Capsule: SOP for Sampling Protocols for Capsule Stability Testing – V 2.0

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Capsule: SOP for Sampling Protocols for Capsule Stability Testing – V 2.0

Standard Operating Procedure for Sampling Protocols for Capsule Stability Testing

Department Quality Control
SOP No. SOP/QC/215/2025
Supersedes SOP/QC/215/2022
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 sampling capsules during stability testing. This ensures representative samples are taken for testing at predefined intervals to assess the stability and quality of the capsules.

2. Scope

This SOP applies to all sampling activities conducted for stability testing of capsules. It outlines the sampling process, frequency, and criteria for testing at various time points during the stability study.

3. Responsibilities

  • Quality Control (QC) Team: Responsible for conducting the sampling process according to the specified protocol, ensuring that samples are representative of the batch, and documenting the results of testing at specified intervals.
  • Production Team: Provides the required batches of capsules for stability testing, ensuring proper labeling and batch identification.
  • Regulatory Affairs Team: Ensures that sampling procedures and protocols comply with regulatory guidelines for stability studies.
  • Storage Facility Team: Ensures that the stability samples are properly stored in the designated environmental conditions, as per the study protocol.

4. Accountability

The Quality Control Manager is responsible for overseeing the sampling process during stability studies, ensuring the samples are representative and meet all regulatory and quality requirements. The Regulatory Affairs Manager ensures compliance with stability study guidelines.

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5. Procedure

5.1 Pre-Sampling Setup

Before starting the sampling process, ensure the following:

  1. Review Study Protocol

    1. Review the stability study protocol to confirm the time intervals, sampling size, and criteria for sampling.
    2. Ensure that all parameters such as storage conditions, temperature, humidity, and light exposure are clearly defined.
  2. Prepare Sampling Materials

    1. Ensure all necessary equipment for sampling is clean and sterilized (e.g., gloves, sampling tools, containers).
    2. Label all containers properly to ensure proper identification of the samples, including batch number, time point, and storage conditions.
  3. Verify Environmental Conditions

    1. Verify that the stability chambers are operating within the required parameters (temperature, humidity, light exposure) for the study.
    2. Check the calibration and functioning of the environmental control systems before starting the sampling process.

5.2 Sampling Process

Follow these steps during the sampling process:

  1. Determine Sample Size

    1. Calculate the appropriate sample size based on the study protocol, considering factors like batch size and statistical requirements.
    2. Ensure that the sample size is large enough to represent the entire batch and allow for meaningful testing results.
  2. Sample Collection

    1. At each defined time point (e.g., 0, 3, 6, 9, and 12 months), collect the designated number of capsules from the stability chamber.
    2. Use clean and sterilized equipment for sampling to avoid contamination or alteration of the samples.
    3. Ensure that samples are evenly selected to represent the entire batch. If possible, sample from multiple locations within the batch.
  3. Record Sampling Information

    1. Record the date and time of sampling, the batch number, and any other relevant information such as the temperature and humidity of the stability chamber during the sampling process.
    2. Document the details of the sampling procedure in the stability study log, including the identities of the individuals involved in the sampling.
  4. Store Samples

    1. Immediately store the collected samples in the appropriate environmental conditions (e.g., room temperature, humidity-controlled areas) as per the study protocol.
    2. If required, ensure that samples are sealed and labeled for easy identification and retrieval for testing.
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5.3 Post-Sampling Testing

After completing the sampling, follow these steps:

  1. Conduct Laboratory Testing

    1. Perform the required tests on the samples, including potency, dissolution, disintegration, moisture content, and other relevant parameters specified in the study protocol.
    2. Ensure that the tests are performed in compliance with GMP and regulatory standards for stability testing.
  2. Document Test Results

    1. Record the results of all tests performed on the samples in the stability testing log, along with any deviations from expected values.
    2. Ensure that all data is verified for accuracy and completeness before being compiled into the final stability report.
  3. Analyze Stability Data

    1. Evaluate the stability data to determine if the capsules remain within specifications over the study period.
    2. Identify any trends in degradation, such as a loss in potency or dissolution rate, and evaluate whether they affect product quality.

5.4 Handling of Non-Conforming Samples

If any sample fails to meet the specifications during testing, ensure the following:

  1. Document Non-Conformity

    1. Document the failure in the non-conformance log, including the specific parameter that failed (e.g., potency, dissolution) and the batch number.
  2. Investigate Cause

    1. Investigate the root cause of the non-conformance, such as environmental factors, formulation issues, or manufacturing problems.
    2. Take corrective actions as necessary, including retesting, adjusting the formulation, or modifying the manufacturing process.
  3. Report to Regulatory Authorities

    1. If the failure is significant, report it to the relevant regulatory authorities and take any necessary steps to ensure continued compliance with the regulatory standards.
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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: Stability Sampling Log
  2. Annexure 2: Test Results Record
  3. Annexure 3: Non-Conformance Report

8. References

  • ICH Q1A – Stability Testing Guidelines
  • Good Manufacturing Practice (GMP) Guidelines
  • USP <701> – Disintegration of Tablets and Capsules

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Stability Sampling Log

Sample ID Batch Number Sampling Date Sampling Time Storage Conditions Remarks
SS-003 Batch 026 01/03/2025 10:00 AM 25°C, 60% RH Sampled from center of batch

Annexure 2: Test Results Record

Test Parameter Initial Value Final Value Test Date Remarks
Potency 100% 98% 07/03/2025 Acceptable range

Annexure 3: Non-Conformance Report

Deviation ID Batch Number Deviation Date Deviation Details Corrective Actions Resolved By
DEV-003 Batch 026 03/03/2025 Potency decrease of 2% Investigation ongoing, retesting in progress John Doe

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 sampling in stability testing QA Head
01/02/2025 2.0 Updated sampling intervals and documentation procedures Incorporated new regulatory guidelines QA Head
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