Capsule: SOP for Preparation of QC Reports for Capsule Testing – V 2.0

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Capsule: SOP for Preparation of QC Reports for Capsule Testing – V 2.0

Standard Operating Procedure for Preparation of QC Reports for Capsule Testing

Department Capsule Manufacturing
SOP No. SOP/CM/200/2025
Supersedes SOP/CM/200/2022
Page No. Page 1 of 8
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This SOP outlines the procedure for preparing the Quality Control (QC) reports for capsules, ensuring that all testing results, deviations, and corrective actions are documented and compliant with regulatory and quality standards.

2. Scope

This SOP applies to all QC testing activities for capsules at this facility. It covers the preparation, documentation, and reporting of results for all testing done during the capsule production process.

3. Responsibilities

  • Quality Control (QC) Team: Responsible for collecting testing data, compiling the QC reports, and ensuring all results are properly recorded.
  • Quality Assurance (QA) Team: Reviews and approves the QC reports for accuracy and compliance with regulatory standards.
  • Production Team: Ensures that all capsule testing is completed as per the schedule and that required samples are provided to QC.

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4. Accountability

The QA Manager is responsible for ensuring that the SOP is followed and that the reports comply with GMP and regulatory standards. The QC Supervisor is responsible for ensuring accurate data collection and report preparation.

5. Procedure

5.1 Pre-Report Preparation

Before preparing the QC report, ensure the following:

  1. Review Test Results

    1. Ensure that all required tests (e.g., hardness, disintegration, fill volume, etc.) have been completed and documented for the relevant batch of capsules.
  2. Ensure Data Completeness

    1. Check that all test data is complete and accurate. All sample results must be recorded, including any deviations or failures in the test procedures.
  3. Prepare Testing Equipment Logs

    1. Verify that equipment calibration logs and maintenance records for testing equipment are up to date.

5.2 Report Compilation

Follow these steps to compile the QC report:

  1. Document Test Data

    1. Document the results for all tests performed on the batch, including capsule weight, hardness, disintegration time, fill volume, etc. Include the acceptance criteria for each test.
  2. Identify Deviations

    1. If any test results deviate from the specified acceptance criteria, note the deviation and any corrective actions taken.
  3. Provide Conclusions

    1. State the conclusions regarding the quality of the batch based on the test results. If the batch passes all tests, state that the batch is approved for further processing. If there are any failures, state the corrective actions taken or required.
  4. Prepare Summary

    1. Provide a summary of the testing process, including the number of capsules tested, the testing methods used, and any issues encountered during testing.
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5.3 Post-Report Review

After the QC report is compiled, ensure the following:

  1. Review by QA

    1. The QA team reviews the QC report for accuracy, completeness, and compliance with regulatory requirements. Any discrepancies or issues should be resolved before final approval.
  2. Approval and Signature

    1. Once reviewed and approved, the QA team signs off on the report. The signed report is then stored for future reference.
  3. Distribution

    1. The final QC report is distributed to the appropriate departments (e.g., production, regulatory affairs) and stored in the relevant batch records.
  4. Record Keeping

    1. Ensure that all completed QC reports are properly filed and archived in accordance with GMP and regulatory guidelines for future reference or audits.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • EP: European Pharmacopoeia
  • USP: United States Pharmacopeia
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7. Documents

  1. Annexure 1: QC Test Data Log
  2. Annexure 2: Corrective Action Report
  3. Annexure 3: Batch Approval Form

8. References

  • USP <701> – Disintegration of Tablets and Capsules
  • European Pharmacopoeia 2.9.1 – Dissolution Testing
  • 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: QC Test Data Log

Batch ID Test Date Test Type Test Results Comments
Batch 014 02/02/2025 Hardness 8.2 N Pass

Annexure 2: Corrective Action Report

Batch ID Deviation Corrective Action Responsible Person Completion Date
Batch 014 Low fill volume Adjusted filling machine settings Production Supervisor 03/02/2025

Annexure 3: Batch Approval Form

Batch ID Approval Status Approved By Approval Date
Batch 014 Approved QA Manager 05/02/2025

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 QC reporting QA Head
01/02/2025 2.0 Updated report format and test procedures Improvement of reporting process QA Head
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