SOP Guide for Pharma

SOP for Identification of Hazardous Materials

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SOP for Identification of Hazardous Materials

Procedure for Systematic Identification of Hazardous Materials

1) Purpose

The purpose of this SOP is to define a detailed process for identifying hazardous materials at various stages, including procurement, receiving, storage, and usage. Proper identification ensures compliance with safety regulations, prevents accidents, and safeguards personnel and property within the facility.

2) Scope

This SOP applies to all hazardous materials brought into, used, stored, or disposed of within the facility. It covers employees involved in operations, quality assurance, safety, and inventory management.

3) Responsibilities

  • Operators: Handle and identify materials as per this SOP and report discrepancies to the QA team.
  • Quality Assurance (QA): Ensure the correct identification and documentation of hazardous materials.
  • Safety Officers: Monitor compliance with safety regulations and provide necessary training.
  • Inventory Managers: Maintain accurate records of hazardous materials.

4) Procedure

4.1 Classification of Hazardous Materials

  1. Review the SDS:
    1. Obtain the Safety Data Sheet (SDS) from the supplier for all materials procured.
    2. Classify the material into the appropriate category based on its physical and chemical properties:
      • Flammable
      • Corrosive
      • Toxic
      • Reactive
      • Carcinogenic
      • Oxidizer
    3. Record the classification in the Hazardous Material Identification Log.
  2. Check Labels:
    1. Ensure that the supplier’s label includes the following details:
      • Product name and trade name
      • CAS (Chemical Abstracts Service) number
      • Hazard symbol(s)
      • Supplier or manufacturer details
      • Signal words like “Danger” or “Warning”
    2. Inspect containers for any damaged,
missing, or unclear labels and report to the QA team.

4.2 Identification Process for Unknown or Unlabeled Materials

If any hazardous material container lacks proper labeling or its identity is unknown, follow these steps:

  1. Immediately label the container as “Unknown Hazardous Material” and isolate it in a designated area.
  2. Notify the Quality Assurance and Safety team for immediate action.
  3. Testing the Material:
    1. Use non-destructive methods like:
      • Infrared Spectroscopy
      • Gas Chromatography-Mass Spectrometry (GC-MS)
      • pH Testing (for corrosives)
    2. Ensure proper safety measures are followed while performing the tests (e.g., PPE, fume hoods).
  4. Document all test results and findings in the Unknown Material Identification Log (Annexure 2).
  5. Update the SDS records and the hazardous materials inventory once identification is complete.

4.3 Use of Hazard Classification Systems

Implement hazard classification systems as outlined below:

  1. Globally Harmonized System (GHS):
    • Use GHS pictograms to label materials for flammability, toxicity, corrosiveness, and other hazards.
    • Refer to the SDS to confirm the hazard class under GHS guidelines.
  2. Color-Coding System:
    • Apply color codes for quick identification:
      • Red: Flammable
      • Yellow: Reactive
      • Blue: Health Hazard
      • Green: Non-hazardous
    • Ensure that the codes are applied uniformly across the facility.

4.4 Record Management

  1. Maintain a detailed logbook for hazardous materials, including:
    • Material Name
    • CAS Number
    • Hazard Classification
    • Supplier Information
    • Identification Date
  2. Cross-check the logbook monthly for accuracy and update as needed.

5) Abbreviations, if any

  • SDS: Safety Data Sheet
  • GHS: Globally Harmonized System
  • QA: Quality Assurance
  • GC-MS: Gas Chromatography-Mass Spectrometry

6) Documents, if any

  • Safety Data Sheets (SDS)
  • Hazardous Material Identification Log
  • Unknown Material Identification Log

7) Reference, if any

  • OSHA Hazard Communication Standard (29 CFR 1910.1200)
  • Globally Harmonized System (GHS) for Hazard Classification
  • ISO 45001: Occupational Health and Safety Standards

8) SOP Version

Version: 1.0

Annexure

Template 1: Hazardous Material Identification Log
Date Material Name CAS Number Hazard Classification Identified By
DD/MM/YYYY Chemical Name XXXXXXXXX Flammable/Corrosive QA Team Member
         

Template 2: Unknown Material Identification Log
Date Container Label Initial Observation Test Method Used Identified By
DD/MM/YYYY Unknown Appearance, Odor GC-MS/Spectroscopy QA Member
See also  SOP for Managing Waste During Emergency Shutdowns
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