SOP for Verification of Certificate of Analysis (CoA) During Material Receipt – V 2.0

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SOP for Verification of Certificate of Analysis (CoA) During Material Receipt – V 2.0

Standard Operating Procedure for Verification of Certificate of Analysis (CoA) During Material Receipt

Department Quality Assurance / Quality Control
SOP No. SOP/RM/005/2025
Supersedes SOP/RM/005/2022
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) describes the systematic approach for verifying the Certificate of Analysis (CoA) for raw materials during the receipt process. The CoA provides critical information regarding the quality attributes of the material, including potency, purity, microbial limits, physical characteristics, and other parameters specified by regulatory and internal standards. Proper verification of the CoA ensures that the materials received conform to the established specifications and are suitable for further use in manufacturing or research, thereby minimizing the risk of product defects, contamination, or regulatory non-compliance.

2. Scope

This SOP applies to all incoming raw materials—active pharmaceutical ingredients (APIs), excipients, solvents, and other chemicals—requiring a CoA from the supplier or manufacturer. The procedure covers every stage from receiving the CoA alongside the shipment, performing a thorough check of all critical data and test parameters, comparing it with in-house specifications, and documenting any discrepancies or deviations. All personnel involved in the receipt, quality assurance, and quality control processes must follow this SOP to ensure consistent, compliant handling of CoAs.

3. Responsibilities

  • Warehouse Personnel:

    • Receive incoming raw materials and the accompanying documentation, including the CoA.
    • Record essential details such as receipt date, supplier name, purchase order (PO) number, and batch number in the Raw Material Receiving Register.
    • Forward the CoA and related documents to the Quality Assurance (QA) or Quality Control (QC) department for verification.
    • Quarantine materials until QA or QC confirms that the CoA matches internal requirements.
  • Quality Assurance (QA) Team:

    • Define the specification criteria for verifying CoAs, including key parameters such as assay limits, physical attributes, and microbial requirements.
    • Review the CoA for completeness, authenticity, and conformance to pre-approved specifications.
    • Collaborate with QC if additional testing or sampling is required based on the CoA review findings.
    • Authorize final material release or rejection based on the CoA, supplier history, and QC test results (if necessary).
    • Maintain records of any deviations or discrepancies discovered during verification.
  • Quality Control (QC) Team:

    • Compare the CoA parameters with in-house test data when internal testing is performed.
    • Advise on retesting or further evaluations if discrepancies between the CoA and QC results arise.
    • Document all test outcomes in the Sampling Log and communicate significant deviations to QA.
    • Support investigations into out-of-specification (OOS) findings related to CoA verification.
  • Procurement Department:

    • Ensure that the supplier or manufacturer provides a CoA meeting the agreed-upon format and content requirements.
    • Address repeated instances of incomplete or inconsistent CoAs by liaising with suppliers and updating the Approved Vendor List (AVL) accordingly.
    • Communicate any changes in material specifications to the supplier to keep CoA data relevant.
  • Regulatory Affairs (If Applicable):

    • Ensure CoA content aligns with applicable regulatory standards (e.g., pharmacopeial monographs, local regulations).
    • Provide guidance if the raw material requires additional documentation or specific analytical methods beyond standard CoA parameters.
See also  SOP for Inspection of Double-Checked and Double-Bagged Raw Materials - V 2.0

4. Accountability

The QA Manager (or delegated representative) holds final accountability for ensuring adherence to this SOP. Any revisions or deviations from this procedure must be documented and approved by QA management. The Warehouse Manager is accountable for initial receipt and handling of materials, while the QC Manager is accountable for corroborating CoA data with in-house test results (if applicable).

5. Procedure

5.1 Receipt of CoA

  1. Collecting Documentation

    1. Upon delivery of raw materials, the Warehouse Personnel must ensure that a CoA is provided along with the packing list, delivery note, and any other relevant documents.
    2. If the CoA is missing or incomplete (e.g., no batch number, missing test results), notify Procurement and QA immediately to resolve the issue.
  2. Preliminary Checks

    1. Match the CoA’s batch or lot number with the one on the material’s label. Any mismatch immediately flags the material for quarantine and follow-up investigation.
    2. Review the CoA’s date of issuance to ensure it is current and aligned with the batch production date or retest date specified by the supplier.

5.2 Verification of CoA Completeness

  1. Essential Information

    1. The CoA must clearly state the supplier’s or manufacturer’s name, address, and contact details, along with the batch or lot number, material name, and production date (if required).
    2. The CoA should list the parameters tested (e.g., appearance, identification, assay, purity, microbial limits, residual solvents) and the corresponding results or acceptance criteria.
    3. Check for any unique identification codes or authentication features like watermarks, barcodes, or electronic signatures if these are part of your supplier’s standard documentation practices.
  2. Signatures and Authorization

    1. Ensure the CoA is signed or electronically approved by an authorized representative of the supplier’s QC or QA department. Unsigned or “draft” CoAs are not acceptable for final release.
    2. For electronic CoAs, validate the authenticity of e-signatures or digital certificates in accordance with applicable data integrity requirements.

5.3 Comparing CoA Parameters Against Specifications

A key aspect of verifying CoAs is to compare each parameter with the company’s internal material specification or relevant pharmacopeial standards. This ensures that all critical quality attributes align with predefined acceptance criteria.

  1. Reference Specifications

    1. QA keeps the current approved specifications for each material readily accessible in either a physical file or a validated electronic system.
    2. Identify the critical and major parameters (e.g., assay, moisture content, microbial limits) that determine the material’s suitability for use.
  2. Parameter-by-Parameter Verification

    1. Compare each test result on the CoA with the corresponding specification limit. For example, if the acceptance range for assay is 98.0% to 102.0%, confirm that the reported result falls within this bracket.
    2. Note any minor discrepancies (e.g., a parameter tested but not in the company’s specification) and evaluate their potential impact in collaboration with QC or regulatory staff, if necessary.
    3. If the CoA provides additional tests (e.g., heavy metals, elemental impurities) not routinely checked in-house, ensure these are within the relevant pharmacopeial or regulatory limits.
  3. Critical vs. Non-Critical Parameters

    1. Parameters deemed critical (e.g., assay, identification, sterility for sterile excipients) must be within strict limits for acceptance. Non-conforming values usually prompt a rejection or hold decision.
    2. Non-critical parameters (e.g., color, odor) may have more flexible acceptance criteria. Minor deviations may be permissible if QA or QC conducts a risk assessment concluding no significant impact on product quality.
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5.4 Sampling and In-House Testing

  1. Justification for Testing

    1. In many cases, the CoA is supplemented by in-house QC testing to verify the reliability of the supplier’s results. This can be part of a routine program (e.g., reduced testing for qualified suppliers) or triggered by risk-based criteria.
    2. If the supplier is new or on probation due to past quality issues, increased frequency or scope of testing may be warranted.
  2. Sampling Procedure

    1. QC personnel collect samples following the approved sampling plan, wearing appropriate personal protective equipment (PPE) and adhering to GMP requirements to avoid cross-contamination.
    2. Document all sampling activity in the Sampling Log (Annexure-2). Record the material name, batch number, sampling date, and sampler’s initials.
  3. Laboratory Analysis

    1. Perform the analytical tests specified in the in-house procedure, focusing on critical parameters like assay, impurities, moisture content, or microbial limits.
    2. Compare the in-house test results with those indicated on the CoA. Any significant discrepancies or out-of-specification (OOS) results must prompt an immediate investigation to determine whether the supplier’s data is inaccurate or if other factors are at play.

5.5 Discrepancies and Deviation Management

During CoA verification, discrepancies can occur in supplier data, documentation completeness, or alignment with in-house specifications. Such instances must be handled systematically to maintain GMP compliance and protect product integrity.

  1. Minor Discrepancies

    1. Minor discrepancies (e.g., typographical errors in the supplier’s address or an unlisted secondary test parameter) should still be documented, but they may not necessarily warrant rejection of the batch. QA can initiate a follow-up with the supplier to update or correct the CoA.
    2. Record all findings in the Raw Material Receiving Register and attach an internal memo or Deviation Note if needed.
  2. Major Discrepancies

    1. Inconsistent batch numbers, mismatched assay results, or missing signatures constitute major discrepancies that typically require immediate quarantine of the material until resolved.
    2. QA opens a formal deviation or non-conformance record, referencing the suspect CoA and involving Procurement and QC to investigate supplier responsibility or potential shipping/handling errors.
  3. Corrective and Preventive Actions (CAPA)

    1. If repeated discrepancies occur with the same supplier, QA may require a corrective action plan from the vendor, possibly including additional training or revised documentation protocols on the supplier’s side.
    2. Procurement updates the Approved Vendor List if the supplier fails to address ongoing CoA issues, potentially suspending or downgrading their approved status.

5.6 Final Release or Rejection

Based on the CoA verification and any supplementary testing or investigation results, QA determines whether to release, quarantine, or reject the material.

See also  SOP for Unloading and Moving Raw Materials to the Quarantine Area - V 2.0

  1. Approval for Use

    1. If the CoA is consistent with internal specifications and, when applicable, in-house QC results confirm material compliance, QA provides a formal release. The Warehouse team then removes the quarantine label and applies an “Approved” label.
    2. Update the inventory management system or Raw Material Receiving Register to reflect the new status of the batch. Attach the verified CoA in both physical and electronic archives as per the organization’s retention policy.
  2. Material Hold

    1. If there are outstanding questions about the CoA’s validity, or if in-house testing yields results outside the expected range, QA places the material on hold. Additional testing or supplier queries may be required before a final decision is made.
    2. Record the hold status, specifying the reason (e.g., “OOS result,” “Incomplete CoA,” etc.), and store the materials in a segregated quarantine area. Only QA can authorize movement from this status after resolution.
  3. Rejection

    1. If the discrepancy is severe, such as irreconcilable test data or verifiable contamination, QA rejects the batch. The material is labeled “Rejected” and moved to the designated rejection area pending return to the supplier or disposal.
    2. Procurement contacts the supplier regarding credit or replacement as per contract terms. All rejection details, including supporting documents, are filed in the batch record for audit readiness.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • CoA: Certificate of Analysis
  • OOS: Out of Specification
  • CAPA: Corrective and Preventive Action
  • 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-Specific Material Specifications and Testing Protocols
  • 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 CoA Status PO Number Remarks
01/02/2025 ABC Pharmaceuticals API Z Lot A123 Complete PO-11111 Verified, No Discrepancies
02/02/2025 XYZ Chemicals Excipient A Batch E789 Incomplete PO-22222 Missing Signature

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result
01/02/2025 API Z Lot A123 John Doe Assay, Impurity Profile Pass
03/02/2025 Excipient A Batch E789 Jane Smith Identification, pH 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 CoA verification
01/02/2025 2.0 Format and Content Expansion Standardization of Document QA Head All All Added detailed steps for discrepancy handling, CAPA, and partial acceptance
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