SOP-005: Stability Testing Summary Report

1. Purpose

This document provides a standardized format for consolidating all stability test results into a single summary report. This summary supports shelf life determination and regulatory documentation requirements.

2. When to Complete

Complete this summary report when:

All planned stability studies have been completed
Determining final shelf life for product labeling
Preparing regulatory documentation
Reviewing batch for commercial release

3. Reference Documents

Attach or reference the following completed forms:

SOP-001: Real-Time Stability Record
SOP-002: Accelerated Stability Record
SOP-003: Freeze-Thaw Record
SOP-004: Centrifuge Test Record
PET/Challenge Testing Report (if applicable)
Microbial Screening Records (if applicable)

4. Shelf Life Determination Guidelines

Approved shelf life cannot exceed:

The last passing timepoint in real-time stability testing
Duration supported by PET/challenge testing results
Any manufacturer's recommended use-by date for key ingredients

Best Practice: Apply a safety margin (e.g., 90% of validated period) when determining commercial shelf life.

Stability Testing Summary Report

Product Information

Product Name:
Product Code/SKU:
Batch/Lot Number:
Manufacturing Date:
Formula Version:
Packaging Type:
Test Period:	From: __________ To: __________

Preservative System

Preservative(s) Used:
Concentration(s):
Initial pH:
Final pH:

Stability Test Results Summary

Test Type	Completed?	Result
Real-Time Stability	☐ Yes ☐ No	☐ Pass ☐ Fail
Accelerated Stability	☐ Yes ☐ No	☐ Pass ☐ Fail
Freeze-Thaw	☐ Yes ☐ No	☐ Pass ☐ Fail
Centrifuge	☐ Yes ☐ No	☐ Pass ☐ Fail
PET / Challenge Test	☐ Yes ☐ No	☐ Pass ☐ Fail
Microbial Screening	☐ Yes ☐ No	☐ Pass ☐ Fail

Conclusions

Overall Assessment:	☐ Stable ☐ Conditionally Stable ☐ Not Stable
Approved Shelf Life:	_______ months from date of manufacture
Storage Requirements:

Summary of Findings:

Recommendations / Follow-up Actions:

Approvals

Prepared By:		Date:
Reviewed By:		Date:
Approved By:		Date: