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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 Preparation of Granules

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SOP for Preparation of Granules Standard Operating Procedure for Granule Preparation 1) Purpose The purpose of this SOP is to provide a standardized procedure for the preparation of granules in the pharmaceutical manufacturing process to ensure consistency, quality, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the preparation…

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Powder & Granules

SOP for Endotoxin Testing in Aseptic Transdermal Patches

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SOP for Endotoxin Testing in Aseptic Transdermal Patches Standard Operating Procedure for Endotoxin Testing in Aseptic Transdermal Patches 1) Purpose To establish a standardized procedure for conducting endotoxin testing in aseptic transdermal patches to ensure they are free from bacterial endotoxins that could cause pyrogenic reactions. 2) Scope This SOP applies to the quality control…

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Transdermal Patches

SOP for Preventing Contamination in Lotions Production

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SOP for Preventing Contamination in Lotions Production Standard Operating Procedure for Preventing Contamination in Lotions Production 1) Purpose The purpose of this SOP is to establish procedures for preventing contamination during lotions production to ensure product quality, safety, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in lotions production…

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Lotions

SOP for Cream Emulsifier

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SOP for Cream Emulsifier Operation and Maintenance of Cream Emulsifier 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the cream emulsifier to ensure efficient emulsification of cream formulations. 2) Scope This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the cream emulsifier…

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Vaginal Dosage Forms

SOP for Sterility Testing in Aseptic Transdermal Patches

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SOP for Sterility Testing in Aseptic Transdermal Patches Standard Operating Procedure for Sterility Testing in Aseptic Transdermal Patches 1) Purpose To establish a standardized procedure for conducting sterility testing in aseptic transdermal patches to ensure they are free from viable contaminating microorganisms. 2) Scope This SOP applies to the quality control (QC) and quality assurance…

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Transdermal Patches

SOP for Stability Testing of IM and SC Products

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SOP for Stability Testing of IM and SC Products Standard Operating Procedure for Stability Testing of IM and SC Products 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting stability testing of Intramuscular (IM) and Subcutaneous (SC) products to assess their quality, safety, and efficacy over time….

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Injectables

SOP for Raw Material Inspection for Lotions

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SOP for Raw Material Inspection for Lotions Standard Operating Procedure for Raw Material Inspection for Lotions 1) Purpose The purpose of this SOP is to establish procedures for the inspection and acceptance of raw materials used in the production of lotions to ensure they meet quality standards and specifications. 2) Scope This SOP applies to…

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Lotions

SOP for Preparation of Metered-Dose Inhalers (MDIs)

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SOP for Preparation of Metered-Dose Inhalers (MDIs) Procedure for Preparing MDIs 1) Purpose The purpose of this SOP is to outline the procedure for the preparation of metered-dose inhalers (MDIs) in the pharmaceutical industry, ensuring consistent quality and compliance with regulatory standards. 2) Scope This SOP applies to all personnel involved in the preparation of…

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Metered-Dose Inhaler

SOP for Foreign Particulate Matter Testing in Transdermal Patches

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SOP for Foreign Particulate Matter Testing in Transdermal Patches Standard Operating Procedure for Foreign Particulate Matter Testing in Transdermal Patches 1) Purpose To establish a standardized procedure for detecting and quantifying foreign particulate matter in transdermal patches to ensure product safety and quality. 2) Scope This SOP applies to the quality control (QC) and quality…

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Transdermal Patches

SOP for Preparation of Powders

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SOP for Preparation of Powders Standard Operating Procedure for Powder Preparation 1) Purpose The purpose of this SOP is to provide a standardized procedure for the preparation of powders in the pharmaceutical manufacturing process to ensure consistency, quality, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel involved in the preparation…

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Powder & Granules

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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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