance: Reviewing stability study protocols and monitoring activities to ensure compliance with regulatory standards.
Regulatory Affairs: Supporting stability study monitoring and providing data for regulatory submissions.

4) Procedure

4.1 Study Initiation and Conditions

1. Initiate stability studies according to approved protocols, including setting up stability chambers or conditions as per study requirements.
2. Ensure stability chambers or storage conditions are qualified and maintained within specified temperature, humidity, and light conditions.
3. Label and organize stability samples for easy identification and retrieval during monitoring.

4.2 Sampling and Testing

1. Conduct scheduled sampling of stability samples at predefined intervals according to the stability protocol.
2. Perform testing on stability samples using validated analytical methods to