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Injectables: SOP for Personal Protective Equipment (PPE) Usage

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SOP for Personal Protective Equipment (PPE) Usage

Standard Operating Procedure for Personal Protective Equipment (PPE) Usage

1) Purpose

The purpose of this SOP is to establish procedures for the selection, use, and maintenance of personal protective equipment (PPE) to ensure the safety and health of personnel working in pharmaceutical manufacturing areas.

2) Scope

This SOP applies to all personnel required to wear PPE within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Employees

  • Wear appropriate PPE as required by job tasks and risk assessments.
  • Inspect and maintain PPE in good condition.

3.2 Safety Officer

  • Conduct PPE assessments and recommend appropriate PPE based on job hazards.
  • Monitor PPE compliance and provide training as necessary.
See also  SOP for Handling of Hazardous Materials

4) Procedure

4.1 PPE Selection

  1. Identify hazards and assess risks to determine PPE requirements.
  2. Select appropriate PPE (e.g., gloves, goggles, respirators) based on hazard assessment.

4.2 PPE Use

  1. Wear PPE correctly and consistently during designated activities.
  2. Replace PPE that is damaged or worn out immediately.

4.3 Maintenance and Storage

  1. Clean and sanitize reusable PPE after each use.
  2. Store PPE in designated areas away from contaminants and environmental hazards.

4.4 Training and Awareness

  1. Provide training on proper PPE use, maintenance, and limitations.
  2. Ensure employees understand the importance of PPE in preventing workplace injuries and illnesses.

5) Abbreviations, if any

PPE: Personal Protective Equipment

See also  SOP for Emulsion Stability Testing

6) Documents, if any

  • PPE Assessment Records
  • Training Certificates
  • PPE Inspection and Maintenance Logs

7) Reference, if any

OSHA

29 CFR 1910.132: General requirements for personal protective equipment
CDC Guidance for PPE in Healthcare Settings

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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