SOP for Ensuring Adequate Spacing Between Stored Raw Materials – V 2.0

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SOP for Ensuring Adequate Spacing Between Stored Raw Materials – V 2.0

Standard Operating Procedure for Ensuring Adequate Spacing Between Stored Raw Materials

Department Warehouse / Quality Assurance / Production
SOP No. SOP/RM/153/2025
Supersedes SOP/RM/153/2022
Page No. Page 1 of 12
Issue Date 22/03/2025
Effective Date 29/03/2025
Review Date 22/03/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the guidelines for maintaining adequate spacing between stored raw materials in the warehouse. Proper spacing ensures easy access, minimizes the risk of cross-contamination, and promotes safe handling of materials, in compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all warehouse personnel responsible for the storage and arrangement of raw materials, including APIs, excipients, hazardous chemicals, and temperature-sensitive materials. It covers spacing requirements for various types of materials and storage conditions.

3. Responsibilities

  • Warehouse Personnel: Ensure correct placement and spacing of raw materials according to this SOP.
  • Warehouse Supervisor: Monitor compliance with spacing guidelines and ensure any deviations are reported.
  • Quality Assurance (QA): Conduct periodic audits to verify adherence to spacing protocols and regulatory compliance.
  • Warehouse Manager: Oversee the implementation of this SOP and coordinate with QA for corrective actions.

4. Accountability

The Warehouse Manager is accountable for ensuring that raw materials

are stored with adequate spacing. The QA Manager is responsible for verifying compliance during routine audits.

5. Procedure

5.1 General Spacing Guidelines

  1. Standard Spacing Requirements:
    • Maintain a minimum of 30 cm (12 inches) of space between the walls and stored materials to allow air circulation and pest control.
    • Leave at least 45 cm (18 inches) of clearance below sprinkler systems to ensure proper function in case of fire.
    • Ensure a minimum of 1-meter-wide aisles between rows of materials for safe movement and forklift access.
  2. Spacing for Different Material Types:
    • Hazardous materials must be stored separately with a minimum spacing of 50 cm (20 inches) from other materials.
    • Temperature-sensitive materials should be stored with additional spacing to allow uniform air circulation.
    • Document spacing arrangements in the Storage Arrangement Log (Annexure-1).
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5.2 Specific Storage Conditions

  1. Vertical Stacking Guidelines:
    • Do not stack materials higher than 1.5 meters unless supported by appropriate shelving.
    • Ensure heavier materials are placed at the bottom to prevent toppling.
    • Document vertical stacking practices in the Vertical Stacking Log (Annexure-2).
  2. Segregation of Incompatible Materials:
    • Store incompatible chemicals (e.g., acids and bases) in separate areas with a spacing of at least 2 meters.
    • Use barriers or partitions when necessary to prevent accidental mixing.
    • Record segregation practices in the Incompatible Material Segregation Log (Annexure-3).

5.3 Monitoring and Documentation

  1. Daily Monitoring:
    • Warehouse personnel must inspect storage areas daily to ensure proper spacing is maintained.
    • Document observations in the Daily Spacing Inspection Log (Annexure-4).
  2. Periodic QA Audits:
    • QA will conduct monthly audits to verify compliance with spacing requirements.
    • Document audit findings in the QA Spacing Audit Log (Annexure-5).

5.4 Handling Deviations and Corrective Actions

  1. Deviation Reporting:
    • Any deviations from spacing guidelines must be reported immediately to the Warehouse Supervisor using the Spacing Deviation Report (Annexure-6).
    • Corrective actions should be implemented within 24 hours of detection.
  2. Corrective and Preventive Actions (CAPA):
    • Document all corrective and preventive actions in the Spacing CAPA Log (Annexure-7).
    • QA must verify that corrective actions have been implemented and are effective.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • CAPA: Corrective and Preventive Action

7. Documents

  1. Storage Arrangement Log (Annexure-1)
  2. Vertical Stacking Log (Annexure-2)
  3. Incompatible Material Segregation Log (Annexure-3)
  4. Daily Spacing Inspection Log (Annexure-4)
  5. QA Spacing Audit Log (Annexure-5)
  6. Spacing Deviation Report (Annexure-6)
  7. Spacing CAPA Log (Annexure-7)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
  • OSHA Guidelines for Warehouse Safety

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Storage Arrangement Log

Date Material Name Batch Number Storage Location Spacing Verified Verified By
22/03/2025 Citric Acid CA-1234 Rack A1 Yes Ravi Kumar
22/03/2025 Sodium Hydroxide NAOH-5678 Rack B2 Yes Neha Verma

Annexure-2: Vertical Stacking Log

Date Material Name Batch Number Stack Height Compliant (Yes/No) Verified By
22/03/2025 Magnesium Stearate MS-3456 1.2 meters Yes Amit Joshi
22/03/2025 Potassium Chloride KCL-7890 1.6 meters No Priya Singh
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Annexure-3: Incompatible Material Segregation Log

Date Material 1 Material 2 Segregation Distance Barrier Used Verified By
22/03/2025 Hydrochloric Acid Sodium Hydroxide 2.5 meters Yes Neha Verma
22/03/2025 Acetic Acid Potassium Carbonate 2 meters Partition Wall Ravi Kumar

Annexure-4: Daily Spacing Inspection Log

Date Storage Area Spacing Compliance (Yes/No) Remarks Inspected By
22/03/2025 Rack A1 Yes — Amit Joshi
22/03/2025 Rack B2 No Spacing too narrow Priya Singh

Annexure-5: QA Spacing Audit Log

Date Storage Area Audit Findings Corrective Action Required Audited By
22/03/2025 Rack A1 Compliant None Neha Verma
22/03/2025 Rack B2 Overstacked materials Rearrange immediately Ravi Kumar

Annexure-6: Spacing Deviation Report

Date Deviation Identified Storage Location Reported By Action Taken
22/03/2025 Insufficient spacing between hazardous materials Hazardous Storage Area Amit Joshi Materials rearranged, verified by QA
22/03/2025 Stacking height exceeded Rack B3 Priya Singh Adjusted to compliant height

Annexure-7: Spacing CAPA Log

Date Identified Issue Corrective Action Preventive Action Implemented By Verified By
22/03/2025 Overstacking in Rack C1 Reduced stack height Staff retraining on stacking guidelines Ravi Kumar Neha Verma
22/03/2025 Inadequate spacing for light-sensitive materials Reorganized storage layout Monthly spacing audits 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
22/03/2025 2.0 Added spacing guidelines for hazardous materials To align with revised GMP standards QA Head
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