Capsule: SOP for Accelerated Stability Testing of Capsules – V 2.0

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Capsule: SOP for Accelerated Stability Testing of Capsules – V 2.0

Standard Operating Procedure for Accelerated Stability Testing of Capsules

Department Quality Control
SOP No. SOP/QC/212/2025
Supersedes SOP/QC/212/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to define the procedure for conducting accelerated stability testing on capsules to evaluate their stability under accelerated conditions. This testing helps predict the long-term shelf-life and potential degradation of capsules under accelerated environmental conditions.

2. Scope

This SOP applies to all accelerated stability tests conducted on capsules. It covers the setup, monitoring, and testing of capsules under accelerated storage conditions to assess their stability and degradation over time.

3. Responsibilities

  • Quality Control (QC) Team: Responsible for conducting accelerated stability testing, including the preparation, storage, and testing of capsules during the accelerated study period. The QC team will also document the results and ensure compliance with regulatory standards.
  • Regulatory Affairs Team: Ensures that the accelerated stability study protocol and results comply with regulatory requirements and guidelines.
  • Storage Facility Team: Ensures that the stability chambers are maintained under controlled conditions and that environmental parameters such as temperature, humidity, and light are regularly monitored.
  • Production Team: Provides the required batches of capsules for stability testing and ensures that the manufacturing processes comply with required standards.

4. Accountability

The Quality Control Manager is accountable for ensuring that the accelerated stability study is properly executed and that the data generated is accurate. The Regulatory Affairs Manager ensures compliance with regulatory guidelines. The Production Manager ensures that the required batches of capsules are provided and compliant with standards.

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5. Procedure

5.1 Pre-Study Preparation

Before initiating the accelerated stability study, ensure the following:

  1. Define Study Parameters

    1. Identify the capsules to be tested based on batch number, formulation, and anticipated shelf-life.
    2. Define the accelerated storage conditions, such as temperature (e.g., 40°C ± 2°C) and humidity (e.g., 75% RH), to accelerate degradation and mimic long-term storage conditions in a shorter timeframe.
    3. Set the time intervals for testing (e.g., 0, 3, 6, 9, 12 months).
  2. Prepare Stability Study Protocol

    1. Prepare and approve a stability study protocol, outlining the study design, test parameters, and sampling plan.
    2. Ensure the study protocol is aligned with ICH Q1A (R2) and other relevant regulatory guidelines for accelerated stability testing.
  3. Label and Identify Samples

    1. Label all stability samples clearly with product details, batch number, storage conditions, and the start date of the study.
  4. Prepare Environmental Conditions

    1. Ensure stability chambers are calibrated and set to the desired accelerated conditions for temperature and humidity.
    2. Monitor environmental conditions within the stability chambers to maintain the required parameters throughout the study period.

5.2 Conducting the Accelerated Stability Study

Follow these steps during the study:

  1. Store Samples Under Accelerated Conditions

    1. Place the samples in the stability chamber, maintaining the specified temperature and humidity conditions.
    2. Ensure that the samples are protected from external light and other environmental factors that may affect their stability.
  2. Monitor Environmental Conditions

    1. Continuously monitor and record the temperature and humidity inside the stability chamber to ensure that the conditions remain within the defined range.
    2. Adjust the environmental controls if necessary to maintain the required parameters.
  3. Periodic Sampling

    1. At each designated time point (e.g., 0, 3, 6, 9, 12 months), remove a sample of capsules from the stability chamber for testing.
    2. Ensure that the sampling is done in a controlled environment to prevent contamination or alteration of the samples.
  4. Conduct Testing on Samples

    1. Test the samples for relevant parameters such as potency, dissolution, disintegration, appearance, moisture content, and microbial contamination.
    2. Document the test results and any deviations from the expected outcomes.
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5.3 Data Analysis and Reporting

After completing the study, ensure the following:

  1. Evaluate Stability Data

    1. Analyze the stability data to assess the capsules’ degradation over time, focusing on changes in potency, dissolution, and other quality parameters.
    2. Compare the data with the acceptance criteria established in the stability study protocol to determine whether the capsules remain within specifications.
  2. Prepare Stability Report

    1. Prepare a detailed stability report summarizing the findings, including data analysis, conclusions, and shelf-life predictions.
    2. Include any recommendations based on the stability study outcomes, such as changes in storage conditions, packaging materials, or product formulations.
  3. Review and Approval

    1. Review the stability report for completeness and compliance with GMP and regulatory requirements.
    2. Ensure that the report is approved by the Quality Control Manager before submitting it for regulatory filing or product release decisions.

5.4 Post-Study Actions

After completing the accelerated stability study, ensure the following:

  1. Archive Study Data

    1. Archive all study data, including raw data, test results, and reports, according to the company’s data retention policy.
    2. Ensure that all records are stored in a secure and easily accessible manner for future reference and regulatory audits.
  2. Review Results for Product Release

    1. Review the accelerated stability data to assess the product’s viability for long-term storage and its projected shelf-life.
    2. Based on the results, determine whether the batch meets the required quality standards and is suitable for release.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • BPR: Batch Production Record
  • USP: United States Pharmacopeia
  • ICH: International Council for Harmonisation

7. Documents

  1. Annexure 1: Accelerated Stability Study Protocol
  2. Annexure 2: Stability Testing Data Record
  3. Annexure 3: Stability Study Report

8. References

  • ICH Q1A (R2) Stability Guidelines
  • USP <701> – Disintegration of Tablets and Capsules
  • Good Manufacturing Practice (GMP) 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: Accelerated Stability Study Protocol

Study ID Product Name Batch Number Start Date End Date Storage Conditions Sampling Timepoints
SS-002 Capsule B Batch 023 01/02/2025 01/08/2025 40°C, 75% RH 0, 3, 6, 9, 12 months

Annexure 2: Stability Testing Data Record

Batch ID Test Date Test Parameter Initial Value Final Value Deviation
Batch 023 07/02/2025 Potency 99% 98% None

Annexure 3: Stability Study Report

Batch ID Final Test Date Test Parameter Result Conclusions
Batch 023 01/08/2025 Potency 97% Approved for release

12. Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version of SOP Creation of SOP for accelerated stability testing QA Head
01/02/2025 2.0 Updated testing parameters and sampling intervals Inclusion of additional test parameters for better shelf-life prediction QA Head
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