SOP Guide for Pharma

SOP for Preparing and Using Safety Data Sheets (SDS)

SOP for Preparing and Using Safety Data Sheets (SDS)

Standard Operating Procedure for Preparing and Using Safety Data Sheets (SDS)

1) Purpose

The purpose of this SOP is to outline procedures for preparing, maintaining, and using Safety Data Sheets (SDS) for hazardous materials to ensure compliance with safety regulations and protect personnel from chemical hazards.

2) Scope

This SOP applies to all personnel involved in the preparation, handling, and referencing of Safety Data Sheets for hazardous materials within the facility, including laboratories, production units, and warehouses.

3) Responsibilities

4) Procedure

4.1 Understanding Safety Data Sheets (SDS)

  1. Definition:

    Safety Data Sheets (SDS) are standardized documents that provide detailed information on the properties, hazards, handling, storage, and emergency measures for hazardous chemicals.

  2. Regulatory Requirements:
    • Ensure SDS comply with OSHA Hazard Communication Standard (29 CFR 1910.1200) or GHS (Globally Harmonized System).
    • Each SDS must contain 16 standardized sections as per GHS requirements.

4.2 Obtaining Safety Data Sheets

  1. New Chemicals:
    1. Procurement must request SDS from the supplier or manufacturer when ordering new chemicals.
    2. Verify that the SDS meets the 16-section GHS format before acceptance.
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  3. Existing Chemicals:
    1. Ensure all hazardous chemicals currently in use have an updated SDS.
    2. If SDS are missing or outdated, request updated versions from suppliers immediately.
  4. Storage of SDS:
    1. Maintain printed SDS copies in a designated SDS binder accessible to all personnel in each work area.
    2. Ensure electronic SDS copies are stored in a shared, easily accessible location with proper backups.

4.3 Structure of Safety Data Sheets

Ensure all SDS are prepared in accordance with the 16-section format under GHS guidelines:

  1. Section 1: Identification
    • Product identifier (chemical name, CAS number)
    • Supplier details (name, address, contact)
    • Recommended uses and restrictions
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  3. Section 2: Hazard Identification
    • GHS classification of hazards
    • Hazard statements, precautionary statements, and pictograms
  4. Section 3: Composition/Information on Ingredients
    • List of hazardous ingredients with CAS numbers
    • Concentration percentages
  5. Section 4: First-Aid Measures
    • Emergency procedures for skin, eye, inhalation, and ingestion exposure
  6. Section 5: Fire-Fighting Measures
    • Suitable extinguishing media
    • Special protective equipment for firefighters
  7. Section 6: Accidental Release Measures
    • Procedures for containment, cleanup, and environmental precautions
  8. Section 7: Handling and Storage
    • Safe handling guidelines and storage requirements
  9. Section 8: Exposure Controls/PPE
    • Exposure limits (OSHA, ACGIH)
    • Required PPE (gloves, goggles, respirators)
  10. Section 9: Physical and Chemical Properties
    • Appearance, odor, pH, boiling point, etc.
  11. Section 10: Stability and Reactivity
    • Reactivity hazards and incompatible materials
  12. Section 11: Toxicological Information
    • Health effects, exposure symptoms, and toxicity data
  13. Section 12-16: Environmental, disposal, transport, and regulatory information.

4.4 Using Safety Data Sheets

  1. Employee Training:
    1. Train all personnel on how to locate, read, and use SDS effectively.
    2. Provide refresher training annually and after introducing new chemicals.
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  3. Referencing SDS Before Tasks:
    1. Before handling any hazardous chemical, employees must:
      • Read Sections 2 (Hazards), 8 (PPE), and 4 (First Aid) of the SDS.
      • Follow recommended control measures and PPE usage.
    2. Review disposal instructions in Section 13 before chemical waste handling.
  4. Emergency Situations:
    1. Use SDS during spills, leaks, or exposures to guide immediate response actions.
    2. Provide SDS to emergency responders for effective hazard mitigation.

4.5 SDS Review and Updates

  1. Review SDS annually or whenever new information is provided by the manufacturer.
  2. Update SDS to reflect changes in chemical composition, usage, or regulations.
  3. Replace outdated versions and ensure personnel are notified of changes.

5) Abbreviations, if any

6) Documents, if any

7) Reference, if any

8) SOP Version

Version: 1.0

Annexure

Template 1: SDS Checklist for New Chemicals

 
Chemical Name SDS Received (Yes/No) Date of SDS Reviewed By Comments
Chemical A Yes DD/MM/YYYY Safety Officer Approved

Template 2: SDS Access Log

 
Date Chemical Name Accessed By Purpose Comments
DD/MM/YYYY Chemical A John Doe Spill Response Reviewed SDS for cleanup
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