Capsule: SOP for Stability Testing of Capsule Dosage Forms – V 2.0

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Capsule: SOP for Stability Testing of Capsule Dosage Forms – V 2.0

Standard Operating Procedure for Stability Testing of Capsule Dosage Forms

Department Capsule Manufacturing
SOP No. SOP/CM/192/2025
Supersedes SOP/CM/192/2022
Page No. Page 1 of 10
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This SOP outlines the procedure for conducting stability testing of capsule dosage forms to ensure that the capsules maintain their efficacy, safety, and quality under various environmental conditions throughout their shelf life.

2. Scope

This SOP applies to all capsule dosage forms subjected to stability testing to evaluate the impact of storage conditions on their physical, chemical, and microbiological properties.

3. Responsibilities

  • Quality Control (QC) Team: Responsible for performing stability testing, monitoring, and recording the results of capsules stored under different environmental conditions.
  • Quality Assurance (QA) Team: Ensures compliance with stability testing requirements and reviews the results to determine the product’s shelf life.
  • Regulatory Affairs Team: Ensures that the stability testing follows the applicable regulatory guidelines (e.g., ICH, WHO). The team is also responsible for maintaining records for regulatory submissions.

4. Accountability

The QA Manager is responsible for overseeing the stability testing program, ensuring adherence to regulatory standards. The QC Supervisor ensures proper execution of stability tests and documentation. The Regulatory Affairs Manager ensures compliance with regulatory guidelines and record-keeping.

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5. Procedure

5.1 Pre-Testing Setup

Before beginning the stability testing, ensure the following:

  1. Review Stability Testing Criteria

    1. Review the stability testing requirements based on the relevant regulatory guidelines (e.g., ICH Q1A, WHO guidelines). Ensure that the specifications for stability testing are approved by the QA department.
  2. Prepare Stability Testing Conditions

    1. Set up environmental chambers for storage of capsules under different temperature and humidity conditions (e.g., 25°C/60% RH, 30°C/65% RH, 40°C/75% RH, and accelerated conditions at 60°C/75% RH).
    2. Ensure that each chamber is calibrated and functioning properly to maintain the specified conditions.
  3. Prepare Sample Collection

    1. Collect a representative sample of capsules, typically 6 capsules per batch, for each storage condition. Ensure that the samples are randomly selected to represent the entire batch.

5.2 Stability Testing Procedure

Follow these steps to perform the stability testing:

  1. Place Capsules in Stability Chambers

    1. Place the capsule samples in the stability testing chambers, ensuring that they are properly labeled and stored under the correct conditions.
  2. Test the Capsules at Specified Time Intervals

    1. Take samples at predetermined time points (e.g., 0, 3, 6, 9, 12 months, or as per regulatory guidelines) and perform physical, chemical, and microbiological testing as per the protocol.
  3. Perform Physical Testing

    1. Perform visual inspections to assess any changes in appearance, such as discoloration, cracks, or deformation of the capsules.
    2. Measure and record capsule weight, dimensions, and hardness to detect any significant changes that may indicate instability.
  4. Perform Chemical Testing

    1. Test for any changes in the active pharmaceutical ingredient (API) concentration using appropriate analytical methods, such as high-performance liquid chromatography (HPLC).
    2. Check the dissolution profile of capsules to verify if the drug release characteristics are maintained under the stability conditions.
  5. Perform Microbiological Testing

    1. Conduct microbiological testing to check for any bacterial or fungal contamination that may have occurred during storage.
  6. Record and Review Results

    1. Document all test results and compare them with the acceptance criteria specified in the stability protocol.
    2. Any capsules that fail to meet the required specifications should be flagged for investigation, and corrective actions should be taken if necessary.
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5.3 Post-Testing Activities

After completing the stability tests, ensure the following:

  1. Review Results

    1. The QA Manager reviews all stability test results to determine whether the capsules meet the required stability criteria. If the capsules pass the test, they can be released for sale within the determined shelf life.
  2. Corrective Actions

    1. If any sample fails the stability testing, the issue should be investigated to identify the root cause (e.g., formulation issues, packaging problems). Corrective actions such as reformulation or packaging modifications should be implemented.
  3. Regulatory Reporting

    1. If required, report the stability testing results to the regulatory authorities, particularly in the case of accelerated testing or product registration applications.
  4. Record Keeping

    1. Ensure that all stability testing records, including raw data, test results, and corrective actions, are stored and archived in accordance with regulatory guidelines and internal policies.

6. Abbreviations

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

  1. Annexure 1: Equipment Calibration Log
  2. Annexure 2: Stability Testing Log
  3. Annexure 3: Corrective Action Report

8. References

  • USP <621> – Stability Testing of Drug Products
  • European Pharmacopoeia 5.1.3 – Stability Testing
  • International Council for Harmonisation (ICH) Q1A(R2) – Stability Testing of New Drug Substances and Products

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Equipment Calibration Log

Equipment ID Calibration Date Operator Calibration Details Next Calibration Due
Stability Chamber 110 01/02/2025 Jane Doe Calibration of temperature and humidity settings 01/02/2026

Annexure 2: Stability Testing Log

Capsule ID Test Date Temperature Condition Humidity Condition Test Result Comments
Batch 006 02/02/2025 25°C 60% RH Pass No issues

Annexure 3: Corrective Action Report

Batch ID Deviation Corrective Action Responsible Person Completion Date
Batch 006 Deviations in dissolution profile Adjustment in formulation and processing parameters Production Supervisor 03/02/2025

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 stability testing QA Head
01/02/2025 2.0 Updated testing conditions and log format Improvement of testing procedures and compliance QA Head
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