Documentation and Reporting of Stability Study Test Results

Purpose

The purpose of this Standard Operating Procedure (SOP) is to describe the process for documenting and reporting the test results of stability studies. This ensures that the data is accurately recorded, analyzed, and communicated in a standardized format for regulatory compliance and decision-making.

Scope

This SOP applies to all stability studies conducted within the facility, covering all types of drug products and their respective test results.

Responsibilities

• Stability Manager: Oversee the documentation and reporting process, ensuring accuracy and compliance with regulatory standards.
• Stability Technicians: Perform testing, document results, and assist in the preparation of reports.
• Quality Assurance (QA) Team: Review and approve the test results and final reports for accuracy and compliance.

Procedure

1. Data Recording:
   • Document all test results immediately after testing in the appropriate laboratory notebooks or electronic systems.
   • Ensure that all entries are clear, accurate, and complete, including date, time, and analyst’s initials.
   • Use appropriate units of measurement and follow standard nomenclature
     

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     for all entries.
2. Data Verification:
   • Verify the recorded data for accuracy and completeness before proceeding to data analysis.
   • QA personnel should cross-check the data entries against raw data and test protocols.
   • Document any discrepancies and resolve them promptly before finalizing the data.
3. Data Analysis:
   • Analyze the test results according to the predefined statistical methods and stability protocols.
   • Generate summary tables, graphs, and charts to illustrate the stability trends over time.
   • Interpret the results to assess whether the product meets the stability criteria and specifications.
4. Report Preparation:
   • Prepare a comprehensive stability study report that includes:
     • Introduction and purpose of the study
     • Materials and methods, including test procedures and conditions
     • Results, including raw data, summary tables, graphs, and charts
     • Discussion of results and their implications
     • Conclusions and recommendations
     • Appendices with supporting documents, if applicable
   • Ensure that the report is clear, concise, and follows the facility’s standard format and guidelines.
5. Report Review and Approval:
   • Submit the draft report to the Stability Manager for initial review and feedback.
   • Make necessary revisions based on feedback and resubmit for final review.
   • QA Team to review the final report for accuracy, completeness, and compliance with regulatory requirements.
   • Obtain approval signatures from the Stability Manager and QA Team before finalizing the report.
6. Report Distribution:
   • Distribute the approved stability study report to relevant stakeholders, including regulatory affairs, product development, and quality control departments.
   • Ensure that electronic copies are saved in the facility’s document management system and hard copies are filed in the stability study records.

Abbreviations Used

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Stability Protocol
• Laboratory Notebooks/Electronic Data Systems
• Summary Tables and Graphs
• Stability Study Reports
• Audit Reports

References

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

SOP Version

Version 1.0 – Effective Date: [Insert Date]