SOP Guide for Pharma

SOP for Classification of Hazardous Chemicals

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SOP for Classification of Hazardous Chemicals

Procedure for Classification of Hazardous Chemicals

1) Purpose

The purpose of this SOP is to outline a structured process for the classification of hazardous chemicals to ensure compliance with safety regulations, accurate risk assessment, and appropriate hazard communication.

2) Scope

This SOP applies to all hazardous chemicals received, used, stored, or transported within the facility. It includes classification based on physical, health, and environmental hazards as per regulatory standards.

3) Responsibilities

  • Operators: Identify and report the hazard classification of chemicals during receiving and handling.
  • Quality Assurance (QA): Verify and approve the classification of hazardous chemicals.
  • Safety Officers: Ensure compliance with classification guidelines and provide training as necessary.
  • Inventory Managers: Maintain updated records of classified chemicals.

4) Procedure

4.1 Overview of Hazard Classification Systems

  1. Adopt Globally Harmonized System (GHS):
    1. The GHS classifies chemicals into three main hazard categories:
      • Physical Hazards: Flammable, reactive, explosive, oxidizers, etc.
      • Health Hazards: Toxicity, carcinogenicity, respiratory sensitizers, skin corrosion, etc.
      • Environmental Hazards: Aquatic toxicity, ozone depletion, etc.
    2. Ensure proper GHS labeling, including signal words, hazard symbols, and precautionary statements.
  2. Refer to Regulatory Guidelines:
    1. Use OSHA Hazard Communication Standard (29 CFR 1910.1200) for U.S.-based operations.
    2. Follow national or international guidelines applicable to your facility (e.g., European CLP regulation, UN standards).
See also  SOP for Disposal of Hazardous Materials in Lab Environments

4.2 Steps for Classifying Hazardous Chemicals

  1. Obtain the Safety Data Sheet
(SDS):
  1. Collect the SDS for each chemical from the supplier.
  2. Identify key sections in the SDS:
    • Section 2: Hazard Identification
    • Section 9: Physical and Chemical Properties
    • Section 11: Toxicological Information
    • Section 12: Ecological Information
  • Classify Based on Hazard Properties:
    1. Physical Hazards:
      • Test for flammability (flash point, auto-ignition).
      • Identify explosive or reactive properties.
      • Evaluate oxidizing potential through chemical composition.
    2. Health Hazards:
      • Review toxicology data for acute or chronic effects.
      • Identify skin, eye, or respiratory irritants.
      • Classify carcinogenic, mutagenic, or teratogenic properties.
    3. Environmental Hazards:
      • Assess potential for aquatic toxicity through testing.
      • Identify chemicals contributing to ozone layer depletion.
  • Cross-Verify Hazard Categories:
    1. Use GHS charts and regulatory guidelines to verify classification accuracy.
    2. Consult safety officers for any discrepancies or unclear classifications.
  • Label and Record the Classification:
    1. Label the chemical container with:
      • Signal word: “Danger” or “Warning.”
      • Hazard pictograms (as per GHS).
      • Hazard and precautionary statements.
    2. Update the Hazardous Chemical Classification Log (Annexure 1).

    • 4.3 Review and Audit

    1. QA and safety officers must conduct monthly reviews of hazardous chemical classifications.
    2. Perform audits of SDS records to ensure compliance and identify any missing information.
    3. Update classifications whenever new information becomes available or regulatory changes occur.

    4.4 Training

    1. Conduct training sessions for personnel on:
      • Understanding GHS hazard classifications.
      • Reading and interpreting SDS and labels.
      • Using classification logs and maintaining records.
    2. Ensure training records are maintained for future reference.

    5) Abbreviations, if any

    • SDS: Safety Data Sheet
    • GHS: Globally Harmonized System
    • QA: Quality Assurance
    • OSHA: Occupational Safety and Health Administration

    6) Documents, if any

    • Safety Data Sheets (SDS)
    • Hazardous Chemical Classification Log

    7) Reference, if any

    • OSHA Hazard Communication Standard (29 CFR 1910.1200)
    • GHS Classification and Labeling Guidelines
    • ISO 11014-1: Safety Data Sheet Standard

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Hazardous Chemical Classification Log
    Date Chemical Name CAS Number Hazard Classification Classified By
    DD/MM/YYYY Chemical Name XXXXXXXX Flammable/Corrosive/Toxic QA Officer
             
    See also  SOP for Maintaining Maintenance Records for Safety Equipment
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