SOP Guide for Pharma

SOP for Managing Hazardous Material Inventory

Auditor

SOP for Managing Hazardous Material Inventory

Standard Operating Procedure for Managing Hazardous Material Inventory

1) Purpose

The purpose of this SOP is to provide guidelines for the accurate tracking, monitoring, and management of hazardous material inventory to ensure safety, compliance with regulations, and effective control of material usage within the facility.

2) Scope

This SOP applies to all hazardous materials used, stored, and transported within the facility, including chemicals, flammable substances, corrosives, reactive materials, and toxic agents.

3) Responsibilities

  • Inventory Managers: Maintain updated inventory records, ensure labeling accuracy, and report discrepancies.
  • Operators: Record all material usage and report low stock levels or damaged containers immediately.
  • Supervisors: Verify inventory records and compliance with storage requirements during inspections.
  • Safety Officers: Oversee hazardous material inventory audits and ensure regulatory compliance.

4) Procedure

4.1 Hazardous Material Identification

  1. Material Classification:
    1. Classify hazardous materials into categories, including:
      • Flammable liquids and gases
      • Corrosive substances
      • Oxidizers and reactive chemicals
      • Toxic or poisonous materials
      • Compressed gases
    2. Refer to Safety Data Sheets (SDS) to confirm hazard classification and storage requirements.
  2. Material Labeling:
    1. Ensure that all containers are labeled clearly with:
      • Material name
      • Hazard classification symbols
      • Date of receipt and expiration (if applicable)
      • Storage location
    2. Replace missing or damaged labels immediately.
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4.2 Inventory Recordkeeping

  1. Inventory Log:
    1. Maintain a detailed Hazardous Material Inventory Log (Annexure 1), recording the following information:
      • Material name and chemical formula
      • Quantity received and quantity
in stock
  • Location of storage
  • Supplier name and date of receipt
  • Material usage logs and disposal records
  • Update inventory logs whenever materials are received, dispensed, or disposed of.

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  • Digital Tracking Systems:
    1. Utilize electronic inventory management software to:
      • Track real-time inventory levels
      • Set automatic alerts for low stock or expired materials
      • Maintain historical records for audits
    2. Assign user access to authorized personnel only.

    • 4.3 Receiving and Updating Inventory

    1. Receiving Hazardous Materials:
      1. Verify received materials against purchase orders for:
        • Correct material name and quantity
        • Proper labeling and condition of containers
      2. Inspect containers for leaks, damage, or missing labels before acceptance.

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    2. Updating Inventory Records:
      1. Log received materials into the Hazardous Material Inventory Log with accurate details.
      2. Update digital tracking systems with current stock levels and storage locations.

    4.4 Monitoring and Auditing Inventory

    1. Daily Checks:
      1. Verify the accuracy of material usage records by comparing physical stock with inventory logs.
      2. Check for damaged, leaking, or improperly stored materials.

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    2. Weekly Inspections:
      1. Conduct weekly inventory audits to identify:
        • Discrepancies in stock levels
        • Expired or near-expiry materials
        • Non-compliance with storage guidelines
      2. Record inspection findings in the Inventory Inspection Log (Annexure 2).
    3. Monthly Audits:
      1. Perform detailed audits of hazardous material inventory with assistance from the QA and Safety Officers.
      2. Document any corrective actions and verify their completion.

    4.5 Disposal of Expired or Excess Materials

    1. Identification of Expired Materials:
      1. Flag expired, near-expiry, or excess hazardous materials during inspections.

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    2. Disposal Process:
      1. Follow approved hazardous waste disposal guidelines for specific material types.
      2. Document disposal details, including:
        • Material name
        • Quantity disposed
        • Date of disposal
        • Method of disposal
      3. Update inventory logs to reflect disposal actions.

    4.6 Training and Compliance

    1. Train personnel on proper inventory management, including:
      • Updating records
      • Handling damaged or leaking containers
      • Identifying and flagging expired materials
    2. Conduct refresher training annually or after significant incidents.

    5) Abbreviations, if any

    • SDS: Safety Data Sheet
    • QA: Quality Assurance

    6) Documents, if any

    • Hazardous Material Inventory Log
    • Inventory Inspection Log
    • Hazardous Material Disposal Records

    7) Reference, if any

    • OSHA Hazard Communication Standard (29 CFR 1910.1200)
    • EPA Hazardous Waste Management Guidelines

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Hazardous Material Inventory Log
    Material Name Quantity Location Date Received Expiration Date Handled By
    Material Name XX Liters/Kg Storage Area 1 DD/MM/YYYY DD/MM/YYYY Employee Name

    Template 2: Inventory Inspection Log
    Date Location Inspection Parameter Observations Corrective Actions Inspector
    DD/MM/YYYY Storage Area 2 Expired Material Identified 5 expired containers Disposed of as per SOP Inspector Name
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