SOP Guide for Pharma

SOP for Coordination Between Logistics and Warehouse Teams for Receipt of Raw Materials – V 2.0

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SOP for Coordination Between Logistics and Warehouse Teams for Receipt of Raw Materials – V 2.0

Standard Operating Procedure for Coordination Between Logistics and Warehouse Teams for Receipt of Raw Materials

Department Logistics / Warehouse / Quality Assurance / Procurement
SOP No. SOP/RM/047/2025
Supersedes SOP/RM/047/2022
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 coordination process between the Logistics and Warehouse teams to ensure the efficient, compliant, and accurate receipt of raw materials. This SOP ensures proper communication, handling, and documentation to maintain raw material quality and regulatory compliance.

2. Scope

This SOP applies to all raw materials delivered to the facility, including APIs, excipients, solvents, and packaging materials. It outlines procedures for material handover from Logistics to Warehouse, documentation requirements, and handling discrepancies.

3. Responsibilities

  • Logistics Team: Ensure timely delivery of raw materials, provide complete documentation, and communicate shipment details to Warehouse.
  • Warehouse Team: Verify material condition, cross-check documentation, and record receipt details.
  • Quality Assurance (QA): Review and approve receipt documentation, handle discrepancies, and ensure GMP compliance.
  • Procurement Department: Coordinate with suppliers and resolve discrepancies identified during receipt.
See also  SOP for Monitoring and Evaluating Supplier Performance in Raw Material Delivery - V 2.0

4. Accountability

The Logistics Manager is responsible for ensuring

timely and compliant transportation of materials. The Warehouse Manager is accountable for verifying and documenting the receipt of materials. The QA Manager holds authority for final approval, while the Procurement Manager ensures supplier coordination.

5. Procedure

5.1 Pre-Delivery Coordination

  1. Advance Shipment Notification: Logistics must notify the Warehouse team 24 hours before delivery, providing details such as:
    • Material name and batch number.
    • Estimated arrival time and transport conditions.
    • Shipping documentation (Bill of Lading, Certificate of Analysis, etc.).
  2. Pre-Delivery Checks: Warehouse confirms space availability, prepares for material inspection, and ensures all required equipment is ready.

5.2 Handover at Delivery

  1. Material Verification: Upon arrival, Warehouse verifies:
    • Material identity, batch number, and quantity against the delivery note.
    • Packaging integrity and compliance with specified transport conditions.
  2. Documentation Exchange: Logistics hands over the following documents to Warehouse:
    • Delivery Note and Bill of Lading.
    • Certificate of Analysis (CoA).
    • Temperature and Humidity Log (if applicable).

5.3 Post-Receipt Documentation and Review

  1. Warehouse Documentation: Warehouse logs receipt details in the Raw Material Receipt Log (Annexure-1) and submits documents to QA.
  2. QA Review: QA reviews the received documentation, verifies compliance, and approves or rejects materials. Discrepancies are documented in the Discrepancy Report (Annexure-2).
See also  SOP for Checking Compliance with Good Distribution Practices (GDP) at Receipt - V 2.0

5.4 Handling Discrepancies

  1. Identification of Discrepancies: Any differences in material quantity, identity, or condition are documented immediately.
  2. Resolution Process: The Warehouse notifies QA and Procurement of discrepancies. Procurement contacts the supplier for resolution. All actions are recorded in the Discrepancy Resolution Log (Annexure-3).

5.5 Final Material Disposition

  1. Approval or Rejection: QA approves compliant materials for storage and rejects non-compliant materials, documenting the final disposition in the Material Disposition Log (Annexure-4).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • CoA: Certificate of Analysis
  • PO: Purchase Order

7. Documents

  1. Raw Material Receipt Log (Annexure-1)
  2. Discrepancy Report (Annexure-2)
  3. Discrepancy Resolution Log (Annexure-3)
  4. Material Disposition Log (Annexure-4)

8. References

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

See also  SOP for Transporting Raw Materials from Receiving Area to Quarantine - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Receipt Log

Date Material Name Batch Number Quantity Received Transport Conditions Packaging Condition Received By
01/02/2025 API-X X-2025-001 100 kg 2-8°C Intact John Doe
02/02/2025 Excipient-Y Y-2025-002 200 kg Ambient Torn Packaging Jane Smith

Annexure-2: Discrepancy Report

Date Material Name Batch Number Discrepancy Observed Reported By Remarks
02/02/2025 Excipient-Y Y-2025-002 Torn Packaging Jane Smith Quarantined Pending QA Review

Annexure-3: Discrepancy Resolution Log

Date Discrepancy Description Resolution Action Responsible Department Status
03/02/2025 Torn Packaging on Excipient-Y Supplier Notified, Material Returned Procurement Closed

Annexure-4: Material Disposition Log

Date Material Name Batch Number Disposition Approved By Remarks
01/02/2025 API-X X-2025-001 Approved QA Manager Meets All Requirements
03/02/2025 Excipient-Y Y-2025-002 Rejected QA Manager Packaging Damage

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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