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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 Formulation Development Plan Creation

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SOP for Formulation Development Plan Creation Creating a Formulation Development Plan 1) Purpose The purpose of this SOP is to provide a standardized procedure for creating a comprehensive formulation development plan, outlining all necessary steps, resources, and timelines required to successfully develop a pharmaceutical formulation. 2) Scope This SOP applies to all formulation development projects,…

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Formulation Development

Maintenance Dept.: SOP for Continuous Improvement in Maintenance Activities

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SOP for Continuous Improvement in Maintenance Activities Standard Operating Procedure for Continuous Improvement in Maintenance Activities 1) Purpose The purpose of this SOP is to establish guidelines for implementing continuous improvement initiatives in maintenance activities within pharmaceutical manufacturing facilities to enhance efficiency, reduce downtime, and optimize resource utilization. 2) Scope This SOP applies to all…

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Maintenance Dept.

SOP for Maintaining Sterility in Aerosol Production

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SOP for Maintaining Sterility in Aerosol Production Standard Operating Procedure for Maintaining Sterility in Aerosol Production 1) Purpose The purpose of this SOP is to establish procedures for maintaining sterility during aerosol production processes in the pharmaceutical industry. This ensures that aerosol products are free from microbial contamination, meeting regulatory requirements and quality standards. 2)…

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Aerosols

SOP for Pharmacovigilance Compliance Policy

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SOP for Pharmacovigilance Compliance Policy Guidelines for Pharmacovigilance Compliance 1) Purpose The purpose of this SOP is to outline the policies and procedures for ensuring compliance with pharmacovigilance regulations and guidelines to ensure patient safety and regulatory adherence. 2) Scope This SOP applies to all employees involved in pharmacovigilance activities, including the collection, evaluation, and…

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Pharmacovigilance

SOP for Formulation Development Team Formation

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SOP for Formulation Development Team Formation Establishing a Formulation Development Team 1) Purpose The purpose of this SOP is to provide a detailed procedure for forming a formulation development team, ensuring that the team is composed of appropriately qualified and skilled members to achieve project objectives. 2) Scope This SOP applies to all formulation development…

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Formulation Development

SOP for Analytical Method Development Project Initiation

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SOP for Analytical Method Development Project Initiation Initiating an Analytical Method Development Project 1) Purpose The purpose of this SOP is to define the procedure for initiating an analytical method development project, ensuring all necessary steps are taken to begin the project efficiently and effectively. 2) Scope This SOP applies to all personnel involved in…

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Analytical Method Development

SOP for Setting Parameters for Different IV Solutions

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SOP for Setting Parameters for Different IV Solutions Standard Operating Procedure for Setting Parameters for Different Intravenous (IV) Solutions 1) Purpose The purpose of this SOP is to define the procedures for setting and adjusting parameters on manufacturing equipment for different intravenous (IV) solutions to ensure product quality and consistency. 2) Scope This SOP applies…

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Injectables

SOP for Formulation Development Project Initiation

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SOP for Formulation Development Project Initiation Initiating a Formulation Development Project 1) Purpose The purpose of this SOP is to outline the steps required to initiate a formulation development project, ensuring all necessary preparations and approvals are in place for successful project commencement. 2) Scope This SOP applies to all formulation development projects undertaken by…

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Formulation Development

SOP for Raw Material Inspection for Aerosols

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SOP for Raw Material Inspection for Aerosols Standard Operating Procedure for Raw Material Inspection for Aerosols 1) Purpose The purpose of this SOP is to establish procedures for the inspection and acceptance of raw materials used in the production of aerosols in the pharmaceutical industry. This ensures that only quality raw materials meeting specified requirements…

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Aerosols

Maintenance Dept.: SOP for Health and Safety in Maintenance

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SOP for Health and Safety in Maintenance Standard Operating Procedure for Health and Safety in Maintenance 1) Purpose The purpose of this SOP is to establish guidelines for maintaining health and safety standards during maintenance activities in pharmaceutical manufacturing facilities to prevent injuries, ensure compliance with regulations, and promote a safe working environment. 2) Scope…

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Maintenance Dept.

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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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