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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 Handling Deviations

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SOP for Handling Deviations Standard Operating Procedure for Handling Deviations 1) Purpose The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of deviations from established processes or procedures to ensure product quality, compliance, and continuous improvement. 2) Scope This SOP applies to all departments and processes within the…

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Rectal Dosage Forms

SOP for Sealing Line for Gels

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SOP for Sealing Line for Gels Standard Operating Procedure for Sealing Line for Gels 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 gels, ensuring efficient and compliant production practices. 2) Scope This…

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Ocular (Eye) Dosage Forms

SOP for Calibration of Measuring Instruments

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SOP for Calibration of Measuring Instruments Standard Operating Procedure for Calibration of Measuring Instruments 1) Purpose The purpose of this SOP is to establish procedures for the calibration of measuring instruments used in the manufacturing of dental dosage forms, ensuring that all instruments provide accurate and reliable measurements necessary for maintaining product quality and regulatory…

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Dental Dosage Forms

SOP for Sterilization Tunnel

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SOP for Sterilization Tunnel Standard Operating Procedure for Using Sterilization Tunnel 1) Purpose The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the sterilization tunnel used in the manufacturing of otic dosage forms to ensure effective sterilization of containers and closures. 2) Scope This SOP applies to…

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Otic (Ear) Dosage Forms

SOP for Sealing Line for Ointments

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SOP for Sealing Line for Ointments Standard Operating Procedure for Sealing 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 sealing 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 Cleaning Agents and Disinfectants

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SOP for Equipment Cleaning Agents and Disinfectants Standard Operating Procedure for Equipment Cleaning Agents and Disinfectants 1) Purpose The purpose of this SOP is to establish procedures for the selection, use, and management of cleaning agents and disinfectants used for cleaning and sanitizing equipment involved in the manufacturing of dental dosage forms, ensuring effective removal…

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Dental Dosage Forms

SOP for Laminar Air Flow

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SOP for Laminar Air Flow Standard Operating Procedure for Using Laminar Air Flow 1) Purpose The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the laminar air flow unit used in the manufacturing of otic dosage forms to ensure a sterile and contaminant-free environment. 2) Scope This…

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Otic (Ear) Dosage Forms

SOP for Trending Analysis of Equipment Performance

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SOP for Trending Analysis of Equipment Performance Standard Operating Procedure for Trending Analysis of Equipment Performance 1) Purpose The purpose of this SOP is to establish procedures for conducting trending analysis of equipment performance data used in the manufacturing of dental dosage forms, enabling proactive identification of trends, deviations, and opportunities for continuous improvement. 2)…

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Dental Dosage Forms

SOP for Sealing Line for Eye Drops

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SOP for Sealing Line for Eye Drops Standard Operating Procedure for Sealing 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 sealing line specifically designed for eye drops, ensuring efficient and compliant production practices….

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Ocular (Eye) Dosage Forms

SOP for Hot Air Oven

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SOP for Hot Air Oven Standard Operating Procedure for Using Hot Air Oven 1) Purpose The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the hot air oven used in the manufacturing of otic dosage forms to ensure effective drying and sterilization of materials and equipment. 2)…

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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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