Skip to content
  • Clinical Studies
  • Pharma GMP
  • Pharma Tips
  • Stability Studies
  • Pharma Books
  • Schedule M

SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

  • Home
  • Job Safety Analysis (JSA)
    • Oral Dosage Forms (Tablets & Capsules)
    • Oral Liquid Dosage Forms (Syrups, Elixirs, Suspensions, Emulsions)
    • Powder and Granule Dosage Forms
    • Topical Dosage Forms (Creams, Ointments, Gels, Lotions, Pastes)
    • Transdermal Dosage Forms (Patches)
  • Standard Test Procedures (STP)
  • SOP – Blog Post
  • Toggle search form

SOP for Preparing and Using Safety Data Sheets (SDS)

Posted on By

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

  • Supervisors: Ensure the availability, accuracy, and accessibility of SDS for all hazardous chemicals.
  • Safety Officers: Prepare, review, and update SDS in compliance with regulatory standards.
  • Operators/Employees: Use SDS to understand hazards, PPE requirements, and emergency procedures when handling hazardous chemicals.
  • Procurement Team: Ensure SDS are obtained for all new chemicals purchased.

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.
See also  SOP for Implementation of Renewable Energy in Pharmaceutical Plants

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.
  2. less
    Copy code

  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
  2. less
    Copy code

  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.
See also  SOP for Creating and Archiving EHS Training Modules

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.
  2. less
    Copy code

  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.
See also  SOP for Handling Flooding in Manufacturing Areas

5) Abbreviations, if any

  • SDS: Safety Data Sheet
  • PPE: Personal Protective Equipment
  • GHS: Globally Harmonized System

6) Documents, if any

  • SDS Checklist for New Chemicals
  • SDS Access Log
  • Employee Training Records

7) Reference, if any

  • OSHA Hazard Communication Standard (29 CFR 1910.1200)
  • Globally Harmonized System (GHS) of Classification and Labelling

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
Environment, Health and Safety Tags:Emergency response for hazardous materials incidents, Hazardous materials classification, Hazardous materials compliance audits, Hazardous materials decontamination procedures, Hazardous materials disposal methods, Hazardous materials emergency planning, Hazardous materials emergency response guidebook, Hazardous materials exposure limits, Hazardous materials handling, Hazardous materials handling equipment, Hazardous materials incident command system, Hazardous materials incident reporting, Hazardous materials inventory management, Hazardous materials labeling requirements, Hazardous materials monitoring equipment, Hazardous materials packaging requirements, Hazardous materials placarding requirements, Hazardous materials regulatory agencies, Hazardous materials response team training, Hazardous materials risk assessment, Hazardous materials security plans, Hazardous materials shipping papers, Hazardous materials spill response, Hazardous materials storage guidelines, Hazardous materials training requirements, Hazardous materials transportation regulations, Hazardous materials transportation safety, Personal protective equipment for hazardous materials, Regulatory compliance in hazardous materials management, Safety procedures for hazardous materials

Post navigation

Previous Post: Tablets: SOP for Troubleshooting Capping and Lamination Issues in Tablets – V 2.0
Next Post: Ointments: SOP for Handling Hazardous Materials During Dispensing – V 2.0

Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

Read SOPs in your Language:

 - 
Bengali
 - 
bn
English
 - 
en
Gujarati
 - 
gu
Hindi
 - 
hi
Malayalam
 - 
ml
Marathi
 - 
mr
Punjabi
 - 
pa
Tamil
 - 
ta
Telugu
 - 
te

NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

Copyright © 2025 SOP Guide for Pharma.

Powered by PressBook WordPress theme

Go to mobile version