SOP Guide for Pharma

SOP for Documenting the Movement of Raw Materials Within Storage Areas – V 2.0

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SOP for Documenting the Movement of Raw Materials Within Storage Areas – V 2.0

Standard Operating Procedure for Documenting the Movement of Raw Materials Within Storage Areas

Department Warehouse / Quality Assurance
SOP No. SOP/RM/173/2025
Supersedes SOP/RM/173/2022
Page No. Page 1 of 15
Issue Date 08/04/2025
Effective Date 15/04/2025
Review Date 08/04/2026

1. Purpose

This Standard Operating Procedure (SOP) establishes the method for accurately documenting the movement of raw materials within storage areas to ensure traceability, prevent mix-ups, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all warehouse and quality assurance (QA) personnel responsible for the storage, movement, and tracking of raw materials in designated storage areas, including quarantine, approved, and rejected zones.

3. Responsibilities

4. Accountability

The Warehouse Manager is accountable for maintaining accurate movement records, and the QA Manager is responsible for ensuring compliance with documentation protocols.

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5. Procedure

5.1 Movement Authorization

  1. Request for Movement:
    • Submit a Raw Material Movement Request Form (Annexure-1) to the Warehouse Supervisor for approval.
    • Verify that the material’s status (quarantine, approved, or rejected) aligns with the movement request.
  2. Approval Process:
    • The Warehouse Supervisor reviews the request, confirms availability of storage space, and authorizes the movement.
    • Document approval details in the Movement Authorization Log (Annexure-2).

5.2 Material Movement Documentation

  1. Recording Movement Details:
    • Record each movement in the Raw Material Movement Log (Annexure-3), including material name, batch number, origin, destination, and reason for movement.
    • Ensure dual verification (by two warehouse personnel) of high-risk material movements.
  2. Barcode Scanning (if applicable):
    • Use barcode scanners to track movement electronically and link the data to the Warehouse Management System (WMS).
    • Maintain digital logs in the Electronic Movement Record (Annexure-4).

5.3 Special Handling and Segregation

  1. Hazardous and Sensitive Materials:
    • Follow special handling procedures for hazardous, temperature-sensitive, or light-sensitive materials.
    • Document these movements separately in the Special Material Movement Log (Annexure-5).
  2. Segregation Requirements:
    • Ensure materials with different statuses (approved, rejected, quarantined) are moved to clearly marked and segregated areas.
    • Update the Segregation Compliance Log (Annexure-6) after each movement.
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5.4 Reconciliation and Audit

  1. Daily Reconciliation:
    • At the end of each day, reconcile physical inventory with documented movements.
    • Record reconciliation findings in the Daily Movement Reconciliation Log (Annexure-7).
  2. QA Audits:
    • The QA department conducts weekly audits of movement records to verify compliance.
    • Document audit findings in the Movement Audit Log (Annexure-8).

5.5 Training and Compliance

  1. Employee Training:
    • Conduct quarterly training sessions for warehouse staff on movement documentation protocols.
    • Maintain training records in the Movement Documentation Training Log (Annexure-9).
  2. Regulatory Compliance:
    • Ensure that documentation practices align with GMP, FDA, and WHO standards.
    • Conduct bi-annual reviews of SOP effectiveness and compliance.

6. Abbreviations

7. Documents

  1. Raw Material Movement Request Form (Annexure-1)
  2. Movement Authorization Log (Annexure-2)
  3. Raw Material Movement Log (Annexure-3)
  4. Electronic Movement Record (Annexure-4)
  5. Special Material Movement Log (Annexure-5)
  6. Segregation Compliance Log (Annexure-6)
  7. Daily Movement Reconciliation Log (Annexure-7)
  8. Movement Audit Log (Annexure-8)
  9. Movement Documentation Training Log (Annexure-9)

8. References

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9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Raw Material Movement Request Form

Date Material Name Batch Number Current Location Requested Location Reason for Movement Requested By
08/04/2025 API X Batch 12345 Quarantine Area Approved Storage QC Approval Received Ravi Kumar

Annexure-2: Movement Authorization Log

Date Material Name Batch Number Authorized By Signature
08/04/2025 API X Batch 12345 Neha Verma

Annexure-3: Raw Material Movement Log

Date Material Name Batch Number Origin Destination Moved By Verified By
08/04/2025 API X Batch 12345 Quarantine Area Approved Storage Amit Joshi Priya Singh

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
08/04/2025 2.0 Updated movement documentation procedures and included electronic tracking logs. Regulatory Update QA Head
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