SOP for Coordination with Procurement Department During Raw Material Receipt – V 2.0

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SOP for Coordination with Procurement Department During Raw Material Receipt – V 2.0

Standard Operating Procedure for Coordination with Procurement Department During Raw Material Receipt

Department Warehouse / Quality Assurance / Quality Control / Procurement
SOP No. SOP/RM/036/2025
Supersedes SOP/RM/036/2022
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) outlines the process for effective coordination between the Procurement Department and the Warehouse, Quality Assurance (QA), and Quality Control (QC) teams during the receipt of raw materials. Clear communication and collaboration between these departments ensure that raw materials are received, inspected, and documented accurately, in compliance with Good Manufacturing Practices (GMP) and regulatory requirements. This SOP aims to:

  • Ensure timely and accurate receipt of raw materials as per purchase orders and supplier agreements.
  • Facilitate proper verification of supplier documentation, material specifications, and regulatory compliance.
  • Address discrepancies, damages, or deviations during material receipt promptly and effectively.
  • Maintain transparency and accountability in the raw material supply chain.

2. Scope

This SOP applies to all raw materials received at the facility, covering coordination activities between the Procurement Department and the Warehouse, QA, and QC teams. It includes:

  • Communication protocols for raw material orders, shipment tracking, and receipt verification.
  • Processes for handling discrepancies, damaged goods, or incomplete documentation during receipt.
  • Documentation and record-keeping responsibilities for all departments involved in the material receipt process.
  • Supplier communication and corrective action management for issues identified during receipt.

3. Responsibilities

  • Procurement Department:

    • Place orders with suppliers and ensure that purchase orders (POs) reflect accurate material specifications, quantities, and delivery requirements.
    • Provide the Warehouse with POs, invoices, Certificates of Analysis (CoAs), and any other relevant supplier documentation before the arrival of materials.
    • Coordinate with suppliers to address shipment delays, discrepancies, or non-compliance issues.
    • Maintain communication with QA and QC teams regarding supplier performance and material compliance.
  • Warehouse Personnel:

    • Receive and inspect raw materials based on POs and supplier documentation provided by the Procurement Department.
    • Communicate any discrepancies, damages, or missing documentation to the Procurement Department and QA immediately.
    • Record all material receipt details in the Raw Material Receiving Register (Annexure-1) and maintain proper documentation.
  • Quality Assurance (QA) Team:

    • Review supplier documentation for compliance with GMP and regulatory requirements.
    • Approve or reject materials based on inspection findings and documentation verification.
    • Coordinate with Procurement for corrective actions related to supplier performance or material compliance issues.
  • Quality Control (QC) Team:

    • Conduct sampling and testing of raw materials as per standard procedures.
    • Report any deviations or non-conformances to QA and coordinate with Procurement for corrective actions if supplier issues are identified.
See also  SOP for Handling Suspected Counterfeit or Adulterated Raw Materials - V 2.0

4. Accountability

The Procurement Manager is responsible for ensuring that all supplier documentation is accurate and provided to the Warehouse and QA teams in a timely manner. The Warehouse Manager is accountable for verifying that received materials match purchase orders and supplier documentation. The QA Manager holds the authority to approve, quarantine, or reject materials based on compliance with supplier requirements and regulatory standards.

5. Procedure

5.1 Pre-Receipt Coordination

  1. Order Placement and Supplier Communication

    1. Procurement places orders with suppliers, ensuring that POs clearly specify:
      • Material names, grades, and specifications.
      • Batch numbers, quantities, and packaging requirements.
      • Special handling instructions, if applicable (e.g., temperature control, hazardous material protocols).
    2. Procurement obtains shipment details, including expected delivery dates, shipping methods, and tracking information.
  2. Provision of Supplier Documentation

    1. Procurement provides the Warehouse and QA with the following documents before material arrival:
      • Purchase Orders (POs).
      • Invoices and packing lists.
      • Certificates of Analysis (CoAs) and Material Safety Data Sheets (MSDS), if applicable.
      • Any regulatory certificates or supplier compliance documents.
    2. Ensure that all documentation is complete, accurate, and matches the PO details.
See also  SOP for Labeling and Segregation of Raw Materials in Quarantine Area - V 2.0

5.2 Material Receipt and Inspection

  1. Verification of Received Materials

    1. Warehouse personnel receive and unload materials, verifying that:
      • Received quantities match the PO and packing list.
      • Material names, batch numbers, and packaging specifications align with supplier documentation.
      • No physical damage, leakage, or discrepancies are observed.
    2. Record all receipt details in the Raw Material Receiving Register (Annexure-1).
  2. Handling Discrepancies and Missing Documentation

    1. If discrepancies (e.g., incorrect quantities, damaged packaging) or missing documentation are identified:
      • Warehouse personnel immediately inform the Procurement Department and QA.
      • Procurement contacts the supplier to resolve the issue and provides updates to the Warehouse and QA teams.
      • QA may quarantine materials until discrepancies are resolved and documentation is verified.

5.3 Documentation and Record-Keeping

  1. Recording and Filing Documentation

    1. Warehouse personnel ensure that all receipt details are accurately recorded in the Raw Material Receiving Register.
    2. QA reviews supplier documentation for completeness and compliance, then files it in the raw material documentation archive.
    3. Procurement maintains electronic records of POs, supplier correspondence, and corrective action reports for audit purposes.
  2. Managing Non-Conformances and Corrective Actions

    1. QA logs any non-conformances related to material receipt and coordinates with Procurement to implement corrective actions.
    2. Procurement communicates corrective actions to suppliers and ensures that future shipments meet compliance requirements.

5.4 Supplier Performance Monitoring

  1. Evaluation of Supplier Compliance

    1. Procurement, QA, and Warehouse teams collaborate to evaluate supplier performance based on:
      • Accuracy and completeness of supplied materials and documentation.
      • Timeliness and reliability of deliveries.
      • Compliance with regulatory and GMP requirements.
    2. Document supplier evaluations and use them to inform future procurement decisions.
  2. Addressing Persistent Supplier Issues

    1. If persistent issues with a supplier are identified (e.g., repeated discrepancies, delays, or non-compliance):
      • Procurement escalates the issue to management for review and potential supplier disqualification.
      • QA documents the supplier’s performance in the non-conformance log for future reference.
See also  SOP for Inspection of Incoming Raw Materials Packaging - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • MSDS: Material Safety Data Sheet
  • CoA: Certificate of Analysis

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2)
  3. Purchase Orders (POs) and Supplier Invoices
  4. Certificates of Analysis (CoAs) and Material Safety Data Sheets (MSDS)
  5. Non-Conformance Reports and Corrective Action Logs

8. References

  • 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
  • ICH Q7 – GMP for Active Pharmaceutical Ingredients
  • Company-Specific Procurement, QA, and Warehouse Policies

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 Receiving Register

Date Supplier Name Material Name Batch Number PO Number Quantity Inspection Findings Remarks
01/02/2025 ABC Chemicals API-X X-2025-001 PO-12345 100 kg Packaging Intact, Documentation Verified Accepted
02/02/2025 XYZ Pharma Excipient-Y Y-2025-002 PO-67890 200 kg Missing CoA, Incorrect Labeling Quarantined, Pending Supplier Update

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result Remarks
01/02/2025 API-X X-2025-001 John Doe Identity Test Pass Approved for Use
03/02/2025 Excipient-Y Y-2025-002 Jane Smith Purity Test Pending Awaiting Documentation Verification

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By Page No. Ref. Point No. Details of Revision
01/01/2024 1.0 Initial Version New SOP Creation QA Head All All Established procedures for coordination between Procurement and Warehouse during raw material receipt.
01/02/2025 2.0 Enhanced Supplier Communication Protocols Standardization of Document QA Head All All Added detailed steps for handling discrepancies and improving supplier performance monitoring.
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