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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 Tablet Coating Machine

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SOP for Tablet Coating Machine Operation and Maintenance of Tablet Coating Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the tablet coating machine to ensure the production of coated tablets with uniform quality and appearance. 2) Scope This SOP applies to all personnel involved in the…

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Vaginal Dosage Forms

SOP for Particle Size Analysis in Lotions

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SOP for Particle Size Analysis in Lotions Standard Operating Procedure for Particle Size Analysis of Lotions 1) Purpose The purpose of this SOP is to outline the procedure for conducting particle size analysis of lotions to ensure uniformity and consistency in product quality. 2) Scope This SOP applies to all personnel involved in the particle…

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Lotions

SOP for Packaging Component Testing for Transdermal Patches

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SOP for Packaging Component Testing for Transdermal Patches Standard Operating Procedure for Packaging Component Testing for Transdermal Patches 1) Purpose To establish procedures for testing and qualifying packaging components used for packaging transdermal patches, ensuring their compatibility and suitability for maintaining product integrity and stability. 2) Scope This SOP applies to the quality control (QC)…

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Transdermal Patches

SOP for Aseptic Media Fill Trials for IM and SC Injections

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SOP for Aseptic Media Fill Trials for IM and SC Injections Standard Operating Procedure for Aseptic Media Fill Trials for IM and SC Injections 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting aseptic media fill trials to validate the aseptic filling process for Intramuscular (IM) and…

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Injectables

SOP for pH Testing of Lotions

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SOP for pH Testing of Lotions Standard Operating Procedure for Lotion pH Testing 1) Purpose The purpose of this SOP is to outline the procedure for conducting pH testing of lotions to ensure the product maintains the desired pH range for safety and efficacy. 2) Scope This SOP applies to all personnel involved in the…

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Lotions

SOP for Stability-Indicating Methods Development for Transdermal Patches

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SOP for Stability-Indicating Methods Development for Transdermal Patches Standard Operating Procedure for Stability-Indicating Methods Development for Transdermal Patches 1) Purpose To establish procedures for developing and validating stability-indicating analytical methods for assessing the stability of active pharmaceutical ingredients (APIs) and formulations in transdermal patches. 2) Scope This SOP applies to the analytical development and quality…

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Transdermal Patches

SOP for Suppository Filling and Sealing Machine

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SOP for Suppository Filling and Sealing Machine Operation and Maintenance of Suppository Filling and Sealing Machine 1) Purpose The purpose of this SOP is to outline the procedures for operating and maintaining the suppository filling and sealing machine to ensure the production of high-quality suppositories. 2) Scope This SOP applies to all personnel involved in…

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Vaginal Dosage Forms

Transdermal Patches: SOP for Stability-Indicating Methods Development for Transdermal Patches

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SOP for Stability-Indicating Methods Development for Transdermal Patches Standard Operating Procedure for Stability-Indicating Methods Development for Transdermal Patches 1) Purpose To establish procedures for developing and validating stability-indicating analytical methods for assessing the stability of active pharmaceutical ingredients (APIs) and formulations in transdermal patches. 2) Scope This SOP applies to the analytical development and quality…

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Transdermal Patches

SOP for Pharmacovigilance Metrics and Key Performance Indicators (KPIs)

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SOP for Pharmacovigilance Metrics and Key Performance Indicators (KPIs) Guidelines for Pharmacovigilance Metrics and KPIs 1) Purpose The purpose of this SOP is to outline the procedures for defining, collecting, analyzing, and reporting pharmacovigilance metrics and key performance indicators (KPIs) to ensure the effectiveness and efficiency of pharmacovigilance activities. 2) Scope This SOP applies to…

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Pharmacovigilance

SOP for Viscosity Testing of Lotions

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SOP for Viscosity Testing of Lotions Standard Operating Procedure for Lotion Viscosity Testing 1) Purpose The purpose of this SOP is to outline the procedure for conducting viscosity testing of lotions to ensure consistent product quality and performance. 2) Scope This SOP applies to all personnel involved in the viscosity testing of lotions within the…

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Lotions

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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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