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SOP for Safety Data Sheet (SDS) Management for Aerosols

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SOP for Safety Data Sheet (SDS) Management for Aerosols

Standard Operating Procedure for Safety Data Sheet (SDS) Management for Aerosols

1) Purpose

The purpose of this SOP is to outline procedures for the management and maintenance of Safety Data Sheets (SDS) for aerosol products to ensure compliance with safety regulations and provide essential information for safe handling and use.

2) Scope

This SOP applies to the creation, revision, distribution, and archival of SDS documents for aerosol products manufactured and handled at [Company Name].

3) Responsibilities

Environmental Health and Safety (EHS) Department: Manage SDS creation, updates, and distribution.
Regulatory Affairs: Ensure compliance with regulatory requirements related to SDS.
Production and Quality Assurance Teams: Provide accurate product information for SDS creation.
Employees: Follow SDS guidelines for safe handling, storage, and disposal of aerosol products.

See also  SOP for Homogeneity Testing in Aerosols

4) Procedure

4.1 SDS Creation and Revision:
4.1.1 Gather information on aerosol product ingredients, hazards, handling instructions, and emergency measures.
4.1.2 Create initial SDS for new aerosol products or revise existing SDS as necessary based on product updates or regulatory changes.
4.1.3 Ensure SDS content complies with regulatory standards (e.g., OSHA Hazard Communication Standard, GHS requirements).

4.2 SDS Distribution:
4.2.1 Distribute SDS to relevant departments (e.g., production, shipping, sales) and customers as required by regulations.
4.2.2 Provide access to SDS electronically or in hard copy format as per employee and customer needs.
4.2.3 Maintain records of SDS distribution to ensure all required parties receive current and accurate information.

See also  SOP for Light Exposure Testing for Aerosols

4.3 SDS Review and Update:
4.3.1 Regularly review SDS for accuracy and completeness, updating as necessary to reflect changes in product composition or safety information.
4.3.2 Document SDS revisions and ensure timely dissemination of updated versions to affected departments and stakeholders.
4.3.3 Archive previous versions of SDS for historical reference and regulatory compliance purposes.

4.4 Emergency Response Planning:
4.4.1 Incorporate SDS information into emergency response plans and training programs for handling aerosol product emergencies.
4.4.2 Conduct regular drills and training sessions to ensure employees understand SDS information and emergency procedures.
4.4.3 Update SDS and emergency response plans based on lessons learned from drills and real-life incidents.

See also  SOP for Final Product Inspection for Aerosols

4.5 Compliance Documentation:
4.5.1 Maintain records of SDS creation, distribution, updates, and employee training.
4.5.2 Ensure SDS management practices align with regulatory requirements and company policies.
4.5.3 Prepare for audits and inspections by keeping SDS documentation organized and accessible.

5) Abbreviations, if any

SOP: Standard Operating Procedure
SDS: Safety Data Sheet
EHS: Environmental Health and Safety
GHS: Globally Harmonized System of Classification and Labelling of Chemicals

6) Documents, if any

Current SDS for Aerosol Products
SDS Distribution Records
SDS Revision History
Employee Training Records

7) Reference, if any

OSHA Hazard Communication Standard (29 CFR 1910.1200)
GHS Classification Criteria
Company-Specific SDS Templates and Guidelines

8) SOP Version

Version 1.0

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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

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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.

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