SOP for Checking Raw Material Shipment against Approved Purchase Order (PO) – V 2.0

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SOP for Checking Raw Material Shipment against Approved Purchase Order (PO) – V 2.0

Standard Operating Procedure for Checking Raw Material Shipment against Approved Purchase Order (PO)

Department Warehouse / Procurement / Quality Assurance
SOP No. SOP/RM/019/2025
Supersedes SOP/RM/019/2022
Page No. Page 1 of 14
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the method for verifying that incoming raw materials match the specifications and quantity stated in an approved Purchase Order (PO). Checking against the approved PO ensures that the correct material, batch number, and quantities are delivered, supporting accurate inventory management and upholding Good Manufacturing Practice (GMP) requirements. By following this SOP, the organization can minimize risks like receiving incorrect materials, incomplete shipments, or mislabeled products that could affect final product quality and regulatory compliance.

2. Scope

This SOP applies to all raw materials delivered to the facility’s warehouse or receiving dock. It covers:

  • Review of the Purchase Order (PO) and associated supplier documents (packing list, invoice, Certificate of Analysis if available).
  • Physical verification of the delivered materials (labeling, batch/lot numbers, packaging conditions) against the PO details.
  • Documentation of discrepancies and subsequent action, such as quarantine, rejection, or requesting additional shipments.

All Warehouse Personnel, Procurement staff, and Quality Assurance (QA) personnel must follow these steps to confirm alignment with GMP standards and internal quality protocols.

3. Responsibilities

  • Warehouse Personnel:

    • Compare the incoming shipment data (labels, delivery documents) with the PO specifications (item, batch number, quantity, etc.).
    • Document any discrepancies (e.g., shortages, incorrect batch numbers, damaged packaging) in the Raw Material Receiving Register (Annexure-1).
    • Segregate materials that do not match the PO in a designated quarantine area and notify QA and Procurement.
    • Update the inventory management system to reflect the verified or disputed receipt of goods.
  • Procurement Department:

    • Issue accurate POs to suppliers, ensuring the correct material name, batch requirements, and approved vendor details.
    • Address any discrepancies by liaising with the supplier to correct or replace wrong shipments or request partial shipments for short quantities.
    • Revise or update the PO if necessary and communicate changes to relevant departments (Warehouse, QA, Finance).
  • Quality Assurance (QA) Team:

    • Establish criteria for acceptable match between delivered materials and PO specifications, including any regulatory labeling requirements (batch, expiry, etc.).
    • Review and approve decisions on quarantining, rejecting, or releasing materials that do not conform to the PO details.
    • Oversee any deviations or non-conformance reports arising from PO mismatches or persistent supplier issues.

4. Accountability

The Warehouse Manager is responsible for implementing this SOP during receiving operations. The Procurement Manager ensures that the PO information is accurate and complete prior to shipment. QA holds final authority over acceptance or rejection of materials if they do not match the approved PO details or fail to meet GMP requirements. Any changes to this SOP must be approved by QA management to maintain regulatory compliance.

5. Procedure

5.1 Pre-Receipt Preparations

Proper planning ensures an organized receiving process, reducing the risk of missing or inaccurate data.

  1. Documentation Availability

    1. Procurement shares the final, approved PO (including revisions, if any) with the Warehouse. Confirm the PO details:
      • Material name and description
      • Quantity and packaging
      • Supplier details (name, address, shipping method)
      • Batch/lot requirements (if applicable)
      • Any specified labeling or safety instructions
    2. Have any supplementary documents (e.g., CoA, invoice, packing list) ready for cross-checking upon shipment arrival.
  2. Receiving Area Readiness

    1. Ensure the receiving area is clean, free of clutter, and that required equipment (pallet jacks, forklifts, scanners) is functional.
    2. Review the facility’s health and safety rules if handling hazardous or temperature-sensitive materials. Place signage or barricades as needed for specialized deliveries.
See also  SOP for Handling and Reporting Shortages in Raw Material Shipments - V 2.0

5.2 Unloading and Basic Inspection

Warehouse Personnel begin by verifying packaging and labeling conditions, noting any discrepancies.

  1. Offloading Process

    1. Unload each pallet or container carefully, ensuring no damage is caused during the offloading process. Organize them in a designated area for easy counting and label checks.
    2. If any packaging is visibly damaged or tampered with, mark those units for special inspection and notify QA. Document observations in the Raw Material Receiving Register (Annexure-1).
  2. Label Confirmation

    1. Check the container labels for essential information:
      • Material name (must match PO line item description)
      • Batch/lot number
      • Expiry or retest dates (if applicable)
      • Manufacturer details (if specified in the PO)
    2. Any container lacking a label or providing significantly different information from the PO (e.g., different batch) is segregated until QA approves further action.

5.3 Cross-Checking Against the PO

This step ensures that what was delivered matches both the quantity and the specifications outlined in the PO.

  1. Quantity Verification

    1. Count each container (drums, bags, boxes) and compare the total with the ordered quantity. Note any shortage or overage in the Raw Material Receiving Register.
    2. For partial shipments, ensure the PO allows multiple deliveries, or contact Procurement for clarification if partial deliveries were not arranged. Document the actual quantity received and label it “Partial Shipment” if more is expected.
  2. Specification Match

    1. If the PO requests a specific grade, particle size, or color, check the label or accompanying documents for these details. If the label is ambiguous or missing info, consult QA to decide if sampling or partial release is necessary.
    2. Verify that the batch number on the label aligns with any batch references in the PO or CoA. If the PO states a required batch and a different batch arrives, isolate that material until Procurement or QA instruct otherwise.
  3. Supplier Documentation

    1. Compare the supplier’s packing list or invoice with the PO. Ensure the line items match in material description, quantity, and price if indicated. Report discrepancies to Procurement for resolution.
    2. If a Certificate of Analysis (CoA) is included, confirm it references the correct batch number. If missing or incorrect, QA may require quarantine until the supplier provides a valid CoA.

5.4 Handling Discrepancies

Not all shipments arrive perfectly aligned with the PO. Mismatches must be documented and addressed promptly to prevent product quality risks.

  1. Minor Discrepancies

    1. A small quantity overage or shortage may be considered a minor discrepancy if within tolerance, subject to organizational policy. Procurement may choose to accept or request correction from the supplier, especially if production plans are unaffected.
    2. Record minor discrepancies in the receiving log. QA might not quarantine such items if quality and identity are verified. However, the final decision remains with QA.
  2. Major Discrepancies

    1. Significant shortages, incorrect materials, or missing essential labels (batch number, expiry date) warrant isolation of those containers in a designated quarantine area. Mark them with “Hold—PO Mismatch” or a similar label until QA reviews the situation.
    2. Initiate a deviation or non-conformance report if the mismatch could impact production schedules or pose a quality risk. Procurement must also engage the supplier for a corrective solution (e.g., supplemental shipment, replacement).
  3. Immediate QA Consultation

    1. If mislabeled or suspect materials arrive, QA determines whether additional testing, sampling, or documentation requests are needed. If the PO mismatch seems irreconcilable, QA can reject the shipment altogether.
    2. Procurement coordinates returns or disposal if QA rejects the delivery. Warehouse ensures the shipment remains segregated from approved stock until final disposition.
See also  SOP for Use of ‘Under Test’ Labels on Quarantined Materials - V 2.0

5.5 Update Records and Inventory Management Systems

Proper documentation ensures traceability and informs financial and production planning.

  1. Raw Material Receiving Register

    1. Complete or update the Raw Material Receiving Register (Annexure-1) with the shipment details: date, supplier name, material name, batch number, PO number, quantity, and any discrepancies noted.
    2. Include remarks like “Short by 5 kg,” “Incorrect Batch,” or “Over by 2 drums.” Sign or initial the entry for accountability. If an electronic system is used, ensure you finalize the log with a user ID or digital signature.
  2. Inventory Management System

    1. Enter the verified quantity into the inventory system, referencing the correct PO line item. If partial shipments or mismatches are found, label them accordingly.
    2. Attach or link the receiving documents, CoAs (if available), and any notes about discrepancies, so QA and Procurement have immediate access to the data.
  3. Cross-Department Communication

    1. Share final receiving results (quantities, batch details, any quarantine decisions) with Procurement and QA. Procurement will reconcile invoices, and QA will monitor quarantined or hold items until resolution.
    2. Keep a copy of or references to the shipping documents (packing list, invoice) along with the PO, either physically in the batch record or electronically in an ERP/WMS system.

5.6 Quarantine or Acceptance Decision

The final acceptance depends on QA’s review of the material’s compliance with the PO and initial inspections for quality concerns.

  1. QA Review

    1. QA cross-checks the Warehouse documentation and any test results (if preliminary sampling or ID checks were done). If the material is consistent with the PO specifications, QA may proceed with regular QC release testing or partial skip-lot testing.
    2. For items flagged as mismatched or suspect, QA instructs the Warehouse to keep them quarantined until further evaluation or supplier resolution. Deviations, rework, or return-to-vendor can follow based on QA’s conclusion.
  2. Acceptance and Storage

    1. Once QA is satisfied, Warehouse Personnel label the containers accordingly (e.g., “Approved—Pending Full QC Release” or direct them to standard quarantine). Update the inventory location and status in the system to avoid mixing unapproved stock with active inventory.
    2. After mandatory testing (if required by full QC procedures), QA issues final release, and the material is moved to its designated storage location for use in production.
  3. Rejection Process

    1. If QA confirms the material is unsuitable (e.g., severe labeling error, significant shortfall, or incorrect product), mark containers “Rejected.” Store them in a segregated reject area per GMP guidelines, preventing accidental use.
    2. Procurement contacts the supplier regarding replacements, credits, or disposal, referencing the PO mismatch. Document all decisions in the batch record and receiving logs.
See also  SOP for Labeling and Segregation of Raw Materials in Quarantine Area - V 2.0

5.7 Deviation Management and CAPA

Significant or repeated discrepancies between delivered goods and the approved PO may indicate supplier issues or internal process gaps requiring thorough investigation.

  1. Deviation or Non-Conformance Reports

    1. QA, in collaboration with Procurement and the Warehouse, opens a deviation report for major PO mismatches (e.g., entire wrong material, repeated significant shortages, or labeling errors). Attach supporting documents and pictures if applicable.
    2. Log the deviation in the quality management system, assigning a reference number for future audits and follow-ups.
  2. Root Cause Analysis

    1. Investigate whether the cause lies with the supplier (poor labeling practices, shipping errors) or internal processes (misreading the PO, inaccurate data entry). Procurement may engage the supplier to clarify confusion or propose corrective steps.
    2. Record any findings in the deviation report, highlighting the root cause and effect on material integrity or production schedules.
  3. Corrective and Preventive Actions (CAPA)

    1. Implement CAPA measures—such as updating PO templates for clarity, improving receiving checklists, or retraining staff to prevent future mismatches. Monitor their effectiveness over a defined period.
    2. Inform the supplier if the deviation reveals a supplier-side problem. Possible actions might include revising shipping labels, adjusting packaging protocols, or scheduling audits of their processes.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • CoA: Certificate of Analysis
  • SDS: Safety Data Sheet
  • CAPA: Corrective and Preventive Action
  • ERP: Enterprise Resource Planning
  • WMS: Warehouse Management System

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2), if testing is performed at receiving
  3. Purchase Orders, Supplier Packing Lists, and Invoices
  4. CoAs (if available), SDS
  5. Deviation / Non-Conformance Reports (if required)
  6. Supplier Communication Records (email, phone logs, etc.)

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 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  • Company-Specific Procurement, QA, and Warehouse Policies
  • Approved Vendor List (AVL) Documentation

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 Ordered Quantity Received Remarks
01/02/2025 ABC Pharma Supplies API A Lot-A123 PO-12345 100 kg 95 kg Short by 5 kg
02/02/2025 XYZ Chemical Distributors Excipient B Batch-B2025 PO-67890 500 kg 500 kg No Discrepancy

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result Remarks
01/02/2025 API A Lot-A123 John Doe Basic ID Test Pass N/A
02/02/2025 Excipient B Batch-B2025 Jane Smith Identification, pH Pending N/A

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 procedure for verifying incoming goods against PO
01/02/2025 2.0 Enhanced Steps Standardization of Document QA Head All All Added deeper guidelines on minor vs. major discrepancies and final acceptance criteria
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