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SOP for Preventive Maintenance of Manufacturing Equipment

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SOP for Preventive Maintenance of Manufacturing Equipment

Standard Operating Procedure for Preventive Maintenance of Equipment

1) Purpose

The purpose of this SOP is to outline the procedures for performing preventive maintenance on manufacturing equipment to ensure their optimal performance and to prevent unexpected breakdowns.

2) Scope

This SOP applies to all equipment used in the manufacturing of dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Engineering Department is responsible for performing preventive maintenance. The Production Department is responsible for coordinating the maintenance schedule. The Quality Assurance (QA) Department is responsible for verifying and documenting the maintenance activities.

See also  SOP for Mixing and Blending Equipment

4) Procedure

4.1 Preparation

4.1.1 Prepare a preventive maintenance schedule based on the equipment manufacturer’s recommendations and production requirements.

4.1.2 Gather all necessary tools, parts, and maintenance manuals.

4.2 Maintenance Activities

4.2.1 Turn off the equipment and disconnect it from power sources.

4.2.2 Inspect the equipment for signs of wear and tear, leaks, or other issues.

4.2.3 Replace worn or damaged parts according to the manufacturer’s specifications.

4.2.4 Lubricate moving parts as per the manufacturer’s guidelines.

4.2.5 Check and tighten any loose connections and fastenings.

4.3 Documentation

4.3.1 Record all maintenance activities in the preventive maintenance log, including parts replaced and any issues identified.

See also  SOP for Equipment Identification and Labeling

4.3.2 Attach any relevant data, such as calibration certificates or inspection reports, to the maintenance

log.

4.4 Approval

4.4.1 Submit the completed maintenance log to the QA Department for review and approval.

4.4.2 Store the approved maintenance log in the equipment maintenance file.

5) Abbreviations, if any

QA – Quality Assurance6) Documents, if any

Preventive Maintenance Schedule

Equipment Maintenance Log

Manufacturer’s Maintenance Manuals

7) Reference, if any

Current Good Manufacturing Practices (cGMP) 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

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