for reviewing the results and approving the batch for release.

5. Procedure

5.1 Sample Collection

1. Collect a representative sample of tablets from the batch, as specified in the batch record.
2. The sample should consist of a predefined number of tablets (typically 6–12 tablets or as specified in the batch record or pharmacopeial guidelines).
3. Ensure that the tablets are free from defects such as cracks, chips, or contamination.
4. Label the sample appropriately for identification during testing.

5.2 Preparation of Controlled Testing Environment

1. Ensure that the controlled environment chambers (e.g., stability chambers, temperature-controlled rooms) are calibrated and maintained according to manufacturer specifications and company procedures.
2. Prepare the necessary environmental conditions, such as temperature (usually 25°C, 30°C, or 40°C), humidity (usually 60%, 75%, or 80%), and light exposure, based on the product’s specifications and regulatory requirements.
3. Ensure that the stability chamber is equipped with a data logging system to continuously monitor and record temperature, humidity, and light levels.

5.3 Conducting the Stability Test

1. Place the labeled tablet samples into the stability chamber, ensuring that the samples are placed in the proper position for even exposure to environmental conditions.
2. Run the stability test for the required duration, which may range from a few weeks to several months, depending on the specified testing protocol.
3. At regular intervals (e.g., 1, 3, 6, 12 months), remove the samples for testing and analysis. The number of intervals will depend on the stability testing plan defined for the batch.

5.4 Testing Parameters

1. During each testing interval, assess key physical and chemical properties, such as appearance, tablet hardness, disintegration time, dissolution, and assay of the active pharmaceutical ingredient (API).
2. Perform additional tests as required, such as microbiological testing or related substance testing, depending on the product’s requirements.
3. Record all test results and compare them to the initial results to determine if any degradation or change has occurred over time.

5.5 Data Recording and Calculation

1. Document all stability test results, including the test date, conditions (temperature, humidity, etc.), and all analytical data (e.g., dissolution profiles, assay results) in the batch record (Annexure-1).
2. Analyze the stability data to assess any trends or changes in the product’s performance. Ensure that the tablets meet the shelf-life specifications as defined in the batch record or pharmacopeial guidelines.
3. If the stability data indicates a failure to meet specifications, investigate and document the findings in the deviation report (Annexure-2).

5.6 Acceptance Criteria

1. Ensure that the tablets meet the stability requirements for shelf life, including the limits for dissolution, API content, and other relevant properties, at the end of the stability study period.
2. If any tablet sample fails the stability test, the batch must be investigated, and corrective actions should be documented.

5.7 Documentation and Record-Keeping

1. Document all stability test results, including observations, sample identification, environmental conditions, and analytical data, in the batch record (Annexure-1).
2. Maintain complete and accurate records of all stability tests for the required retention period in compliance with regulatory requirements.
3. Ensure all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.

5.8 Post-Test Cleanup

1. Ensure that the stability chamber is cleaned and maintained after each test cycle, following the manufacturer’s instructions and the company’s cleaning SOP.
2. Ensure all equipment used during the test is properly cleaned, calibrated, and stored for future use.

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

8. References

• USP <232> – Stability Testing of Drug Products
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Stability Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Sample Name	Test Date	Dissolution (%)	API Content (%)	Observation
Batch 001	Tablet Sample	12/01/2026	98%	100%	No significant change

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Dissolution rate lower than specification	Reformulated with adjusted excipient ratios	John Doe

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 Stability Testing Intervals	Improved test procedures and frequency	QA Head