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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 Measurement of Spray Force in Aerosols

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SOP for Measurement of Spray Force in Aerosols Standard Operating Procedure for Measurement of Spray Force in Aerosols 1) Purpose The purpose of this SOP is to establish procedures for the measurement of spray force in aerosol products to ensure product performance, consistency, and compliance with regulatory requirements. 2) Scope This SOP applies to the…

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Aerosols

SOP for Technology Transfer in Transdermal Patches Production

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SOP for Technology Transfer in Transdermal Patches Production Standard Operating Procedure for Technology Transfer in Transdermal Patches Production 1) Purpose To establish a standardized procedure for the transfer of technology related to transdermal patches production from the development stage to commercial manufacturing, ensuring consistency, quality, and compliance. 2) Scope This SOP applies to all personnel…

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Transdermal Patches

Transdermal Patches: SOP for Product Development for New Transdermal Patch Formulations

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SOP for Product Development for New Transdermal Patch Formulations Standard Operating Procedure for Product Development for New Transdermal Patch Formulations 1) Purpose To establish a systematic approach for developing new formulations of transdermal patches, ensuring efficacy, safety, and compliance with regulatory requirements. 2) Scope This SOP applies to the product development team, including formulation scientists,…

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Transdermal Patches

SOP for Continuous Improvement in Transdermal Patches Production

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SOP for Continuous Improvement in Transdermal Patches Production Standard Operating Procedure for Continuous Improvement in Transdermal Patches Production 1) Purpose To establish a framework for identifying, implementing, and evaluating continuous improvement initiatives in the production of transdermal patches to enhance efficiency, quality, and compliance. 2) Scope This SOP applies to all personnel involved in the…

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Transdermal Patches

SOP for Visual and Physical Inspection of Syringes and Vials

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SOP for Visual and Physical Inspection of Syringes and Vials Standard Operating Procedure for Visual and Physical Inspection of Syringes and Vials 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting visual and physical inspections of syringes and vials to ensure product quality and compliance with specifications….

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Injectables

SOP for Evaluation of Propellant Leakage in Aerosols

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SOP for Evaluation of Propellant Leakage in Aerosols Standard Operating Procedure for Evaluation of Propellant Leakage in Aerosols 1) Purpose The purpose of this SOP is to establish procedures for the evaluation of propellant leakage in aerosol products to ensure product integrity, safety, and compliance with regulatory requirements. 2) Scope This SOP applies to the…

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Aerosols

SOP for Change Management in Transdermal Patches Production

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SOP for Change Management in Transdermal Patches Production Standard Operating Procedure for Change Management in Transdermal Patches Production 1) Purpose To establish a systematic procedure for managing changes to processes, equipment, materials, and documentation in the production of transdermal patches to ensure controlled implementation, evaluation of impact, and compliance with regulatory requirements. 2) Scope This…

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Transdermal Patches

SOP for Pharmacovigilance Risk Assessment Team (RAT)

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SOP for Pharmacovigilance Risk Assessment Team (RAT) Guidelines for Pharmacovigilance Risk Assessment Team (RAT) 1) Purpose The purpose of this SOP is to outline the procedures for the formation and functioning of the Risk Assessment Team (RAT) within the pharmacovigilance department, ensuring systematic evaluation and management of risks associated with pharmaceutical products. 2) Scope This…

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Pharmacovigilance

SOP for Risk Management in Transdermal Patches Production

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SOP for Risk Management in Transdermal Patches Production Standard Operating Procedure for Risk Management in Transdermal Patches Production 1) Purpose To establish a systematic approach for identifying, assessing, mitigating, and monitoring risks associated with the production of transdermal patches to ensure product quality, patient safety, and regulatory compliance. 2) Scope This SOP applies to all…

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Transdermal Patches

SOP for Root Cause Analysis in Transdermal Patches Production

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SOP for Root Cause Analysis in Transdermal Patches Production Standard Operating Procedure for Root Cause Analysis in Transdermal Patches Production 1) Purpose To establish a procedure for conducting root cause analysis (RCA) in the production of transdermal patches to identify and address the underlying causes of quality issues. 2) Scope This SOP applies to all…

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Transdermal Patches

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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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