SOP Guide for Pharma

Tablets: SOP for Conducting Stability Testing in Controlled Environments – V 2.0

Auditor

Tablets: SOP for Conducting Stability Testing in Controlled Environments – V 2.0

Standard Operating Procedure for Conducting Stability Testing in Controlled Environments

Department Tablet
SOP No. SOP/TAB/087/2025
Supersedes SOP/TAB/087/2022
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 conducting stability testing of tablet products in controlled environments, ensuring that tablets meet the required shelf-life and performance characteristics over time under specified storage conditions.

2. Scope

This SOP applies to stability testing of tablets under controlled environmental conditions, including temperature, humidity, and light exposure, as specified by regulatory guidelines and internal stability testing protocols.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that stability testing is conducted in compliance with this SOP and for reporting the results. The QA Manager is responsible 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.
See also  Tablets: SOP for Visual Inspection of Tablet Coating Uniformity - V 2.0

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.
See also  Tablets: SOP for Physical Testing of Immediate Release Tablets - V 2.0

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.
See also  Tablets: SOP for Tablet Compression Force Monitoring and Adjustments - V 2.0

6. Abbreviations

7. Documents

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

8. References

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
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