Standard Operating Procedure for Stability Data Management

1) Purpose

This SOP outlines the procedures for managing stability data generated from stability studies to ensure accurate documentation, analysis, and reporting of data to support product shelf life and regulatory submissions.

2) Scope

This SOP applies to all stability data generated from stability studies of pharmaceutical products, including drug substances and drug products, throughout their development and commercial lifecycle.

3) Responsibilities

The Stability Studies department or designated personnel are responsible for collecting, managing, and analyzing stability data. Quality Assurance (QA) and IT departments are responsible for ensuring data integrity and compliance with data management procedures.

4) Procedure

4.1 Data Collection

1. Collect stability data from stability studies at each predefined time point according to the stability protocol.
2. Ensure accurate and complete documentation of all test results, observations, and deviations.

4.2 Data Entry and Verification

1. Enter stability data into a designated database or electronic data management system.
2. Perform data verification to ensure accuracy and completeness of data entries.

4.3 Data Analysis

1. Analyze stability data to identify trends, outliers, and significant changes in product quality attributes.
2. Use statistical tools and software for data analysis and interpretation.

4.4 Data Reporting

1. Generate stability reports that summarize data, analysis, and conclusions regarding product stability and shelf life.
2. Review and approve stability reports to ensure compliance with regulatory requirements and internal quality standards.

4.5 Data Storage and Archiving

1. Store stability data in a secure and retrievable manner, either electronically or in physical archives.
2. Implement data retention policies to ensure data is maintained for the required regulatory and internal timeframes.

4.6 Data Integrity and Security

1. Ensure data integrity by implementing controls such as access restrictions, audit trails, and data backup procedures.
2. Regularly review and update data management procedures to comply with current regulatory requirements and best practices.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Stability Data Collection Forms, Data Entry Logs, Stability Reports, Data Archiving Records

7) Reference, if any

Regulatory guidelines such as FDA Guidance for Industry: Data Integrity and Compliance with Drug CGMP, EMA guidelines, ICH Q1E (Evaluation of Stability Data)

8) SOP Version

Version 1.0