SOP Guide for Pharma

SOP for Managing Storage of Dry and Liquid Raw Materials Separately – V 2.0

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SOP for Managing Storage of Dry and Liquid Raw Materials Separately – V 2.0

Standard Operating Procedure for Managing Storage of Dry and Liquid Raw Materials Separately

Department Warehouse / Quality Assurance / Safety
SOP No. SOP/RM/158/2025
Supersedes SOP/RM/158/2022
Page No. Page 1 of 12
Issue Date 27/03/2025
Effective Date 03/04/2025
Review Date 27/03/2026

1. Purpose

This Standard Operating Procedure (SOP) establishes guidelines for the proper segregation and storage of dry and liquid raw materials to prevent cross-contamination, ensure safety, and maintain material integrity. This procedure aligns with Good Manufacturing Practices (GMP) and safety standards for raw material handling.

2. Scope

This SOP applies to all personnel involved in the handling and storage of dry and liquid raw materials in the warehouse. It includes procedures for the identification, labeling, segregation, and monitoring of these materials to ensure compliance with GMP.

3. Responsibilities

  • Warehouse Personnel: Ensure correct storage of dry and liquid materials as per this SOP. Report any deviations or storage issues immediately.
  • Warehouse Supervisor: Oversee storage operations, verify segregation procedures, and ensure proper labeling.
  • Quality Assurance (QA): Conduct regular audits to ensure compliance with storage requirements and verify documentation.
  • Safety Officer: Ensure storage areas meet safety standards, especially for flammable or hazardous liquids.

4. Accountability

The Warehouse Manager is accountable for ensuring the proper segregation and storage of dry and liquid raw materials. The QA Manager is responsible for regular audits and ensuring compliance with this SOP.

See also  SOP for Verification and Compliance of Storage Conditions Before Receipt - V 2.0

5. Procedure

5.1 Identification and Labeling of Dry and Liquid Raw Materials

  1. Material Classification:
    • Classify raw materials as either Dry (e.g., powders, granules) or Liquid (e.g., solvents, oils).
    • Hazardous materials must be identified based on their chemical properties and MSDS (Material Safety Data Sheet).
    • Document classifications in the Material Classification Log (Annexure-1).
  2. Labeling Requirements:
    • Clearly label all materials with their classification, batch number, storage requirements, and hazard symbols if applicable.
    • Use color-coded labels to distinguish dry (e.g., blue) from liquid (e.g., red) materials.
    • Document labeling status in the Material Labeling Log (Annexure-2).

5.2 Segregation and Storage Procedures

  1. Dedicated Storage Areas:
    • Store dry materials in dedicated, moisture-free storage areas to prevent humidity exposure.
    • Store liquid materials in separate, well-ventilated storage areas with spill containment measures.
    • Flammable liquids must be stored in fireproof cabinets with appropriate ventilation.
    • Document storage locations in the Material Storage Log (Annexure-3).
  2. Stacking and Shelving:
    • Ensure dry materials are stored on pallets or shelves to avoid direct contact with the floor.
    • Store liquid materials in leak-proof containers on secondary containment trays.
    • Document stacking and shelving arrangements in the Storage Arrangement Log (Annexure-4).
See also  SOP for Handling and Movement of Quarantined Hazardous Raw Materials - V 2.0

5.3 Handling and Safety Measures

  1. Personal Protective Equipment (PPE):
    • Warehouse personnel must wear appropriate PPE, including gloves, goggles, and masks when handling hazardous liquids.
    • Document PPE compliance in the PPE Compliance Log (Annexure-5).
  2. Spill Response Procedures:
    • In case of liquid spills, immediately contain the spill using absorbent materials and notify the Warehouse Supervisor.
    • Ensure that spill kits are readily available in all liquid storage areas.
    • Document spill incidents in the Spill Incident Log (Annexure-6).

5.4 Monitoring and Inspections

  1. Routine Inspections:
    • Conduct weekly inspections to ensure proper segregation of dry and liquid materials and verify storage conditions.
    • Inspect containers for signs of leakage, damage, or contamination.
    • Document inspection results in the Storage Inspection Log (Annexure-7).
  2. Corrective Actions:
    • Immediately correct any deviations from the segregation protocol.
    • Document corrective actions in the Corrective Action Log (Annexure-8).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment
  • MSDS: Material Safety Data Sheet

7. Documents

  1. Material Classification Log (Annexure-1)
  2. Material Labeling Log (Annexure-2)
  3. Material Storage Log (Annexure-3)
  4. Storage Arrangement Log (Annexure-4)
  5. PPE Compliance Log (Annexure-5)
  6. Spill Incident Log (Annexure-6)
  7. Storage Inspection Log (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
  • OSHA Guidelines for Safe Handling of Chemicals
See also  SOP for Sampling Frequency and Criteria for Raw Materials in Quarantine - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Material Classification Log

Date Material Name Batch Number Classification (Dry/Liquid) Classified By
27/03/2025 Sodium Chloride SC-1234 Dry Ravi Kumar
27/03/2025 Isopropyl Alcohol IPA-5678 Liquid Neha Verma

Annexure-2: Material Labeling Log

Date Material Name Batch Number Label Applied Labeled By
27/03/2025 Sodium Chloride SC-1234 Dry (Blue Label) Amit Joshi
27/03/2025 Isopropyl Alcohol IPA-5678 Liquid (Red Label) Priya Singh

Annexure-3: Material Storage Log

Date Material Name Storage Area Storage Conditions Stored By
27/03/2025 Sodium Chloride Dry Storage Room A Humidity-Controlled, Sealed Ravi Kumar
27/03/2025 Isopropyl Alcohol Liquid Storage Room B Ventilated, Flammable Cabinet Neha Verma

Annexure-4: Storage Arrangement Log

Date Storage Area Arrangement Type Verified By
27/03/2025 Dry Storage Room A Stacked on Pallets Amit Joshi
27/03/2025 Liquid Storage Room B Secondary Containment Trays 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
27/03/2025 2.0 Added Spill Response and Monitoring Procedures Improve Material Safety and Compliance QA Head
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