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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 Blend Uniformity Testing in Powders

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SOP for Blend Uniformity Testing in Powders Standard Operating Procedure for Blend Uniformity Testing in Powders 1) Purpose The purpose of this SOP is to outline the procedure for testing blend uniformity of powder formulations in the pharmaceutical industry to ensure consistent distribution of active ingredients. 2) Scope This SOP applies to all personnel involved…

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Powder & Granules

SOP for Water System Validation

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SOP for Water System Validation Guidelines for Water System Validation in Vaginal Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish procedures for the validation of water systems used in the manufacturing of vaginal dosage forms to ensure the consistent production of high-quality water. 2) Scope This SOP applies to all…

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Vaginal Dosage Forms

SOP for Cleaning and Sanitation

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SOP for Cleaning and Sanitation Standard Operating Procedure for Cleaning and Sanitation 1) Purpose The purpose of this SOP is to establish procedures for the cleaning and sanitation of the manufacturing facility and equipment to ensure a hygienic environment and prevent contamination of pharmaceutical products. 2) Scope This SOP applies to all areas within the…

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Rectal Dosage Forms

SOP for Paste Manufacturing Equipment

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SOP for Paste Manufacturing Equipment Standard Operating Procedure for Paste Manufacturing Equipment 1) Purpose The purpose of this SOP is to provide guidelines for the operation and maintenance of equipment used in the manufacturing of dental pastes to ensure consistent product quality and compliance with regulatory standards. 2) Scope This SOP applies to all equipment…

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Dental Dosage Forms

Injectables: SOP for Change Control Management

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SOP for Change Control Management Standard Operating Procedure for Change Control Management 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish procedures for initiating, documenting, reviewing, approving, and implementing changes within the pharmaceutical manufacturing facility to ensure compliance with regulatory requirements, maintain product quality, and manage risks effectively. 2) Scope This…

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Injectables

SOP for Semi-Solid Dosage Form Production

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SOP for Semi-Solid Dosage Form Production Standard Operating Procedure for Producing Semi-Solid Dosage Forms 1) Purpose The purpose of this SOP is to provide guidelines for the production of semi-solid dosage forms, such as ointments, gels, and creams, to ensure consistent quality and compliance with regulatory standards. 2) Scope This SOP applies to the entire…

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Ocular (Eye) Dosage Forms

SOP for HVAC System Validation

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SOP for HVAC System Validation Guidelines for HVAC System Validation in Vaginal Dosage Form Manufacturing 1) Purpose The purpose of this SOP is to establish procedures for the validation of HVAC (Heating, Ventilation, and Air Conditioning) systems used in the manufacturing of vaginal dosage forms to ensure controlled environmental conditions. 2) Scope This SOP applies…

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Vaginal Dosage Forms

SOP for Friability Testing in Granules

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SOP for Friability Testing in Granules Standard Operating Procedure for Friability Testing in Granules 1) Purpose The purpose of this SOP is to outline the procedure for conducting friability testing on granule formulations in the pharmaceutical industry to assess their resistance to abrasion and mechanical stress. 2) Scope This SOP applies to all personnel involved…

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Powder & Granules

SOP for Water System Maintenance in MDI Production

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SOP for Water System Maintenance in MDI Production Water System Maintenance Procedures in MDI Production 1) Purpose The purpose of this SOP is to establish procedures for the maintenance and operation of the water system in metered-dose inhaler (MDI) production to ensure quality, purity, and compliance with regulatory requirements. 2) Scope This SOP applies to…

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Metered-Dose Inhaler

SOP for Emulsification Equipment

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SOP for Emulsification Equipment Standard Operating Procedure for Emulsification Equipment 1) Purpose The purpose of this SOP is to ensure the proper operation and maintenance of emulsification equipment used in the manufacturing of dental dosage forms to achieve consistent emulsion stability and product quality. 2) Scope This SOP applies to all emulsification equipment used in…

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Dental 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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