SOP for Identifying and Reporting Deviations in Raw Material Receipt – V 2.0

Posted on By Auditor

SOP for Identifying and Reporting Deviations in Raw Material Receipt – V 2.0

Standard Operating Procedure for Identifying and Reporting Deviations in Raw Material Receipt

Department Warehouse / Quality Assurance / Quality Control / Procurement
SOP No. SOP/RM/038/2025
Supersedes SOP/RM/038/2022
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) defines the process for identifying, documenting, and reporting deviations during the receipt of raw materials. Deviations can occur due to discrepancies in quantity, packaging, labeling, transportation conditions, or non-conformance with supplier documentation. This SOP ensures:

  • Systematic identification and reporting of deviations in raw material receipt.
  • Compliance with Good Manufacturing Practices (GMP) and regulatory requirements for deviation management.
  • Timely corrective and preventive actions (CAPA) to address and resolve deviations.
  • Accurate documentation and traceability of deviation reports for audit and review purposes.

2. Scope

This SOP applies to all raw materials received at the facility, covering the identification and reporting of deviations during receipt, inspection, and documentation. It includes:

  • Procedures for identifying deviations related to material quantity, packaging, labeling, transportation, and documentation.
  • Responsibilities of the Warehouse, Quality Assurance (QA), Quality Control (QC), and Procurement teams in managing deviations.
  • Corrective and preventive action (CAPA) processes to resolve deviations and prevent recurrence.
  • Documentation and record-keeping of deviation reports and related corrective actions.

3. Responsibilities

  • Warehouse Personnel:

    • Inspect raw materials upon receipt and identify any deviations from standard requirements.
    • Document deviations in the Raw Material Receiving Register (Annexure-1) and notify QA immediately.
    • Segregate and quarantine materials with identified deviations until further evaluation by QA.
  • Quality Assurance (QA) Team:

    • Review reported deviations and assess their impact on material quality and compliance.
    • Initiate deviation reports, investigate root causes, and coordinate corrective and preventive actions (CAPA).
    • Approve or reject materials based on deviation assessments and ensure proper documentation.
  • Quality Control (QC) Team:

    • Conduct additional testing or sampling as required to assess the impact of deviations on material quality.
    • Provide analytical data to support QA in deviation resolution and material disposition decisions.
  • Procurement Department:

    • Coordinate with suppliers to address deviations related to material specifications, documentation, or transportation conditions.
    • Ensure suppliers implement corrective actions to prevent recurrence of deviations.
See also  SOP for Accepting and Handling of Herbal Raw Materials - V 2.0

4. Accountability

The Warehouse Manager is responsible for identifying and reporting deviations during raw material receipt. The QA Manager holds the authority to investigate deviations, implement corrective actions, and approve or reject materials based on deviation assessments. The Procurement Manager is responsible for coordinating with suppliers to address and resolve deviations.

5. Procedure

5.1 Identification of Deviations

  1. Inspection During Material Receipt

    1. Warehouse personnel inspect raw materials upon receipt for the following potential deviations:
      • Quantity Discrepancies: Mismatch between received quantity and purchase order (PO).
      • Packaging Damage: Torn, punctured, or leaking packaging.
      • Labeling Errors: Incorrect or missing labels, batch numbers, or expiration dates.
      • Transportation Deviations: Temperature excursions, improper handling, or damaged seals.
      • Documentation Issues: Missing or incomplete Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), or other supplier documents.
  2. Immediate Reporting to QA

    1. Warehouse personnel document identified deviations in the Raw Material Receiving Register (Annexure-1).
    2. Notify QA immediately of any deviations and segregate the affected materials in a designated quarantine area.

5.2 Deviation Documentation and Reporting

  1. Initiation of Deviation Report

    1. QA initiates a Deviation Report (Annexure-2) upon notification of a deviation from the Warehouse or QC teams.
    2. Include the following details in the Deviation Report:
      • Deviation description, including material name, batch number, and nature of the deviation.
      • Date and time of deviation identification.
      • Personnel involved in the receipt and inspection process.
  2. Root Cause Investigation

    1. QA conducts a root cause investigation to determine the source of the deviation, considering factors such as:
      • Supplier errors in packaging, labeling, or documentation.
      • Transportation issues, including temperature excursions or handling mishaps.
      • Internal process deviations during receipt or inspection.
See also  SOP for Documentation of Transit Conditions for Sensitive Raw Materials - V 2.0

5.3 Corrective and Preventive Actions (CAPA)

  1. Implementation of Corrective Actions

    1. QA coordinates with the Warehouse, QC, and Procurement teams to implement corrective actions based on the root cause investigation, such as:
      • Re-inspection or re-testing of materials by QC.
      • Supplier notification and request for corrected documentation or material replacement.
      • Improvement of internal processes or training to prevent recurrence.
  2. Verification of Corrective Actions

    1. QA verifies the effectiveness of corrective actions through follow-up inspections, audits, or supplier feedback.
    2. Document the verification process in the Deviation Report and update the Raw Material Receiving Register accordingly.

5.4 Final Disposition of Materials

  1. Approval or Rejection of Materials

    1. QA determines the final disposition of materials based on deviation assessments and corrective action outcomes:
      • Materials that meet quality and compliance standards after corrective actions are labeled “Accepted” and moved to designated storage areas.
      • Materials that fail to meet standards are labeled “Rejected” and moved to the rejection area with appropriate documentation.
  2. Supplier Communication and Documentation

    1. Procurement communicates with suppliers regarding deviation findings and corrective actions.
    2. Ensure that suppliers implement preventive measures to avoid recurrence and document all communications.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PO: Purchase Order
  • MSDS: Material Safety Data Sheet
  • CoA: Certificate of Analysis
  • CAPA: Corrective and Preventive Action
See also  SOP for Physical and Visual Inspection of Incoming Raw Materials - V 2.0

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Deviation Report (Annexure-2)
  3. Certificates of Analysis (CoAs) and Material Safety Data Sheets (MSDS)
  4. Non-Conformance Reports and CAPA Logs

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 Warehouse 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 Deviation Identified Remarks
01/02/2025 ABC Chemicals API-X X-2025-001 PO-12345 100 kg Packaging Damaged Quarantined, Pending QA Review
02/02/2025 XYZ Pharma Excipient-Y Y-2025-002 PO-67890 200 kg Incorrect Batch Number Rejected, Supplier Notified

Annexure-2: Deviation Report

Deviation Number Date Material Name Batch Number Description of Deviation Root Cause Corrective Action Preventive Action Status
DEV-001/2025 01/02/2025 API-X X-2025-001 Packaging Damaged Improper Handling During Transit Supplier Replaced Material Improved Packaging Protocols Closed
DEV-002/2025 02/02/2025 Excipient-Y Y-2025-002 Incorrect Batch Number Supplier Labeling Error Material Rejected, Supplier Corrected Documentation Supplier Implemented Double-Check Process Closed

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 identifying and reporting deviations in raw material receipt.
01/02/2025 2.0 Added CAPA Documentation and Supplier Coordination Steps Standardization of Document QA Head All All Enhanced deviation reporting and corrective action processes.
Raw Material Warehouse V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,