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SOP Guide for Pharma

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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 guidelines for the proper selection, use, and maintenance of personal protective equipment (PPE) to ensure personnel safety during pharmaceutical manufacturing operations.

2) Scope

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

3) Responsibilities

3.1 Employees

  • Properly wear and maintain assigned PPE.
  • Report any PPE defects or concerns to supervisors.

3.2 Safety Officers

  • Provide training on PPE selection, use, and maintenance.
  • Ensure compliance with PPE requirements through regular inspections.
See also  SOP for Validation of FFS Machine Process

4) Procedure

4.1 PPE Selection

  1. Identify hazards associated with specific tasks and areas.
  2. Select appropriate PPE based on identified hazards (e.g., gloves, goggles, masks).

4.2 PPE Use

  1. Wear PPE correctly and consistently during designated tasks.
  2. Replace damaged or soiled PPE immediately.

4.3 PPE Maintenance

  1. Clean and sanitize reusable PPE after each use.
  2. Inspect PPE regularly for signs of wear and tear; replace as needed.

4.4 Training and Awareness

  1. Provide initial and refresher training on PPE use and safety protocols.
  2. Post signage and communicate PPE requirements in designated areas.

5) Abbreviations, if any

SOP: Standard Operating Procedure; PPE: Personal Protective Equipment

See also  Injectables: SOP for Process Validation

6) Documents, if any

  • PPE Selection Matrix
  • Training Records
  • PPE Inspection and Maintenance Log

7) Reference, if any

OSHA 29 CFR 1910.132: Personal Protective Equipment
CDC Guidelines for Personal

Protective Equipment in Healthcare Settings

8) SOP Version

Version 1.0

Injectables Tags:Analytical method validation for injections, Aseptic media fill trials SOP, Bioburden testing for injections, Cleaning validation for injection equipment, Emulsion stability testing for injections, Formulation development for injections, Homogeneity testing for injections, IM injection SOP, Injection filling volume accuracy, Injection stability testing, Intramuscular injection procedure, Intravenous injection guidelines, IV injection SOP, Needle assembly for syringes SOP, Packaging integrity testing for injections, Particle size analysis for injections, Pre-filled syringe stability testing, Product sterility in aseptic processing, Reconstitution testing for injections, SC injection SOP, Subcutaneous injection technique, Syringe filling and capping SOP, Syringe labeling and inspection SOP, Temperature mapping in storage areas, Viscosity testing for injections

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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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