SOP for Documentation and Record-Keeping of Received Raw Materials – V 2.0

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SOP for Documentation and Record-Keeping of Received Raw Materials – V 2.0

Standard Operating Procedure for Documentation and Record-Keeping of Received Raw Materials

Department Warehouse / Quality Assurance / Quality Control / Procurement
SOP No. SOP/RM/034/2025
Supersedes SOP/RM/034/2022
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) establishes the guidelines for systematic documentation and record-keeping of all raw materials received at the facility. Proper documentation ensures traceability, accountability, and compliance with Good Manufacturing Practices (GMP) and regulatory requirements. This SOP outlines:

  • Procedures for accurate recording of raw material receipt, inspection, and approval processes.
  • Maintenance of documentation for audit readiness and regulatory compliance.
  • Storage, retrieval, and control of raw material records to ensure data integrity and security.
  • Roles and responsibilities of personnel in managing documentation for raw material receipt.

2. Scope

This SOP applies to all departments involved in the receipt and handling of raw materials, including the Warehouse, Quality Assurance (QA), Quality Control (QC), and Procurement. It covers:

  • Documentation requirements for receiving, inspecting, and releasing raw materials.
  • Record-keeping of supplier documentation, Certificates of Analysis (CoAs), and regulatory certificates.
  • Procedures for managing deviations, non-conformances, and corrective actions related to raw materials.
  • Retention and archiving of records in compliance with regulatory standards.

3. Responsibilities

  • Warehouse Personnel:

    • Ensure accurate documentation of raw material receipts, including supplier information, batch numbers, and inspection results.
    • Maintain the Raw Material Receiving Register and ensure timely updates with relevant data.
    • Ensure that all documentation is complete, legible, and free from unauthorized alterations.
  • Quality Assurance (QA) Team:

    • Review and verify the completeness and accuracy of raw material documentation.
    • Ensure compliance with GMP and regulatory requirements for record-keeping.
    • Oversee the archiving and retrieval of raw material records and ensure proper retention periods are followed.
  • Quality Control (QC) Team:

    • Document sampling and testing results for raw materials in accordance with SOPs.
    • Ensure test reports, CoAs, and analytical data are properly stored and accessible for review.
  • Procurement Department:

    • Maintain supplier-related documentation, including purchase orders, invoices, and compliance certificates.
    • Coordinate with suppliers to obtain missing or incomplete documentation.
See also  SOP for Coordination Between Logistics and Warehouse Teams for Receipt of Raw Materials - V 2.0

4. Accountability

The Warehouse Manager is responsible for ensuring accurate documentation of raw material receipts. The QA Manager holds the authority to approve documentation processes and ensure compliance with GMP and regulatory requirements. Any deviations from this SOP must be documented and approved by QA to maintain compliance.

5. Procedure

5.1 Pre-Receipt Documentation

  1. Review of Purchase Orders and Supplier Documentation

    1. Procurement provides the Warehouse with the purchase order (PO) and supplier documentation, including invoices, packing lists, and Certificates of Analysis (CoAs).
    2. Ensure that all supplier documentation is complete and matches the PO details, including material name, quantity, and batch number.
  2. Preparation of Raw Material Receiving Register

    1. Ensure that the Raw Material Receiving Register (Annexure-1) is updated and ready for recording incoming materials.
    2. Prepare any additional forms required for documenting inspections and QC testing.

5.2 Receiving and Documentation

  1. Recording Receipt Details

    1. Upon receipt of raw materials, Warehouse personnel record the following details in the Raw Material Receiving Register:
      • Date of receipt.
      • Supplier name and contact information.
      • Material name, batch number, and quantity received.
      • Purchase order (PO) number and invoice number.
    2. Ensure that all entries are legible, complete, and made using permanent ink.
  2. Documentation of Inspection Results

    1. Record inspection findings, including packaging integrity, labeling accuracy, and any discrepancies observed during visual checks.
    2. Indicate whether the materials were accepted, quarantined, or rejected based on the inspection results.
See also  SOP for Receiving Raw Materials with Special Handling Instructions - V 2.0

5.3 Quality Assurance Review

  1. Verification of Documentation

    1. QA reviews the Raw Material Receiving Register and associated documentation to ensure accuracy and completeness.
    2. Cross-verify supplier CoAs, compliance certificates, and any regulatory documentation provided with the shipment.
  2. Approval and Filing of Documentation

    1. Once verified, QA approves the documentation and ensures it is properly filed and stored in the raw material documentation archive.
    2. Ensure that electronic records, if maintained, are backed up and secured in compliance with data integrity standards.

5.4 Record Retention and Archiving

  1. Retention Periods

    1. Maintain raw material documentation for a minimum of five years or as specified by regulatory guidelines.
    2. Ensure that records related to critical materials or long-term stability studies are retained for extended periods as required.
  2. Archiving Procedures

    1. Store physical records in a secure, fireproof, and humidity-controlled environment.
    2. Ensure that electronic records are stored on secure servers with appropriate access controls and regular backups.
    3. Label archived records clearly with reference numbers for easy retrieval during audits or inspections.

5.5 Handling Deviations and Non-Conformances

  1. Documentation of Deviations

    1. Record any deviations or non-conformances related to raw material receipt in the Deviation Report Form.
    2. Include details such as the nature of the deviation, corrective actions taken, and the responsible personnel involved.
  2. Review and Approval of Deviations

    1. QA reviews all deviation reports and ensures that appropriate corrective and preventive actions (CAPAs) are implemented.
    2. Maintain a log of all deviations and ensure that they are readily accessible for review during audits.

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
See also  SOP for Assigning Goods Receipt Note (GRN) Number to Received Materials - V 2.0

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Sampling Log (Annexure-2)
  3. Purchase Orders (PO), Invoices, and Packing Lists
  4. Certificates of Analysis (CoAs) and Compliance Certificates
  5. Deviation Reports and Non-Conformance 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 Inspection Findings Remarks
01/02/2025 ABC Chemicals API-X X-2025-001 PO-12345 100 kg Packaging Intact, CoA Verified Accepted
02/02/2025 XYZ Pharma Excipient-Y Y-2025-002 PO-67890 200 kg Labeling Discrepancy Found Quarantined, Pending QA Review

Annexure-2: Sampling Log

Date Material Name Batch Number Sampling Personnel QC Test Performed Result Remarks
01/02/2025 API-X X-2025-001 John Doe Identity Test Pass Approved for Use
03/02/2025 Excipient-Y Y-2025-002 Jane Smith Purity Test Fail Rejected Due to Labeling Error

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 documentation procedures for raw material receipt.
01/02/2025 2.0 Enhanced Record-Keeping and Archiving Procedures Standardization of Document QA Head All All Added retention periods and electronic record management guidelines.
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