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

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 Safe Handling of Hazardous Substances

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
  2. 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.
  3. 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.
  4. 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).
See also  SOP for Documenting Routine EHS Audits

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

6) Documents, if any

See also  SOP for Preparing and Using Safety Data Sheets (SDS)

7) Reference, if any

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
         
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