Standard Operating Procedure for Shelf-Life Stability Testing in Accelerated Conditions

Department	Quality Control
SOP No.	SOP/TAB/116/2025
Supersedes	SOP/TAB/116/2022
Page No.	Page 1 of 7
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for performing shelf-life stability testing under accelerated conditions to assess the stability of tablet formulations over time and predict their shelf-life.

2. Scope

This SOP applies to the shelf-life stability testing of tablet formulations under accelerated conditions, typically involving high temperature and humidity to accelerate the aging process, for the purpose of predicting the product’s expiration date and ensuring quality throughout the product’s life cycle.

3. Responsibilities

• Quality Control (QC): Responsible for performing stability testing under accelerated conditions, monitoring the stability indicators, and ensuring that results meet specifications.
• Quality Assurance (QA): Ensures that stability testing is conducted following this SOP and reviews the results to ensure compliance with regulatory requirements.
• Laboratory Personnel: Responsible for preparing samples, setting up stability testing conditions, and recording results accurately.

4. Accountability

The QC Manager is accountable for ensuring that accelerated stability testing is performed accurately and in compliance with the company’s stability testing protocol. The QA Manager is responsible for reviewing and approving the test results to ensure regulatory compliance and reliability of the data.

5. Procedure

5.1 Sample Preparation

1. Select a representative batch of tablets for testing, ensuring that the sample is representative of the batch’s quality.
2. Prepare the tablets according to the standard procedure for testing, ensuring they are free from any contaminants or foreign substances.
3. For stability testing, typically use a sufficient number of tablets (e.g., 100 tablets per sample) to ensure statistical reliability.

5.2 Setting Accelerated Testing Conditions

1. Place the prepared samples in appropriate packaging and store them in accelerated conditions, typically involving:
   • Temperature: 40°C ± 2°C
   • Relative Humidity: 75% ± 5%
2. Ensure that the testing conditions mimic extreme environments likely to affect tablet stability over time.
3. Record the environmental conditions continuously using a data logger to ensure stability of the testing environment.

5.3 Testing Intervals

1. Perform tests at regular intervals throughout the accelerated stability period, typically at 0, 1, 2, 3, 6, and 12 months.
2. Record and monitor the following parameters during each test interval:
   • Appearance and color of the tablets
   • API content (via HPLC or appropriate method)
   • Disintegration time
   • Dissolution profile
   • Moisture content (if applicable)

5.4 Data Analysis and Interpretation

1. Compare the data collected at each interval to the initial data for the batch (0 months) to detect any significant changes or degradation in tablet properties.
2. Calculate the degradation rate and predict the shelf life based on the stability data, using the Arrhenius equation or similar methods for accelerated stability testing.
3. Document all observations, including any deviation from expected results, and provide an assessment of the product’s stability.

5.5 Acceptance Criteria

1. The tablets should meet the following criteria:
   • No significant change in appearance or color.
   • API content remains within the defined acceptable limits (e.g., ±10% of initial content).
   • Disintegration and dissolution rates remain consistent with the specifications.
   • Moisture content does not exceed the defined limits.
2. If any of these criteria are not met, initiate an investigation and document corrective actions in the deviation report (Annexure-1).

5.6 Documentation and Record-Keeping

1. Document all stability test results, including environmental conditions, test results, observations, and data analysis, in the batch record (Annexure-2).
2. Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
3. Maintain raw data, including chromatograms, dissolution profiles, and any deviation reports, for regulatory compliance and future reference.

5.7 Post-Test Actions

1. Clean and calibrate any equipment used for testing, such as dissolution apparatus and HPLC systems, to maintain accuracy and reliability for future tests.
2. Dispose of used samples, solvents, and reagents according to the company’s waste disposal procedures.
3. Ensure that all testing equipment is maintained and calibrated according to the manufacturer’s instructions and company SOPs.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient
• HPLC: High-Performance Liquid Chromatography

7. Documents

1. Batch Record (Annexure-2)
2. Deviation Report (Annexure-1)

8. References

• USP <1151> – Stability Testing
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Stability Testing Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	API degradation observed in accelerated testing	Reformulated batch and re-tested	John Doe

Annexure-2: Batch Record

Batch Number	Test Interval (Months)	API Content (%)	Disintegration Time (min)	Dissolution Profile	Result
Batch 001	0	100%	5 min	Pass	Pass

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated testing intervals	Improved shelf-life prediction	QA Head