Developing Stability Protocols in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for developing stability protocols during the formulation development process, ensuring that stability studies are designed and conducted to support product quality and shelf-life determination.

2) Scope

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

3) Responsibilities

The responsibilities for this SOP include:
Formulation Development Team: Designing stability protocols based on product characteristics and regulatory requirements.
Quality Assurance: Reviewing and approving stability protocols to ensure compliance with regulatory standards.
Quality Control: Conducting stability studies and monitoring stability data throughout the study duration.
Regulatory Affairs: Ensuring stability protocols meet regulatory requirements and supporting submissions.

4) Procedure

4.1 Protocol Development

1. Define the objectives and scope of the stability study based on product characteristics, intended market, and regulatory requirements.
2. Identify critical stability parameters and study conditions (e.g., temperature, humidity) for the formulation.
3. Develop a detailed stability protocol outlining study design, sampling plan, and testing intervals.

4.2 Protocol Approval

1. Submit the stability protocol for review and approval by relevant stakeholders, including quality assurance and regulatory affairs.
2. Incorporate feedback and obtain final approval before initiating stability studies.
3. Ensure all changes