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 testing data and observations accurately.

4.4 Data Analysis and Interpretation

1. Analyze stability data to evaluate product stability trends and potential degradation pathways.
2. Interpret results to assess product shelf-life, storage conditions, and packaging suitability.
3. Document data analysis and interpretation in a stability study report.

4.5 Reporting and Documentation

1. Prepare comprehensive stability study reports summarizing test results, conclusions, and recommendations.
2. Include all raw data, analytical reports, and deviations encountered during the stability testing process.
3. Submit stability study reports for review and approval by senior management and quality assurance.

4.6 Ongoing Monitoring and Review

1. Monitor product stability beyond initial testing to confirm long-term stability profiles.
2. Conduct periodic reviews of stability data to identify any trends or changes requiring action.
3. Update stability protocols and reports as necessary based on ongoing data analysis and regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Stability Study Protocol
Stability Study Reports
Stability Testing Data
Analytical Test Results

7) Reference, if any

– ICH Q1A(R2): Stability Testing of New Drug Substances and Products
– FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products

8) SOP Version

Version 1.0