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SOP for Handling of Hazardous Materials

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SOP for Handling of Hazardous Materials

Standard Operating Procedure for Handling of Hazardous Materials

1) Purpose

The purpose of this SOP is to establish safe and standardized procedures for the handling, storage, and disposal of hazardous materials in the manufacturing environment to ensure the safety of personnel and compliance with regulatory requirements.

2) Scope

This SOP applies to all employees who handle hazardous materials within the manufacturing facility, including but not limited to raw materials, intermediates, and finished products that are classified as hazardous.

3) Responsibilities

3.1 Safety Officer
– Ensure compliance with all regulatory requirements regarding hazardous materials.
– Provide training and resources to employees for safe handling of hazardous materials.
3.2 Manufacturing Personnel
Follow all procedures outlined in this SOP when handling hazardous materials.
Use appropriate personal protective equipment (PPE) and adhere to safety protocols.
3.3 Quality Assurance
Conduct regular audits to ensure adherence to this SOP.
Maintain documentation related to the handling of hazardous materials.

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4) Procedure

4.1 Identification and Classification
4.1.1 Identify hazardous materials using Safety Data Sheets (SDS) and product labels.
4.1.2 Classify materials based on hazard categories (e.g., flammable, toxic, corrosive).
4.2 Personal Protective Equipment (PPE)
4.2.1 Determine appropriate PPE for each hazardous material as specified in the SDS.
4.2.2 Ensure availability of

PPE, such as gloves, goggles, face shields, and respirators.
4.3 Handling Procedures
4.3.1 Follow specific handling instructions provided in the SDS.
4.3.2 Avoid direct contact with hazardous materials by using tools and equipment.
4.4 Storage
4.4.1 Store hazardous materials in designated areas with proper labeling.
4.4.2 Ensure storage areas are well-ventilated and away from incompatible materials.
4.5 Spill and Leak Response
4.5.1 Contain and clean spills immediately using appropriate spill kits.
4.5.2 Report all spills to the Safety Officer and document the incident.
4.6 Disposal
4.6.1 Dispose of hazardous waste in accordance with local, state, and federal regulations.
4.6.2 Use designated hazardous waste containers and ensure they are properly labeled.

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5) Abbreviations, if any

– PPE: Personal Protective Equipment
– SDS: Safety Data Sheet

6) Documents, if any

– Safety Data Sheets (SDS)
– Hazardous Materials Inventory Log
– Spill Incident Report Form

7) Reference, if any

– Occupational Safety and Health Administration (OSHA) Hazard Communication Standard
– Environmental Protection Agency (EPA) regulations on hazardous waste

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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