SOP Guide for Pharma

SOP for Handling and Storing Raw Materials in Open Shelving Systems – V 2.0

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SOP for Handling and Storing Raw Materials in Open Shelving Systems – V 2.0

Standard Operating Procedure for Handling and Storing Raw Materials in Open Shelving Systems

Department Warehouse / Quality Assurance
SOP No. SOP/RM/164/2025
Supersedes SOP/RM/164/2022
Page No. Page 1 of 14
Issue Date 01/04/2025
Effective Date 08/04/2025
Review Date 01/04/2026

1. Purpose

This Standard Operating Procedure (SOP) provides guidelines for the proper handling and storage of raw materials in open shelving systems. It ensures materials are protected from contamination, cross-contamination, and environmental degradation while maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials stored on open shelving systems within the warehouse, including active pharmaceutical ingredients (APIs), excipients, and packaging materials.

3. Responsibilities

  • Warehouse Personnel: Handle and store raw materials following this SOP. Ensure shelves are clean, organized, and materials are properly labeled.
  • Warehouse Supervisor: Oversee storage practices, verify compliance, and ensure environmental conditions are maintained.
  • Quality Assurance (QA): Conduct audits of storage conditions and ensure compliance with GMP requirements.

4. Accountability

The Warehouse Manager is accountable for the correct implementation of this SOP. The QA Manager is responsible for verifying compliance through routine inspections and audits.

5. Procedure

5.1 Preparation of Open Shelving Systems

  1. Shelving Requirements:
    • Use non-reactive, rust-proof, and easy-to-clean shelving materials such as stainless steel or coated metal.
    • Ensure shelves are stable, securely fastened, and capable of supporting the weight of stored materials.
    • Maintain a minimum distance of 6 inches from the floor to prevent moisture contamination.
    • Document shelving inspections in the Shelving Inspection Log (Annexure-1).
  2. Cleaning and Sanitization:
    • Clean and sanitize shelves before placing any raw materials, and perform regular cleaning based on a pre-defined schedule.
    • Document cleaning activities in the Shelving Cleaning Log (Annexure-2).
See also  SOP for Inventory Control of Raw Materials in Quarantine - V 2.0

5.2 Material Handling Procedures

  1. Receiving and Verification:
    • Upon receipt, verify that raw materials are free from damage and meet quality standards before storage.
    • Ensure materials are labeled correctly with batch number, material name, and expiration date.
    • Document material verification in the Material Receiving Log (Annexure-3).
  2. Placement on Shelves:
    • Arrange materials on shelves by type, batch number, and expiry date to facilitate FIFO (First In, First Out) or FEFO (First Expired, First Out) practices.
    • Ensure materials are not stacked beyond safe limits to avoid toppling.
    • Maintain at least 12 inches of space between materials and walls to promote air circulation.
    • Record shelf placement in the Material Placement Log (Annexure-4).

5.3 Environmental Monitoring and Maintenance

  1. Environmental Control:
    • Monitor temperature and humidity levels daily to ensure they remain within acceptable ranges for each material.
    • Install thermometers and hygrometers at strategic locations within the storage area.
    • Document environmental conditions in the Environmental Monitoring Log (Annexure-5).
  2. Routine Inspections:
    • Conduct weekly inspections to identify signs of contamination, spillage, or pest infestation.
    • Document inspection findings in the Storage Area Inspection Log (Annexure-6).
See also  SOP for Handling and Storing Raw Materials with Short Shelf Life - V 2.0

5.4 Handling Non-Conformities and Damaged Materials

  1. Identification of Issues:
    • If materials are found damaged, contaminated, or expired, they must be labeled as “Quarantined” and moved to a designated area.
    • Record non-conformities in the Non-Conformity Report (Annexure-7).
  2. Corrective Actions:
    • Investigate the cause of non-conformities and implement corrective actions.
    • Document corrective actions in the Corrective Action Log (Annexure-8).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • FIFO: First In, First Out
  • FEFO: First Expired, First Out

7. Documents

  1. Shelving Inspection Log (Annexure-1)
  2. Shelving Cleaning Log (Annexure-2)
  3. Material Receiving Log (Annexure-3)
  4. Material Placement Log (Annexure-4)
  5. Environmental Monitoring Log (Annexure-5)
  6. Storage Area Inspection Log (Annexure-6)
  7. Non-Conformity Report (Annexure-7)
  8. Corrective Action Log (Annexure-8)

8. References

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

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Shelving Inspection Log

Date Shelf Location Inspection Findings Inspected By
01/04/2025 Aisle 1, Shelf A No damage, secure installation Ravi Kumar
01/04/2025 Aisle 2, Shelf B Minor rust on lower frame Neha Verma

Annexure-2: Shelving Cleaning Log

Date Shelf Location Cleaning Method Cleaned By
01/04/2025 Aisle 1, Shelf A Sanitized with 70% IPA Amit Joshi
01/04/2025 Aisle 2, Shelf B Sanitized with disinfectant spray Priya Singh
See also  SOP for Verification of Testing Reports Before Releasing Materials from Quarantine - V 2.0

Annexure-3: Material Receiving Log

Date Material Name Batch Number Condition on Receipt Received By
01/04/2025 Paracetamol API PA-2025A Good Ravi Kumar
01/04/2025 Sodium Benzoate SB-2025B No damage Neha Verma

Annexure-4: Material Placement Log

Date Material Name Batch Number Shelf Location Placed By
01/04/2025 Paracetamol API PA-2025A Aisle 1, Shelf A Amit Joshi
01/04/2025 Sodium Benzoate SB-2025B Aisle 2, Shelf B Priya Singh

Annexure-5: Environmental Monitoring Log

Date Storage Area Temperature (°C) Humidity (%) Checked By
01/04/2025 Aisle 1 24°C 45% Amit Joshi
01/04/2025 Aisle 2 23°C 50% Priya Singh

Annexure-6: Storage Area Inspection Log

Date Storage Area Inspection Findings Inspected By
01/04/2025 Aisle 1 No issues Ravi Kumar
01/04/2025 Aisle 2 Pest droppings found Neha Verma

Annexure-7: Non-Conformity Report

Date Material Name Batch Number Non-Conformity Description Reported By
01/04/2025 Sodium Benzoate SB-2025B Pest contamination Neha Verma

Annexure-8: Corrective Action Log

Date Non-Conformity Corrective Action Taken Verified By
01/04/2025 Pest contamination in Aisle 2 Material quarantined, pest control performed Amit Joshi

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
01/04/2025 2.0 Added Non-Conformity and Corrective Action Procedures Enhance Storage Compliance QA Head
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