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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Author: Auditor

SOP for Utilities Management in Manufacturing

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SOP for Utilities Management in Manufacturing Standard Operating Procedure for Utilities Management in Manufacturing 1) Purpose The purpose of this SOP is to establish procedures for managing utilities in the manufacturing of dental dosage forms, ensuring the availability, reliability, and compliance of utilities such as electricity, water, HVAC, and compressed air to support continuous production…

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Dental Dosage Forms

SOP for Liquid Filling Machine

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SOP for Liquid Filling Machine Standard Operating Procedure for Using Liquid Filling Machine 1) Purpose The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the liquid filling machine used in the manufacturing of otic dosage forms to ensure accurate and consistent filling of liquid products. 2) Scope…

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Otic (Ear) Dosage Forms

SOP for Sterilization Line for Ointments

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SOP for Sterilization Line for Ointments Standard Operating Procedure for Sterilization Line for Ointments in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for the operation, cleaning, and maintenance of the sterilization line specifically designed for ointments, ensuring efficient and compliant production practices. 2) Scope This…

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Ocular (Eye) Dosage Forms

SOP for Equipment Spare Parts Management

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SOP for Equipment Spare Parts Management Standard Operating Procedure for Equipment Spare Parts Management 1) Purpose The purpose of this SOP is to establish procedures for the management of spare parts for equipment used in the manufacturing of dental dosage forms, ensuring the availability of necessary parts to minimize downtime and maintain continuous production. 2)…

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Dental Dosage Forms

SOP for Change Management

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SOP for Change Management Standard Operating Procedure for Change Management 1) Purpose The purpose of this SOP is to establish procedures for the management of changes to facilities, equipment, materials, processes, and documentation to ensure controlled and effective change management within the manufacturing facility. 2) Scope This SOP applies to all departments and functions within…

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Rectal Dosage Forms

SOP for Vacuum Oven

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SOP for Vacuum Oven Standard Operating Procedure for Using Vacuum Oven 1) Purpose The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the vacuum oven used in the manufacturing of otic dosage forms to ensure effective drying and degassing under controlled conditions. 2) Scope This SOP applies…

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Otic (Ear) Dosage Forms

SOP for Sterilization Line for Eye Drops

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SOP for Sterilization Line for Eye Drops Standard Operating Procedure for Sterilization Line for Eye Drops in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for the operation, cleaning, and maintenance of the sterilization line specifically designed for eye drops, ensuring efficient and compliant production practices….

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Ocular (Eye) Dosage Forms

SOP for Handling Equipment Failures and Deviations

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SOP for Handling Equipment Failures and Deviations Standard Operating Procedure for Handling Equipment Failures and Deviations 1) Purpose The purpose of this SOP is to establish a systematic approach for handling equipment failures and deviations in the manufacturing of dental dosage forms, ensuring timely identification, documentation, and resolution to maintain product quality and compliance with…

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Dental Dosage Forms

SOP for Sealing Line for Inserts

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SOP for Sealing Line for Inserts Standard Operating Procedure for Sealing Line for Inserts in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for the operation, cleaning, and maintenance of the sealing line specifically designed for inserts, ensuring efficient and compliant production practices. 2) Scope This…

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Ocular (Eye) Dosage Forms

SOP for Double Cone Blender

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SOP for Double Cone Blender Standard Operating Procedure for Using Double Cone Blender 1) Purpose The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the double cone blender used in the manufacturing of otic dosage forms to ensure uniform blending of ingredients. 2) Scope This SOP applies…

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Otic (Ear) Dosage Forms

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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
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Capsules V 2.0
  • Creams 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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