SOP Guide for Pharma

Capsule: SOP for Production Reconciliation Reports for Capsules – V 2.0

Auditor

Capsule: SOP for Production Reconciliation Reports for Capsules – V 2.0

Standard Operating Procedure for Production Reconciliation Reports for Capsules

Department Capsule Manufacturing
SOP No. SOP/CM/093/2025
Supersedes SOP/CM/093/2022
Page No. Page 1 of 5
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to establish a standardized procedure for preparing and reviewing production reconciliation reports for capsules. These reports ensure that capsule production is accurately accounted for, identifying any discrepancies between raw materials used, production output, and finished products.

2. Scope

This SOP applies to all capsule production batches. It covers the creation, review, and approval of production reconciliation reports, which track the consumption of raw materials, production yields, and final product quantities.

3. Responsibilities

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that production reconciliation reports are accurately prepared and submitted for review. The QA Manager is responsible for reviewing the reports to ensure compliance with GMP guidelines and regulatory standards.

5. Procedure

5.1 Preparing the Production Reconciliation Report

Before preparing the reconciliation report, ensure the following steps are followed:

  1. Verify Production Details
    1. Ensure that all relevant production details are available, including the raw materials used, the production batch numbers, and the final quantity of capsules produced.
    2. Review the Batch Production Record (BPR) to ensure that all relevant data has been recorded, including capsule fill weights, coating quantities, and any adjustments made during production.
  2. Gather Raw Material Usage Data
    1. Obtain the raw material usage data, including the quantities of active pharmaceutical ingredients (APIs), excipients, and packaging materials used during production.
    2. Confirm that the quantities of raw materials match the quantities recorded in the Raw Material Usage Log (Annexure-1).
  3. Calculate Production Yields
    1. Calculate the expected yield based on the raw material quantities and the theoretical yield for the batch. Compare this with the actual output to identify any discrepancies.
    2. Ensure that the number of capsules produced matches the batch records and that any discrepancies are explained and documented.
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5.2 Documenting the Reconciliation Report

Once the necessary data has been gathered, complete the production reconciliation report:

  1. Fill in the Reconciliation Report Template
    1. Complete the production reconciliation report template (Annexure-2) with the required information, including the following:
      • Production batch number
      • Raw materials used (quantity and batch number)
      • Production yields (expected and actual)
      • Any discrepancies between raw material usage and final product yield
  2. Calculate the Discrepancies
    1. Compare the total amount of raw materials used with the expected consumption based on the product formula.
    2. If any discrepancies are identified, investigate the cause and document any corrective actions taken (e.g., material wastage, equipment malfunction, or human error).
  3. Complete the Report
    1. Ensure that all data is complete and accurate, and that the report includes all necessary signatures and approvals.
    2. Submit the completed report to the QA team for review and approval.
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5.3 Reviewing the Production Reconciliation Report

After the production reconciliation report is completed, the following steps should be taken for review:

  1. QC Review
    1. The QC team should review the report to ensure that the quantities of raw materials, production yields, and discrepancies are accurate and consistent with the batch records.
    2. If any discrepancies or concerns are identified, QC should investigate the issue and take corrective action as needed.
  2. QA Review
    1. The QA team should review the reconciliation report to ensure that it complies with GMP requirements and that any discrepancies are appropriately documented and addressed.
    2. QA should verify that the reconciliation report is signed off by the production team, QC, and any other relevant personnel.

5.4 Approving the Production Reconciliation Report

Once the review process is completed, the report should be approved as follows:

  1. Final Approval by QA
    1. QA should provide the final approval for the reconciliation report after reviewing the accuracy and completeness of the data.
    2. Ensure that any corrective actions taken in response to discrepancies are documented and completed before final approval.
  2. Document the Approval
    1. Document the approval process by having the QA Manager sign off on the report, confirming that the reconciliation is accurate and compliant with GMP guidelines.

5.5 Handling Discrepancies in Production Reconciliation

If discrepancies are identified during the reconciliation process, the following actions should be taken:

  1. Investigate the Discrepancy
    1. Investigate the root cause of the discrepancy, such as overuse of raw materials, equipment malfunction, or operator error.
  2. Implement Corrective Actions
    1. Implement corrective actions to address the cause of the discrepancy, such as re-calibrating equipment, retraining operators, or adjusting material handling processes.
  3. Document the Actions Taken
    1. Document all corrective actions and any changes made to prevent similar discrepancies in the future.
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5.6 Finalizing the Report

Once the reconciliation process is complete, finalize the report:

  1. Record Keeping
    1. Ensure that the production reconciliation report is properly filed and stored in accordance with company policies and regulatory requirements.
  2. Prepare for Audit
    1. Ensure that the report is available for internal or external audits as required by regulatory bodies or company policies.

6. Abbreviations

7. Documents

  1. Batch Production Record (BPR) (Annexure-1)
  2. Production Reconciliation Report (Annexure-2)
  3. Deviation Log (Annexure-3)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Production Record (BPR)

Batch ID Raw Material Used Quantity Used Expected Yield Actual Yield Discrepancies
Batch 001 API 500 kg 100,000 capsules 99,500 capsules 0.5% discrepancy

Annexure-2: Production Reconciliation Report

Batch ID Production Date Operator Name Quantity Produced Discrepancies Corrective Actions Taken
Batch 001 01/02/2025 John Doe 99,500 capsules 0.5% discrepancy Recalibrated equipment

Annexure-3: Deviation Log

Deviation ID Description Corrective Action Taken Operator Name Approval Status
DEV-001 Raw material overuse Adjusted material handling process Jane Smith Approved

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 reporting procedures and corrective actions Standardization QA Head
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