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Quality Assurance: SOP for Energy Control Procedures in Gels Production

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SOP for Energy Control Procedures in Gels Production

Standard Operating Procedure for Energy Control Procedures in Gels Production

1) Purpose

The purpose of this SOP is to establish procedures for the control of energy sources during maintenance, servicing, and cleaning of equipment in gels production to prevent accidents, injuries, and equipment damage.

2) Scope

This SOP applies to all personnel involved in operating, maintaining, servicing, and cleaning equipment used in gels production within the pharmaceutical manufacturing facility.

3) Responsibilities

Production Operators: Follow energy control procedures during equipment operation and maintenance.
Maintenance Technicians: Perform lockout/tagout procedures and verify equipment isolation.
Supervisors: Ensure compliance with energy control procedures and provide oversight during maintenance activities.
Health and Safety Officers: Monitor and enforce safety regulations related to energy control.

See also  SOP for Electronic Records and Signatures

4) Procedure

4.1 Energy Control Program
4.1.1 Develop and maintain an energy control program that complies with regulatory requirements and company policies.
4.1.2 Identify all energy sources (electrical, mechanical, hydraulic, pneumatic, etc.) that need to be controlled.

4.2 Lockout/Tagout Procedures
4.2.1 Obtain authorization and a work permit before starting any maintenance or cleaning activities.
4.2.2 Notify affected personnel about the equipment shutdown and lockout/tagout procedures.
4.2.3 Isolate energy sources by placing lockout devices and tags

on appropriate switches, valves, or controls.

4.3 Verification of Isolation
4.3.1 Verify that all energy sources are effectively isolated and equipment is in a zero-energy state before beginning work.
4.3.2 Test equipment controls to ensure they are inoperative and cannot be started accidentally.

See also  SOP for Elemental Impurity Testing

4.4 Work Activities
4.4.1 Perform maintenance, servicing, or cleaning activities as per approved procedures and work instructions.
4.4.2 Use appropriate tools and equipment in accordance with safety guidelines.

4.5 Release of Lockout/Tagout
4.5.1 After completing work, remove lockout/tagout devices only by authorized personnel.
4.5.2 Verify with affected personnel that work is complete and equipment is safe to operate.

4.6 Training and Communication
4.6.1 Provide training to personnel on energy control procedures, including lockout/tagout techniques and safety measures.
4.6.2 Maintain clear communication between operators, maintenance technicians, and supervisors throughout the process.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

– Energy Control Program Documentation
– Lockout/Tagout Procedures
– Work Permits

See also  SOP for HEPA Filter Integrity Testing

7) Reference, if any

– OSHA 29 CFR 1910.147: Control of Hazardous Energy (Lockout/Tagout)
– ANSI/ASSE Z244.1: Control of Hazardous Energy – Lockout/Tagout and Alternative Methods
– Company-specific safety guidelines and procedures

8) SOP Version

Version 1.0

Quality Assurance Tags:Analytical Method Development for Gels, Assay of Active Ingredient in Gels, Cleaning Equipment for Gel Production, Contamination Prevention in Gel Manufacturing, Equipment Calibration for Gel Manufacturing, Final Product Inspection for Gels, Gel Formulation Development, Gel Homogeneity Testing, Gel Labeling Procedures, Gel Preparation SOP, Gel Production Documentation, Gel Production Waste Disposal, Gel Quality Control Testing, Gel Viscosity Testing, In-process Testing for Gels, Microbial Testing of Gels, Packaging of Gels, Particle Size Analysis in Gels, Particle Size Distribution in Gels, pH Testing of Gels, Pharmaceutical Gel Manufacturing, Process Optimization for Gel Manufacturing, Process Validation for Gels, Raw Material Inspection for Gels, Rheological Testing in Gels, Sample Collection for Gel Quality Testing, Stability Testing for Gels, Sterility in Gel Production, Storage Conditions for Gels, Training for Gel Production Personnel

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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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