Capsule: SOP for Reconciliation of Dispensed Materials – V 2.0

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Capsule: SOP for Reconciliation of Dispensed Materials – V 2.0

Standard Operating Procedure for Reconciliation of Dispensed Materials

Department Capsule Manufacturing
SOP No. SOP/CM/018/2025
Supersedes SOP/CM/018/2022
Page No. Page 1 of 7
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This SOP outlines the process for reconciling dispensed materials during capsule manufacturing to ensure that all materials are accounted for accurately and that discrepancies are promptly identified and addressed.

2. Scope

This SOP applies to all dispensing activities in capsule manufacturing, including the reconciliation of active pharmaceutical ingredients (APIs), excipients, and other materials used in the formulation of capsules.

3. Responsibilities

  • Manufacturing Personnel: Responsible for dispensing materials accurately, ensuring that materials are reconciled at each stage of the dispensing process, and reporting any discrepancies.
  • Quality Control (QC) Team: Responsible for reviewing the reconciliation records and ensuring that any discrepancies are addressed and documented properly.
  • Quality Assurance (QA) Team: Ensures compliance with this SOP and oversees the accuracy of the reconciliation process, providing corrective actions if necessary.
  • Warehouse Personnel: Responsible for ensuring that materials are received and stored accurately and that they are available for reconciliation when required.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring that all dispensing and reconciliation procedures are followed. The QA Manager is responsible for ensuring the accuracy of the reconciliation process and addressing discrepancies.

5. Procedure

5.1 Pre-Dispensing Reconciliation

Ensure proper reconciliation before dispensing any materials:

  1. Material Preparation

    1. Before dispensing, verify that the materials needed for the batch are correctly listed in the work order and batch record.
    2. Confirm that the correct batch of materials is selected, and ensure that the quantity required for dispensing matches the quantity specified in the batch record.
  2. Weighing and Documentation

    1. Weigh the required amount of each material using calibrated equipment and record the weight in the Material Dispensing Log (Annexure-1).
    2. Ensure that the dispensing is documented with the material name, batch number, quantity dispensed, and the operator’s name in the dispensing log.
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5.2 Dispensing Reconciliation

Ensure that materials are reconciled during and after the dispensing process:

  1. Scan and Record Materials

    1. Scan materials using barcode technology (if applicable) to ensure the correct material is being dispensed.
    2. Record the quantity dispensed into the system and check the information against the work order.
  2. Monitor Material Usage

    1. Track material usage in real-time to ensure that the correct quantities are being dispensed according to the batch record.
    2. Document any partial dispensing or excess usage in the Material Dispensing Log (Annexure-1).

5.3 Post-Dispensing Reconciliation

After dispensing, ensure that all materials are properly reconciled:

  1. Verify Dispensed Quantities

    1. Review the Material Dispensing Log and verify the quantity dispensed for each material against the planned quantity in the batch record.
    2. If there is a discrepancy in the quantity dispensed (e.g., excess or insufficient dispensing), stop the dispensing process and investigate the cause of the discrepancy.
  2. Document Discrepancies

    1. Document any discrepancies in the Discrepancy Report (Annexure-2), including the reason for the discrepancy and the corrective actions taken.
    2. Review the reconciliation results with the QA and QC teams to ensure that all materials are accounted for accurately.
  3. Finalize Reconciliation

    1. Once all discrepancies are resolved, finalize the reconciliation in the Material Dispensing Log (Annexure-1) and the batch record.
    2. Ensure that all documentation is signed by the dispensing operator and verified by the QA team.
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5.4 Corrective Actions for Discrepancies

If any discrepancies are identified during the reconciliation process, the following steps should be followed:

  1. Stop Dispensing Process

    1. If discrepancies are detected during dispensing, stop the process immediately to prevent further errors and to preserve the integrity of the batch.
  2. Investigate Discrepancies

    1. Conduct a thorough investigation to identify the root cause of the discrepancy, whether it was due to operator error, incorrect material labeling, equipment malfunction, or other factors.
  3. Implement Corrective Actions

    1. Implement corrective actions based on the findings of the investigation. This could include retraining personnel, recalibrating equipment, or adjusting procedures to prevent recurrence.
  4. Document Corrective Actions

    1. Record all corrective actions taken in the CAPA Log (Annexure-3) and ensure that they are reviewed and approved by the QA team.

5.5 Reconciliation of Materials After Batch Completion

Ensure that all materials are fully reconciled after the completion of each batch:

  1. Inventory Reconciliation

    1. After the batch is completed, perform a final reconciliation of all materials used during the batch manufacturing process.
    2. Verify that the remaining stock of materials matches the quantities recorded in the Material Dispensing Log and batch records.
  2. End-of-Batch Documentation

    1. Finalize all end-of-batch documentation, including the Material Dispensing Log (Annexure-1), and ensure that all records are completed and signed by the relevant personnel.
    2. Ensure that the batch records are complete and accurate, reflecting all materials dispensed, including those returned or discarded.

5.6 Record Retention

Ensure proper retention of all records related to material reconciliation:

  1. Document Retention

    1. Maintain all dispensing and reconciliation records for the required duration as per company policy and regulatory requirements.
    2. Ensure that records are stored securely and are easily accessible for audits, inspections, or quality reviews.
  2. Audit Trail

    1. Ensure that an audit trail is maintained for all reconciliation activities, including changes to material quantities, discrepancies, and corrective actions.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • CAPA: Corrective and Preventive Action
  • API: Active Pharmaceutical Ingredient

7. Documents

  1. Material Dispensing Log (Annexure-1)
  2. Discrepancy Report (Annexure-2)
  3. CAPA Log (Annexure-3)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal 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: Material Dispensing Log

Date Material Name Batch Number Quantity Dispensed Dispensed By
03/02/2025 Excipient-123 Batch 56789 200 g John Doe

Annexure-2: Discrepancy Report

Date Material Name Batch Number Issue Description Corrective Action
04/02/2025 API-456 Batch 12345 Excess dispensing Adjusted records and confirmed with QA

Annexure-3: CAPA Log

Date Issue Description Corrective Action Preventive Action
05/02/2025 Discrepancy in material dispensing Retrained personnel on dispensing procedures Implement regular checks and training

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 reconciliation procedures Standardization and clarity QA Head
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