SOP for Receiving of Raw Materials from Vendors – V 2.0

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SOP for Receiving of Raw Materials from Vendors – V 2.0

Standard Operating Procedure for Receiving of Raw Materials from Vendors

Department Supply Chain / Warehouse
SOP No. SOP/RM/001/2025
Supersedes SOP/RM/001/2022
Page No. Page 1 of 12
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a consistent, GMP-compliant method for receiving raw materials from vendors. Ensuring that each received shipment meets quality, safety, and documentation requirements is critical to maintaining product integrity and compliance with regulatory standards. This SOP aims to minimize risks associated with contaminated, counterfeit, or misdelivered materials and to streamline the intake process for more efficient inventory management.

2. Scope

This SOP applies to all raw materials received at our facility’s loading and receiving docks. It encompasses preliminary verification, documentation review, visual inspection, quarantine, and release procedures, as well as the responsibilities of personnel involved in receiving, quality control, and quality assurance. This SOP should be followed by Warehouse, Quality Control (QC), Quality Assurance (QA), Procurement, and any other relevant departments involved in the supply chain process.

3. Responsibilities

  • Warehouse Personnel:
    • Offload received materials safely and efficiently.
    • Conduct initial checks, such as verifying packaging integrity and labeling.
    • Place materials into designated quarantine or receiving areas.
    • Record essential information (such as delivery date, vendor name, and Purchase Order) in the Raw Material Receiving Register.
  • Quality Control (QC) Team:
    • Perform visual inspection upon request if specialized checks are needed.
    • Conduct sampling and testing as per set specifications.
    • Review and verify documents such as Certificate of Analysis (CoA) and Safety Data Sheets (SDS).
  • Quality Assurance (QA) Team:
    • Oversee compliance with this SOP and relevant GMP regulations.
    • Ensure all materials meet internal and regulatory standards before release.
    • Review and approve any deviations or non-conformances that arise during receiving.
  • Procurement Department:
    • Generate accurate Purchase Orders (POs) with approved vendors.
    • Coordinate with vendors to ensure complete and accurate shipping documents.
    • Work with QA/QC to maintain an updated Approved Vendor List (AVL).
  • Safety and Compliance Officers (if applicable):
    • Oversee the safe handling and storage of materials, especially if hazardous.
    • Provide up-to-date safety protocols for handling chemicals or high-risk materials.

4. Accountability

The Head of Supply Chain (or an equivalent authorized person) is accountable for ensuring the correct implementation of this SOP across the receiving operations. Final accountability rests with the Quality Assurance (QA) Manager or Head, who must approve any changes or revisions to this document to maintain compliance with regulatory standards.

5. Procedure

5.1 Receiving Raw Materials

The following steps outline the initial receiving process for raw materials arriving at the facility from approved vendors.

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

  1. Pre-Delivery Coordination

    1. The Procurement Department communicates expected delivery dates and times to the Warehouse team.
    2. Warehouse Personnel prepare the receiving area, ensuring it is clean, well-lit, and free of obstructions or leftover materials.
    3. Check that calibrated equipment (e.g., weighing scales, temperature monitors) is functional and accessible.
  2. Unloading Process

    1. Upon arrival, review transport documentation (delivery note, packing list) for consistency with the Purchase Order.
    2. Ensure safe offloading practices, using forklifts or pallet jacks where required.
    3. Visually inspect the truck interior for any spillage, leakage, or contamination before unloading.
    4. Segregate any visibly damaged or non-conforming shipment in a designated holding area.
  3. Initial Document Check

    1. Match the number of packages/containers received with the quantity indicated on the delivery note and PO.
    2. Identify any discrepancies, and communicate them immediately to Procurement and QA for resolution.
    3. Record basic information—such as date of receipt, vendor name, quantity of materials, and PO number—in the Raw Material Receiving Register (refer to Annexure-1).

5.2 Visual Inspection and Documentation Verification

This step is crucial to identify obvious defects and ensure the shipment arrives with correct paperwork.

  1. Package Inspection

    1. Examine every container for visible damage (tears, dents, punctures, or signs of tampering).
    2. Confirm that each container’s seal is intact; broken seals must be reported to QA for potential investigation.
    3. Check labeling for correct material name, batch/lot number, vendor details, and regulatory markings.
  2. Documentation Verification

    1. Review the Certificate of Analysis (CoA), Safety Data Sheet (SDS), and any additional technical data sheets provided by the vendor.
    2. Ensure that the CoA is valid, references the correct batch or lot number, and lists the key specifications and test results required.
    3. Confirm that the vendor is on the Approved Vendor List (AVL). If not, escalate to QA before proceeding.
  3. Discrepancy Handling

    1. For missing or incorrect documents, place materials on hold and notify QA for further instructions.
    2. Document all discrepancies in the incident log, referencing the batch number and PO number.

5.3 Sampling and Quality Control

Once materials pass the basic visual check and documentation review, QC must verify quality through sampling and testing as per internal specifications.

  1. Sampling Request

    1. Once the initial inspection is complete, Warehouse Personnel alert QC to initiate sampling procedures.
    2. QA or QC verifies that the shipment is approved for sampling (i.e., no major discrepancies found).
  2. Sampling Procedure

    1. QC personnel don appropriate Personal Protective Equipment (PPE)—such as gloves, masks, and lab coats—based on material hazard classification.
    2. Follow the sampling plan that dictates sampling points, sample sizes, and the number of containers to sample. This plan should align with regulatory guidelines and internal risk assessments.
    3. Label samples clearly with the material name, batch/lot number, sampling date, and sampler’s initials.
    4. Record these details in the Sampling Log (refer to Annexure-2), ensuring traceability.
  3. Testing and Results

    1. QC performs analytical tests (e.g., pH, viscosity, microbial limits, etc.) in accordance with approved test methods.
    2. Compare results against the material’s approved specifications. Document all test outcomes in the QC laboratory records.
    3. Any Out of Specification (OOS) result must be communicated immediately to QA for further investigation.
  4. Data Review and Release Decision

    1. QC reviews all test data for accuracy and completeness.
    2. If test results meet specified standards, QC prepares a Material Release Report and forwards it to QA.
    3. If test results do not meet requirements, QA determines whether the batch should be rejected, reworked (if applicable), or if additional testing is warranted.
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5.4 Quarantine and Labeling

While QC evaluations are ongoing, the raw materials must remain in a controlled quarantine environment.

  1. Quarantine Storage

    1. Immediately after the initial receiving and visual inspection, segregate the materials in a designated “Quarantine” area.
    2. Ensure this area has restricted access to authorized personnel only and is labeled accordingly (“Under Inspection” or similar).
  2. Quarantine Labeling

    1. Affix a “Quarantine” label on each container, including the date received, the batch number, the PO number, and any special handling instructions (e.g., “Store in a cool, dry place”).
    2. Maintain an updated log of all quarantined materials, ensuring easy retrieval and monitoring for QC sampling and testing activities.
  3. Handling Precautions

    1. If hazardous materials are quarantined, follow all safety protocols detailed in their respective SDS (e.g., appropriate ventilation, use of PPE, spill containment measures).
    2. For temperature-sensitive materials, place them in designated cold storage or temperature-controlled rooms, marking them as “quarantined” appropriately.

5.5 Approval and Release

Once QC completes testing and QA reviews all results, the materials can be officially approved or rejected.

  1. Final Approval

    1. After QC compiles the test data and finds it satisfactory, QA reviews the data for final sign-off.
    2. QA stamps or signs a “Material Release Form” which authorizes Warehouse Personnel to move the material out of quarantine.
  2. Release Labeling

    1. Replace the “Quarantine” label with an “Approved” or “Released” label that specifies the release date and QA/QC authorization.
    2. Update the inventory management system to reflect the new status of the materials, including storage location and any special handling notes.
  3. Rejection Process

    1. If QC or QA determines that the material fails to meet specifications, label the containers as “Rejected,” and segregate them in a designated “Reject” area.
    2. Procurement or QA will communicate with the vendor regarding returns, replacements, or credits. Document the rejection in the incident log and the Raw Material Receiving Register, noting the reason for rejection.

5.6 Documentation and Record-Keeping

Thorough documentation of all receiving steps and related quality checks is essential for regulatory compliance, traceability, and effective inventory management.

See also  SOP for Immediate Quarantine of Raw Materials Suspected of Contamination - V 2.0

  1. Receiving Records

    1. Enter all pertinent details—delivery date, vendor name, material name, batch number, quantity received, PO number, and any observations—into the Raw Material Receiving Register (Annexure-1).
    2. Ensure each entry is signed or initialed by the responsible personnel, indicating accountability and traceability.
  2. Sampling Log

    1. QC team updates the Sampling Log (Annexure-2) with the sample collection date, sample ID, and tests performed.
    2. Attach or reference the lab test reports, CoA confirmations, and any deviation reports in the QC records.
  3. Archiving and Retention

    1. Archive receiving documents (e.g., delivery notes, CoAs, SDSs) in compliance with regulatory retention periods (e.g., five years or as required by local regulations).
    2. Maintain both physical and digital copies (if applicable) for quick retrieval during audits or inspections.
  4. Audit Trail

    1. All data entries should include a date, signature, or electronic stamp if using a validated computerized system.
    2. Any changes or corrections must follow an approved change control or data integrity procedure, ensuring traceability of modifications.

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
  • OOS: Out of Specification
  • AVL: Approved Vendor List
  • PPE: Personal Protective Equipment

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice 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 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 Vendor Name Material Name Batch Number Quantity Received PO Number Remarks
01/02/2025 ABC Suppliers Material A Batch 12345 500 kg PO-98765 No Damage
02/02/2025 XYZ Distributors Material B Batch 67890 300 kg PO-12345 Slight Box Tear

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result
01/02/2025 Material A Batch 12345 John Doe Moisture Content Pass
02/02/2025 Material B Batch 67890 Jane Smith Microbial Limits Fail

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 Created and issued the first version
01/02/2025 2.0 Format Revision and Updates Standardization of Document QA Head All All Revised layout; updated roles and responsibilities
Raw Material Warehouse V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,