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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 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

SOP for Compressed Air System Maintenance

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SOP for Compressed Air System Maintenance Standard Operating Procedure for Compressed Air System Maintenance 1) Purpose The purpose of this SOP is to establish procedures for the maintenance of compressed air systems used in the manufacturing of dental dosage forms to ensure air quality and compliance with regulatory standards. 2) Scope This SOP applies to…

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Dental Dosage Forms

SOP for Hygroscopicity Testing in Granules

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SOP for Hygroscopicity Testing in Granules Standard Operating Procedure for Hygroscopicity Testing in Granules 1) Purpose The purpose of this SOP is to outline the procedure for conducting hygroscopicity testing of granules in the pharmaceutical industry to evaluate the moisture absorption properties under controlled conditions. 2) Scope This SOP applies to all personnel involved in…

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Powder & Granules

SOP for Filling and Sealing of Vaginal Dosage Forms

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SOP for Filling and Sealing of Vaginal Dosage Forms Filling and Sealing Procedures for Vaginal Dosage Forms 1) Purpose The purpose of this SOP is to outline the procedure for filling and sealing vaginal dosage forms to ensure consistency, quality, and sterility of the final product. 2) Scope This SOP applies to all personnel involved…

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Vaginal Dosage Forms

SOP for Visual Inspection of Filled Ampoules

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SOP for Visual Inspection of Filled Ampoules Standard Operating Procedure for Visual Inspection of Filled Ampoules 1) Purpose The purpose of this SOP is to establish a standardized procedure for the visual inspection of filled ampoules to ensure their quality, integrity, and compliance with regulatory requirements for ocular dosage forms. 2) Scope This SOP applies…

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Ocular (Eye) Dosage Forms

SOP for Water System Maintenance

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SOP for Water System Maintenance Standard Operating Procedure for Water System Maintenance 1) Purpose The purpose of this SOP is to establish procedures for the maintenance of water systems used in the manufacturing of dental dosage forms to ensure water quality and compliance with regulatory standards. 2) Scope This SOP applies to all water systems…

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Dental Dosage Forms

Vaginal Dosage Forms: SOP for Finished Product Sampling

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SOP for Finished Product Sampling Sampling of Finished Vaginal Dosage Forms 1) Purpose The purpose of this SOP is to establish the procedure for sampling finished vaginal dosage forms to ensure that samples are representative of the entire batch for quality testing. 2) Scope This SOP applies to all personnel involved in the sampling of…

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Vaginal Dosage Forms

SOP for Handling of Deviations

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SOP for Handling of Deviations Standard Operating Procedure for Handling of Deviations 1) Purpose The purpose of this SOP is to establish procedures for handling and investigating deviations from established processes, procedures, and specifications to ensure product quality and compliance. 2) Scope This SOP applies to all deviations identified within the manufacturing facility that may…

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Rectal 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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