Evaluating Stability Data in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for evaluating stability data during the formulation development process, ensuring that data integrity is maintained and product stability characteristics are accurately assessed.

2) Scope

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

3) Responsibilities

The responsibilities for this SOP include:
Formulation Development Team: Evaluating stability data to assess product stability trends and degradation pathways.
Quality Control: Conducting statistical analysis and trending of stability data to determine shelf-life and storage conditions.
Quality Assurance: Reviewing stability data evaluation procedures and ensuring compliance with regulatory standards.
Regulatory Affairs: Using stability data to support regulatory submissions and product registration.

4) Procedure

4.1 Data Collection and Compilation

1. Collect stability data from ongoing stability studies, including results from periodic testing and environmental monitoring.
2. Compile stability data into organized datasets, ensuring completeness and accuracy of data entries.
3. Organize data by product batch, stability condition, and testing interval for systematic evaluation.

4.2 Data Analysis and Trending

1. Analyze stability data using statistical methods and software tools to identify trends and stability characteristics.
2. Perform trending analysis to monitor changes in product attributes over time and assess degradation pathways.
3. Generate graphical representations and summary reports of stability data trends for visualization and interpretation.

4.3 Shelf-life Determination

1. Calculate product shelf-life based on stability data analysis, considering degradation rates, storage conditions, and regulatory requirements.
2. Document shelf-life determinations and rationale, including supporting stability data and analytical findings.
3. Review and validate shelf-life calculations with cross-functional teams and regulatory affairs for approval.

4.4 Reporting and Recommendations

1. Prepare stability data evaluation reports summarizing findings, trends, and conclusions.
2. Include recommendations for product storage conditions, labeling requirements, and any necessary adjustments to stability protocols.
3. Review and approve stability data evaluation reports before submission to regulatory agencies and internal stakeholders.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Stability Data Sets
Statistical Analysis Reports
Shelf-life Determination Reports
Regulatory Submissions

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 Products

8) SOP Version

Version 1.0