SOP for Verifying Vendor Compliance Before Accepting Raw Materials – V 2.0

Posted on By Auditor

SOP for Verifying Vendor Compliance Before Accepting Raw Materials – V 2.0

Standard Operating Procedure for Verifying Vendor Compliance Before Accepting Raw Materials

Department Procurement / Quality Assurance / Quality Control / Warehouse
SOP No. SOP/RM/030/2025
Supersedes SOP/RM/030/2022
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 verifying vendor compliance before accepting raw materials into the facility. It ensures that all suppliers meet the required regulatory, quality, and safety standards prior to their materials being used in production. This verification process minimizes the risk of non-conforming materials, enhances product quality, and ensures compliance with Good Manufacturing Practices (GMP) and regulatory guidelines.

  • Ensure that vendors meet predefined quality and regulatory standards.
  • Prevent acceptance of raw materials from unapproved or non-compliant suppliers.
  • Facilitate traceability and accountability through systematic vendor evaluation and documentation.
  • Support continuous improvement through monitoring and evaluation of vendor performance.

2. Scope

This SOP applies to all vendors supplying raw materials to the facility, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials. It covers:

  • Initial vendor qualification and approval processes.
  • Ongoing monitoring and re-evaluation of vendor compliance.
  • Documentation and record-keeping related to vendor qualification.
  • Responsibilities of Procurement, Quality Assurance (QA), Quality Control (QC), and Warehouse teams in the vendor verification process.

3. Responsibilities

  • Procurement Department:

    • Ensure vendors are qualified and approved before placing purchase orders (POs).
    • Maintain up-to-date records of vendor certifications, audits, and compliance documents.
    • Coordinate with QA for vendor audits and re-evaluation processes.
    • Communicate with vendors regarding compliance requirements and corrective actions if needed.
  • Quality Assurance (QA) Team:

    • Establish criteria for vendor approval and re-evaluation based on regulatory standards and internal quality requirements.
    • Conduct vendor audits and reviews to verify compliance with GMP and other applicable standards.
    • Maintain the Approved Vendor List (AVL) and ensure only approved vendors supply raw materials.
    • Review vendor-supplied documentation, including Certificates of Analysis (CoAs), GMP certifications, and audit reports.
  • Quality Control (QC) Team:

    • Perform testing on incoming materials to verify that they meet the specifications provided by the vendor.
    • Report any discrepancies or non-conformances identified during material testing to QA and Procurement.
    • Provide feedback for vendor performance evaluations based on material quality.
  • Warehouse Personnel:

    • Verify that materials received are from approved vendors before accepting them into the facility.
    • Segregate and quarantine materials from unapproved or non-compliant vendors until QA makes a final decision.
    • Record all relevant information in the Raw Material Receiving Register (Annexure-1).
See also  SOP for Identifying and Reporting Deviations in Raw Material Receipt - V 2.0

4. Accountability

The Procurement Manager is responsible for ensuring that all vendors supplying raw materials are qualified and approved according to this SOP. The QA Manager has the authority to approve or reject vendors based on compliance evaluations, audits, and performance reviews. Any deviations from this SOP must be documented and approved by QA management to ensure compliance with GMP and regulatory requirements.

5. Procedure

5.1 Initial Vendor Qualification

  1. Vendor Identification and Pre-Screening

    1. Procurement identifies potential vendors and collects preliminary information, including company profile, certifications, and product offerings.
    2. Ensure the vendor provides required documentation such as GMP certifications, ISO certifications, and any other relevant compliance certificates.
  2. Vendor Questionnaire and Documentation Review

    1. Send a Vendor Qualification Questionnaire to collect detailed information on the vendor’s quality systems, manufacturing processes, and regulatory compliance.
    2. QA reviews the completed questionnaire along with supporting documents, such as:
      • GMP certificates and audit reports.
      • Certificates of Analysis (CoAs) for representative products.
      • Regulatory inspection histories and outcomes.
      • Batch production records and traceability information.
  3. On-Site or Remote Audit (if required)

    1. Based on the risk assessment and criticality of the materials, QA may conduct an on-site or remote audit of the vendor’s facility.
    2. Prepare an audit report summarizing findings, including any observations, non-conformances, and recommendations for improvement.
  4. Approval and Addition to the Approved Vendor List (AVL)

    1. QA reviews all collected information and audit findings to make a final decision on vendor approval.
    2. Approved vendors are added to the AVL, and Procurement is notified to proceed with placing POs for raw materials.
    3. Vendors not meeting the compliance requirements are rejected, and Procurement is informed to seek alternative suppliers.
See also  SOP for Sampling at Receiving Stage for Preliminary Inspection - V 2.0

5.2 Ongoing Vendor Monitoring

  1. Regular Performance Evaluation

    1. Procurement and QA jointly monitor vendor performance through periodic reviews of:
      • Quality of supplied materials based on QC test results.
      • Consistency in meeting delivery timelines and quantities.
      • Frequency of non-conformances or deviations related to the vendor’s materials.
  2. Re-Evaluation and Re-Audits

    1. QA conducts periodic re-evaluations and re-audits based on the vendor’s risk profile and performance history.
    2. Update the AVL based on re-evaluation outcomes, removing vendors who fail to maintain compliance.
  3. Handling Non-Conformances

    1. In cases of material non-conformance or deviations, QA investigates the root cause and coordinates with the vendor to implement corrective and preventive actions (CAPA).
    2. Document all non-conformances and CAPAs in the vendor performance record for future reference.

5.3 Receiving Raw Materials from Approved Vendors

  1. Verification at Receiving Stage

    1. Warehouse personnel verify that the materials received are from vendors listed on the AVL before accepting them into the facility.
    2. Cross-check vendor details on shipping documents with the AVL and PO information.
  2. Handling Materials from Unapproved Vendors

    1. If materials are received from an unapproved vendor, quarantine them immediately and notify QA and Procurement.
    2. QA will investigate and decide whether to reject the materials outright or proceed with an expedited vendor qualification process if necessary.
  3. Documentation and Record-Keeping

    1. Record all details related to vendor verification in the Raw Material Receiving Register (Annexure-1), including vendor name, approval status, and any observations.
    2. Maintain comprehensive records of vendor qualifications, audits, and performance reviews for future reference and regulatory audits.
See also  SOP for Inspection of Recycled or Reprocessed Raw Materials - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • CoA: Certificate of Analysis
  • CAPA: Corrective and Preventive Action
  • AVL: Approved Vendor List

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Vendor Qualification Questionnaire
  3. Vendor Audit Reports
  4. Certificates of Analysis (CoAs)
  5. GMP and ISO Certifications
  6. Deviation/Non-Conformance Reports

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 Vendor Management 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 Vendor Approval Status Remarks
01/02/2025 ABC Chemicals API-X X-2025-001 PO-12345 100 kg Approved No Issues
02/02/2025 XYZ Pharma Excipient-Y Y-2025-002 PO-67890 200 kg Unapproved Quarantined, Awaiting QA Review

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 vendor verification and compliance checks.
01/02/2025 2.0 Enhanced Vendor Monitoring Standardization of Document QA Head All All Added detailed guidelines for ongoing vendor monitoring and re-evaluation.
Raw Material Warehouse V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,