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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 Packaging Material Selection for Granules

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SOP for Packaging Material Selection for Granules Standard Operating Procedure for Packaging Material Selection for Granules 1) Purpose The purpose of this SOP is to outline the procedure for selecting appropriate packaging materials for granules in the pharmaceutical industry to ensure compatibility, stability, and integrity of the packaged product. 2) Scope This SOP applies to…

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Powder & Granules

Ocular (Eye) Dosage Forms: SOP for Gel Preparation System

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SOP for Gel Preparation System Standard Operating Procedure for Gel Preparation System 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 gel preparation system to ensure the consistent and safe production of ocular gels in compliance with regulatory…

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Ocular (Eye) Dosage Forms

SOP for Packaging Material Storage

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SOP for Packaging Material Storage Storage Guidelines for Packaging Materials 1) Purpose The purpose of this SOP is to outline the procedure for proper storage of packaging materials to ensure their quality and integrity are maintained until they are used in the manufacturing of vaginal dosage forms. 2) Scope This SOP applies to all personnel…

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Vaginal Dosage Forms

SOP for In-Process Control During Manufacturing

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SOP for In-Process Control During Manufacturing Standard Operating Procedure for In-Process Control During Manufacturing 1) Purpose The purpose of this SOP is to establish procedures for conducting in-process controls during the manufacturing of dental dosage forms to ensure product quality and compliance with regulatory standards. 2) Scope This SOP applies to all stages of manufacturing…

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Dental Dosage Forms

SOP for Metal Detector Operation

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SOP for Metal Detector Operation Standard Operating Procedure for Metal Detector Usage in Ocular Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish a standardized procedure for the operation of metal detectors to ensure the detection and removal of metallic contaminants in ocular dosage forms, thereby ensuring product safety and compliance…

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Ocular (Eye) Dosage Forms

SOP for Packaging Material Selection for Powders

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SOP for Packaging Material Selection for Powders Standard Operating Procedure for Packaging Material Selection for Powders 1) Purpose The purpose of this SOP is to outline the procedure for selecting appropriate packaging materials for powders in the pharmaceutical industry to ensure compatibility, stability, and integrity of the packaged product. 2) Scope This SOP applies to…

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Powder & Granules

SOP for Validation of Processes

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SOP for Validation of Processes Standard Operating Procedure for Validation of Processes 1) Purpose The purpose of this SOP is to establish procedures for the validation of processes, including equipment, systems, and methods, to ensure consistency, reliability, and compliance with regulatory requirements. 2) Scope This SOP applies to all processes within the manufacturing facility that…

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Rectal Dosage Forms

SOP for Cleanroom Maintenance

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SOP for Cleanroom Maintenance Standard Operating Procedure for Cleanroom Maintenance 1) Purpose The purpose of this SOP is to establish procedures for the maintenance of cleanrooms used in the manufacturing of dental dosage forms to ensure cleanliness and compliance with regulatory standards. 2) Scope This SOP applies to all cleanrooms where dental pastes, gels, and…

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Dental Dosage Forms

SOP for Packaging Material Receipt and Inspection

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SOP for Packaging Material Receipt and Inspection Receipt and Inspection Procedures for Packaging Materials 1) Purpose The purpose of this SOP is to define the procedure for receiving and inspecting packaging materials to ensure they meet the required quality standards and specifications for use in manufacturing vaginal dosage forms. 2) Scope This SOP applies to…

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Vaginal Dosage Forms

SOP for Leak Testing of Filled Containers

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SOP for Leak Testing of Filled Containers Standard Operating Procedure for Leak Testing of Filled Containers 1) Purpose The purpose of this SOP is to establish a standardized procedure for leak testing of filled containers to ensure their integrity, prevent contamination, and ensure compliance with regulatory requirements for ocular dosage forms. 2) Scope This SOP…

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Ocular (Eye) 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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