SOP Guide for Pharma

SOP for Documentation of Raw Material Issuance in ERP System – V 2.0

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SOP for Documentation of Raw Material Issuance in ERP System – V 2.0

Standard Operating Procedure for Documentation of Raw Material Issuance in ERP System

Department Warehouse / Production / Quality Assurance
SOP No. SOP/RM/200/2025
Supersedes SOP/RM/200/2022
Page No. Page 1 of 15
Issue Date 05/05/2025
Effective Date 12/05/2025
Review Date 05/05/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for documenting raw material issuance in the Enterprise Resource Planning (ERP) system to ensure traceability, accuracy, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all warehouse, production, and quality assurance personnel involved in the documentation, verification, and issuance of raw materials using the ERP system in pharmaceutical manufacturing.

3. Responsibilities

  • Warehouse Staff: Accurately document raw material issuance in the ERP system.
  • Production Supervisor: Verify ERP entries before material usage in manufacturing.
  • Quality Assurance (QA) Team: Oversee ERP documentation compliance and conduct audits.

4. Accountability

The Warehouse Manager is accountable for the correct documentation of raw material issuance in the ERP system. The Production Supervisor ensures the accuracy of ERP records before usage, while the QA Manager ensures compliance through regular audits.

5. Procedure

5.1 Preparation for ERP Documentation

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  • Review of Batch Manufacturing Record (BMR):
    • Review the BMR to identify the required raw materials and quantities for issuance.
    • Record the review in the BMR Review Log (Annexure-1).
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  • ERP System Access:
    • Ensure authorized personnel have access to the ERP system for documentation.
    • Document system access in the ERP Access Log (Annexure-2).

    • 5.2 Documentation Process in ERP

    1. Entering Raw Material Details:
      • Log into the ERP system and navigate to the raw material issuance module.
      • Enter details such as material name, batch number, quantity, and date of issuance.
      • Document the entries in the ERP Entry Log (Annexure-3).
    2. Verification of ERP Entries:
      • Cross-check ERP entries against the BMR to ensure accuracy.
      • Document verification in the ERP Verification Log (Annexure-4).

    5.3 Handling Discrepancies in ERP Documentation

    1. Identification of Discrepancies:
      • Report any discrepancies in ERP entries immediately to QA for review.
      • Document discrepancies in the ERP Discrepancy Log (Annexure-5).
    2. Corrective Actions:
      • Implement corrective actions for discrepancies as recommended by QA.
      • Document corrective actions in the ERP Corrective Action Log (Annexure-6).

    5.4 Approval and Finalization

    1. Final Approval of ERP Entries:
      • Ensure all ERP entries are reviewed and approved by the Warehouse Manager and QA.
      • Document final approval in the ERP Approval Log (Annexure-7).
    2. Finalization of Issuance:
      • Confirm the issuance of materials based on verified ERP entries before transferring to production.
      • Document the final issuance in the Final Issuance Log (Annexure-8).
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    5.5 Training and Compliance Monitoring

    1. Training on ERP Documentation:
      • Conduct regular training sessions for warehouse and production staff on ERP documentation procedures.
      • Document training sessions in the ERP Training Log (Annexure-9).
    2. Compliance Audits:
      • QA personnel conduct periodic audits to ensure ERP documentation compliance.
      • Record audit findings in the Compliance Audit Log (Annexure-9).

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • ERP: Enterprise Resource Planning
    • BMR: Batch Manufacturing Record
    • QA: Quality Assurance
    • GMP: Good Manufacturing Practices

    7. Documents

    1. BMR Review Log (Annexure-1)
    2. ERP Access Log (Annexure-2)
    3. ERP Entry Log (Annexure-3)
    4. ERP Verification Log (Annexure-4)
    5. ERP Discrepancy Log (Annexure-5)
    6. ERP Corrective Action Log (Annexure-6)
    7. ERP Approval Log (Annexure-7)
    8. Final Issuance Log (Annexure-8)
    9. ERP Training Log (Annexure-9)

    8. References

    • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
    • WHO Guidelines on GMP for Pharmaceutical Products
    • FDA Guidance on ERP System Management in Pharmaceutical Manufacturing

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    Annexure-1: BMR Review Log

    Date BMR Number Reviewed By Remarks
    05/05/2025 BMR-23456 Ravi Kumar Reviewed and Approved

    Annexure-2: ERP Access Log

    Date User ID Access Level Authorized By
    05/05/2025 USR001 Full Access Neha Verma
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    Annexure-3: ERP Entry Log

    Date Material Name Batch Number Quantity (kg) Entered By
    05/05/2025 Paracetamol API BN-78901 20 kg Kiran Patel

    Annexure-4: ERP Verification Log

    Date Material Name Batch Number Verified By
    05/05/2025 Paracetamol API BN-78901 Amit Joshi

    Annexure-5: ERP Discrepancy Log

    Date Discrepancy Identified Description Reported By
    05/05/2025 Incorrect Batch Entry Batch number mismatch in ERP system QA Team

    Annexure-6: ERP Corrective Action Log

    Date Issue Corrective Action Taken Performed By
    05/05/2025 Incorrect Batch Entry Corrected the ERP entry Warehouse Staff

    Annexure-7: ERP Approval Log

    Date Material Name Batch Number Approved By
    05/05/2025 Paracetamol API BN-78901 QA Head

    Annexure-8: Final Issuance Log

    Date Material Name Batch Number Issued To
    05/05/2025 Paracetamol API BN-78901 Production Department

    Annexure-9: ERP Training Log

    Date Employee Name Training Topic Trainer Remarks
    05/05/2025 Neha Verma ERP Documentation Procedures QA Manager Completed Successfully

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial Version New SOP Implementation QA Head
    05/05/2025 2.0 Included detailed ERP documentation and discrepancy handling procedures. Regulatory Update QA Head