SOP for Handling and Storage of Liquid Raw Materials in Bulk Containers – V 2.0

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SOP for Handling and Storage of Liquid Raw Materials in Bulk Containers – V 2.0

Standard Operating Procedure for Handling and Storage of Liquid Raw Materials in Bulk Containers

Department Warehouse / Quality Assurance
SOP No. SOP/RM/134/2025
Supersedes SOP/RM/134/2022
Page No. Page 1 of 15
Issue Date 28/02/2025
Effective Date 05/03/2025
Review Date 28/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the guidelines for the safe handling and storage of liquid raw materials in bulk containers, ensuring product integrity, safety, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all liquid raw materials received, handled, and stored in bulk containers, including solvents, oils, and chemicals, within the warehouse facility.

3. Responsibilities

  • Warehouse Personnel: Responsible for the safe receipt, handling, and storage of bulk liquid raw materials according to this SOP.
  • Warehouse Manager: Supervise handling and storage procedures and ensure compliance with safety and GMP guidelines.
  • Quality Assurance (QA): Verify that materials are handled and stored properly and that records are maintained accurately.
  • Safety Officer: Ensure that handling procedures meet safety standards and that appropriate personal protective equipment (PPE) is used.

4. Accountability

The Warehouse Manager is accountable for the correct handling and storage of liquid raw materials in bulk containers. The QA Manager is responsible for verifying compliance with GMP and safety regulations.

5. Procedure

5.1 Receiving and Inspection of Bulk Liquid Raw Materials

  1. Inspection at Receipt:
    • Inspect bulk containers for visible signs of damage, leaks, or contamination upon arrival.
    • Verify container integrity, including seals, valves, and labeling.
    • Cross-check material documentation (Certificate of Analysis, Material Safety Data Sheet) with the purchase order.
    • Document receipt and inspection in the Bulk Liquid Receiving Log (Annexure-1).
  2. Verification of Documentation:
    • Ensure that all required documentation, including batch numbers and expiry dates, is accurate and complete.
    • Record document verification in the Documentation Verification Log (Annexure-2).
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5.2 Handling Procedures for Bulk Liquid Raw Materials

  1. Use of Handling Equipment:
    • Use forklifts, drum handlers, or pallet jacks for moving heavy bulk containers.
    • Ensure equipment is in good working condition and regularly maintained.
    • Document equipment usage in the Handling Equipment Log (Annexure-3).
  2. Manual Handling:
    • When manual handling is necessary, ensure at least two trained personnel are involved.
    • Use proper lifting techniques and PPE, including gloves, safety goggles, and protective clothing.
    • Document manual handling activities in the Manual Handling Log (Annexure-4).

5.3 Storage of Bulk Liquid Raw Materials

  1. Storage Conditions:
    • Store bulk containers upright on pallets to prevent leaks and ensure stability.
    • Ensure storage areas are well-ventilated and free from direct sunlight and heat sources.
    • Document storage conditions in the Storage Condition Log (Annexure-5).
  2. Segregation and Labeling:
    • Segregate materials based on their chemical nature (flammable, corrosive, etc.) and store in designated areas.
    • Ensure all containers are properly labeled with material name, batch number, expiry date, and hazard warnings.
    • Record segregation and labeling in the Segregation and Labeling Log (Annexure-6).

5.4 Spill Prevention and Emergency Procedures

  1. Spill Prevention Measures:
    • Inspect storage areas regularly for signs of leaks or spills.
    • Ensure spill containment kits are available and easily accessible in storage areas.
    • Document spill prevention inspections in the Spill Prevention Log (Annexure-7).
  2. Emergency Spill Response:
    • In the event of a spill, immediately contain the spill using appropriate absorbent materials and notify the Safety Officer.
    • Follow emergency response protocols as outlined in the Material Safety Data Sheet (MSDS).
    • Document spill incidents and responses in the Spill Incident Log (Annexure-8).
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5.5 Handling Deviations and Corrective Actions

  1. Reporting Deviations:
    • Report any deviations, such as improper storage conditions or handling errors, to the Warehouse Manager and QA.
    • Document deviations in the Deviation Log (Annexure-9).
  2. Corrective Actions:
    • Investigate the cause of deviations and implement corrective measures, such as retraining personnel or updating procedures.
    • Document corrective actions in the Corrective Action Log (Annexure-10).

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. Bulk Liquid Receiving Log (Annexure-1)
  2. Documentation Verification Log (Annexure-2)
  3. Handling Equipment Log (Annexure-3)
  4. Manual Handling Log (Annexure-4)
  5. Storage Condition Log (Annexure-5)
  6. Segregation and Labeling Log (Annexure-6)
  7. Spill Prevention Log (Annexure-7)
  8. Spill Incident Log (Annexure-8)
  9. Deviation Log (Annexure-9)
  10. Corrective Action Log (Annexure-10)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO GMP Guidelines
  • OSHA Hazardous Materials Handling Standards

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Bulk Liquid Receiving Log

Date Material Name Batch Number Container Condition Inspected By
28/02/2025 Solvent A Batch1234 No Damage Ravi Kumar
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Annexure-2: Documentation Verification Log

Date Material Name Document Verified Verified By
28/02/2025 Solvent A COA, MSDS Sunita Sharma

Annexure-3: Handling Equipment Log

Date Equipment Used Material Handled Handled By
28/02/2025 Forklift Solvent A Amit Joshi

Annexure-4: Manual Handling Log

Date Material Name Batch Number Handled By
28/02/2025 Solvent B Batch5678 Neha Verma

Annexure-5: Storage Condition Log

Date Material Name Storage Temperature Storage Location
28/02/2025 Solvent A 25°C Warehouse A – Shelf 5

Annexure-6: Segregation and Labeling Log

Date Material Name Label Applied By Segregation Area
28/02/2025 Solvent A Priya Singh Flammable Materials Section

Annexure-7: Spill Prevention Log

Date Inspection Performed By Findings Corrective Actions Taken
28/02/2025 Ravi Kumar No leaks found N/A

Annexure-8: Spill Incident Log

Date Material Name Spill Description Response Action Reported By
28/02/2025 Solvent A Minor spill during transfer Contained with absorbent pads Sunita Sharma

Annexure-9: Deviation Log

Date Deviation Description Reported By Corrective Action Taken
28/02/2025 Improper labeling of solvent container Amit Joshi Relabeled correctly

Annexure-10: Corrective Action Log

Date Corrective Action Description Implemented By Verified By
01/03/2025 Retraining on proper labeling procedures Rajeev Menon QA Head – Priya Singh

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
28/02/2025 2.0 Updated Procedures for Handling Bulk Liquids Regulatory Compliance QA Head
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