SOP for Receiving and Managing Multiple Batches of the Same Raw Material – V 2.0

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SOP for Receiving and Managing Multiple Batches of the Same Raw Material – V 2.0

Standard Operating Procedure for Receiving and Managing Multiple Batches of the Same Raw Material

Department Warehouse / Quality Assurance / Procurement / Quality Control
SOP No. SOP/RM/051/2025
Supersedes SOP/RM/051/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) defines the process for receiving, verifying, and managing multiple batches of the same raw material. It ensures proper identification, segregation, documentation, and compliance with Good Manufacturing Practices (GMP) to prevent mix-ups and maintain material integrity.

2. Scope

This SOP applies to all raw materials received in multiple batches under the same shipment or separate shipments. It includes procedures for receipt, inspection, sampling, documentation, and storage of Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other raw materials.

3. Responsibilities

  • Warehouse Personnel: Receive, inspect, and segregate multiple batches of raw materials. Ensure proper labeling and documentation.
  • Quality Assurance (QA): Review and approve documentation, ensure compliance with GMP standards, and authorize material release.
  • Quality Control (QC): Perform sampling and testing of each batch for compliance with specifications.
  • Procurement Department: Ensure suppliers provide batch-specific documentation and resolve discrepancies.

4. Accountability

The

Warehouse Manager is responsible for the accurate receipt and segregation of multiple batches. The QA Manager holds authority to approve or reject materials based on compliance. The QC Manager ensures that each batch meets the required specifications, while the Procurement Manager ensures the completeness and accuracy of supplier documentation.

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5. Procedure

5.1 Pre-Receipt Preparations

  1. Supplier Documentation:

    • Procurement ensures that suppliers provide individual Certificates of Analysis (CoA) and batch-specific documentation for each batch.
    • Logistics informs the Warehouse and QA teams about the expected arrival of multiple batches, including batch numbers and quantities.
  2. Pre-Delivery Coordination:

    • Warehouse prepares for receipt by ensuring designated storage areas are available for batch segregation.

5.2 Receiving and Inspecting Multiple Batches

  1. Initial Material Verification:

    • Warehouse personnel verify:
      • Material identity, batch numbers, and quantities against the delivery note.
      • Packaging integrity and proper labeling of each batch.
    • Document receipt details in the Multiple Batch Receipt Log (Annexure-1).
  2. Segregation of Batches:

    • Physically segregate each batch in the quarantine area to prevent cross-contamination.
    • Label each batch with “UNDER TEST” status, batch number, and other relevant information.

5.3 Sampling and Testing of Multiple Batches

  1. Sampling Procedure:

    • QC personnel perform sampling for each batch separately following standard sampling procedures.
    • Document sampling details in the Batch Sampling Log (Annexure-2).
  2. Testing and Compliance:

    • Conduct required tests for each batch to ensure compliance with specifications.
    • Record test results in the Batch Test Report (Annexure-3).
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5.4 Approval and Material Disposition

  1. QA Review and Approval:

    • QA reviews the test reports and documentation for each batch.
    • Approve compliant batches for release to the storage area and reject non-compliant batches, documenting in the Batch Disposition Log (Annexure-4).

5.5 Handling Discrepancies

  1. Identification and Documentation:

    • Any discrepancies in batch numbers, quantities, or documentation are recorded in the Discrepancy Report (Annexure-5).
    • Warehouse notifies QA and Procurement to resolve discrepancies.
  2. Corrective Actions:

    • Procurement contacts the supplier for clarification or resolution.
    • QA ensures corrective actions are implemented before final approval or rejection.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • API: Active Pharmaceutical Ingredient
  • QA: Quality Assurance
  • QC: Quality Control
  • CoA: Certificate of Analysis

7. Documents

  1. Multiple Batch Receipt Log (Annexure-1)
  2. Batch Sampling Log (Annexure-2)
  3. Batch Test Report (Annexure-3)
  4. Batch Disposition Log (Annexure-4)
  5. Discrepancy Report (Annexure-5)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

See also  SOP for Storing Excipients Based on Pharmacopoeial Guidelines - V 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Multiple Batch Receipt Log

Date Material Name Batch Number Quantity Received Packaging Condition Received By
01/02/2025 API-X X-2025-001 100 kg Intact John Doe
01/02/2025 API-X X-2025-002 150 kg Intact Jane Smith

Annexure-2: Batch Sampling Log

Date Material Name Batch Number Sample ID Sampled By Remarks
02/02/2025 API-X X-2025-001 SAMP-001 Mark Lee Sent to QC
02/02/2025 API-X X-2025-002 SAMP-002 Anna White Sent to QC

Annexure-3: Batch Test Report

Date Material Name Batch Number Test Performed Result Conclusion
03/02/2025 API-X X-2025-001 Purity Test Pass Approved
03/02/2025 API-X X-2025-002 Purity Test Pass Approved

Annexure-4: Batch Disposition Log

Date Material Name Batch Number Disposition Approved By Remarks
04/02/2025 API-X X-2025-001 Approved QA Manager Meets Specifications
04/02/2025 API-X X-2025-002 Approved QA Manager Meets Specifications

Annexure-5: Discrepancy Report

Date Material Name Batch Number Discrepancy Reported By Corrective Action Status
02/02/2025 API-X X-2025-002 Incorrect Labeling John Doe Supplier Notified, Label Corrected Closed

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
01/02/2025 2.0 Added Discrepancy Handling Procedures Standardization QA Head
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