SOP for Verification of Supplier Documents for Raw Materials – V 2.0

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SOP for Verification of Supplier Documents for Raw Materials – V 2.0

Standard Operating Procedure for Verification of Supplier Documents for Raw Materials

Department Quality Assurance / Procurement
SOP No. SOP/RM/002/2025
Supersedes SOP/RM/002/2022
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 define a comprehensive, GMP-compliant process for verifying all supplier-provided documents pertaining to incoming raw materials. This includes but is not limited to Certificates of Analysis (CoAs), Safety Data Sheets (SDS), technical specifications, and other relevant documentation that ensures materials meet our quality, safety, and regulatory requirements. Verifying supplier documents is a critical step in maintaining product integrity and mitigating risks such as substandard materials, incorrect labeling, or incomplete data.

2. Scope

This SOP applies to all raw materials procured from external suppliers for use in manufacturing. It encompasses the roles of the Procurement Department, Quality Assurance (QA), Quality Control (QC), and Warehouse Personnel in reviewing and verifying supplier documents. The scope includes initial document checks upon receipt, compliance assessments against internal specifications, and the final approval or rejection process based on document conformity and authenticity.

3. Responsibilities

  • Procurement Department:
    • Obtain and file all necessary supplier documents (CoA, SDS, technical specifications) before or at the time of delivery.
    • Ensure that the supplier is on the Approved Vendor List (AVL) and that all POs clearly state the requirement for complete and correct documentation.
    • Liaise with suppliers to resolve document discrepancies or omissions.
  • Warehouse Personnel:
    • Receive incoming raw materials and ensure that the corresponding documents (delivery note, CoA, SDS, etc.) are handed over to QA/QC for verification.
    • Record pertinent receiving details in the Raw Material Receiving Register.
  • Quality Assurance (QA) Team:
    • Oversee the verification process to ensure compliance with company SOPs and regulatory requirements.
    • Review and approve or reject documents that do not meet the required standards.
    • Maintain and periodically review the Approved Vendor List in collaboration with Procurement.
  • Quality Control (QC) Team:
    • Cross-check CoA specifications against internal test results and acceptance criteria.
    • Notify QA of any discrepancies in supplier documentation or test data.
    • Collaborate with QA to decide on material release or rejection based on document verification outcomes.
  • Safety and Compliance Officers (If Applicable):
    • Review SDS for completeness and current regulatory compliance, especially for hazardous or high-risk materials.
    • Advise on safe handling procedures for materials with specific regulatory requirements (e.g., flammable, corrosive).

4. Accountability

The QA Manager (or equivalent) holds overall accountability for ensuring adherence to this SOP. Any updates, changes, or revisions must be reviewed and approved by QA Management to maintain alignment with GMP standards and other regulatory guidelines.

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5. Procedure

5.1 Receiving Raw Materials

Although this SOP focuses on document verification, the initial receipt of raw materials sets the stage for a thorough document check.

  1. Material Arrival and Initial Checks

    1. Upon arrival, Warehouse Personnel should retrieve the relevant documents (delivery note, packing list) from the supplier.
    2. Verify the number of packages and match them with the Purchase Order (PO) details.
    3. Record essential receiving information—date, supplier name, PO number, and any immediately visible discrepancies—in the Raw Material Receiving Register (Annexure-1).
  2. Document Hand-Over to QA/QC

    1. Warehouse Personnel forward all supplier documents to QA/QC for verification, ensuring that Certificates of Analysis (CoA), Safety Data Sheets (SDS), and any other relevant technical data sheets are included.
    2. Procurement Department must be notified if key documents are missing, outdated, or incomplete.

5.2 Visual Inspection and Documentation Verification

Before proceeding to in-depth document verification, a basic visual inspection confirms that the supplier documents correspond to the actual raw materials received.

  1. Label and Package Consistency

    1. Confirm that labels on raw material containers match the information on the supplier documents (material name, batch number, expiry date).
    2. Check for major discrepancies—such as a mismatch in lot numbers or material names—and report these immediately to QA.
  2. Document Completeness

    1. Review each document for completeness:
      • CoA: Must include batch/lot number, test methods, and results.
      • SDS: Must comply with local regulations, be current, and detail hazard information.
      • Technical Data Sheets: Should list key product attributes and specifications when applicable.
    2. Any missing or incomplete fields (e.g., missing test results on CoA) must be addressed before the material can proceed.
  3. Discrepancy Management

    1. If labels and documents do not match, mark the material for “On Hold” status, and quarantine it until the discrepancy is resolved.
    2. Procurement should contact the supplier to request updated or corrected documents. QA must be informed of all communications regarding discrepancies.

5.3 Sampling and Quality Control

Although this SOP emphasizes document verification, confirming document accuracy also involves correlating the CoA data with internal QC testing.

  1. Sampling Authorization

    1. Once QA confirms that the supplier documentation is complete and appears consistent, QC may proceed with sampling.
    2. Materials with clearly insufficient or incorrect documentation should not be sampled until the discrepancy is resolved.
  2. Correlation with Internal Specs

    1. QC tests the material according to approved procedures (e.g., pH, microbial limits, potency, etc.).
    2. Compare QC test results to the specifications stated in the supplier’s CoA. Document any deviations or anomalies.
  3. OOS (Out of Specification) Protocol

    1. If the QC results significantly deviate from the CoA values, initiate an OOS investigation. QA will guide further actions, which may include re-testing, corrective actions, or rejecting the batch.
    2. Log all details in the Sampling Log (Annexure-2) for traceability.
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5.4 Quarantine and Labeling

Materials under document verification or awaiting resolution of discrepancies remain in a quarantined state to prevent accidental use.

  1. Quarantine Status

    1. Mark all materials as “Quarantined” or “On Hold” until QA provides clearance based on satisfactory document verification and QC testing.
    2. Use color-coded labels or tags to indicate quarantine status clearly, including reference to the pending document verification if necessary.
  2. Secure Storage

    1. Store quarantined materials in a designated area with restricted access.
    2. Ensure any special conditions (temperature, humidity) are met as required by the SDS and company guidelines.
  3. Document Status Visibility

    1. Maintain an updated log or electronic system that flags the materials under quarantine specifically for “Document Verification.”
    2. QA or QC personnel should note the reason for quarantine (e.g., “Awaiting updated CoA” or “Pending SDS review”).

5.5 Approval and Release

Once supplier documents are verified against internal requirements and QC test results confirm material conformity, QA grants final approval or rejects the material if discrepancies cannot be resolved.

  1. Final Document Check

    1. QA reviews the CoA against QC test results for alignment. QA also confirms that the SDS, technical specs, and any regulatory certificates are complete and valid.
    2. For sensitive or high-value materials, a second-level review may be conducted by a senior QA staff or a subject matter expert.
  2. Release Labeling

    1. If all criteria are met, QA authorizes a “Release” label to replace the quarantine tag.
    2. Update the inventory management system to reflect the release date, batch number, and any specific handling instructions derived from the verified SDS or other documents.
  3. Rejection Process

    1. If the documents fail verification or the material does not meet specifications, the batch is marked “Rejected.” QA logs the reason for rejection and notifies Procurement to coordinate return or disposal.
    2. Retain copies of the rejected documentation for audit and traceability purposes, following the standard retention schedule.

5.6 Documentation and Record-Keeping

Proper documentation of all verification steps ensures traceability and compliance with both internal policies and external regulatory requirements.

  1. Receiving Records

    1. Record all incoming shipments in the Raw Material Receiving Register (Annexure-1), noting the supplier name, date, PO number, and any discrepancies discovered.
    2. Ensure each entry is signed or initialed by the individual responsible for the record.
  2. QC Sampling Log

    1. QC must document the sampling date, tests performed, and results in the Sampling Log (Annexure-2).
    2. Attach or reference CoAs and any other supplier documents in relevant QC files or electronic databases for easy retrieval.
  3. Document Verification Checklist

    1. QA may use an internal “Document Verification Checklist” to systematically confirm that each supplier-provided document meets minimum requirements.
    2. File the completed checklist with the material batch records, CoAs, and SDS for future audits.
  4. Archiving

    1. Maintain a physical or electronic archive of all verified supplier documents for the retention period mandated by regulatory guidelines or company policy (e.g., five years or more).
    2. Ensure restricted access to archived documents, with controlled permissions for modifications or retrieval.
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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

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-Specific Approved Vendor List (AVL) and Internal Specifications

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 Quantity Received PO Number Document Check
01/02/2025 ABC Chemicals Material X Lot 101 200 kg PO-55555 Complete
02/02/2025 XYZ Supplies Material Y Lot 202 150 kg PO-66666 CoA Missing

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result
01/02/2025 Material X Lot 101 John Doe Assay, Purity Pass
02/02/2025 Material Y Lot 202 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 Established procedure for document verification
01/02/2025 2.0 Revised Format and Clarifications Standardization of Document QA Head All All Incorporated additional checks for SDS completeness and updated roles
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