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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 Maintenance of Forklifts and Pallet Jacks

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SOP for Maintenance of Forklifts and Pallet Jacks Standard Operating Procedure for Maintenance of Forklifts and Pallet Jacks 1) Purpose The purpose of this SOP is to establish guidelines for the regular maintenance and inspection of forklifts and pallet jacks to ensure safe and reliable operation in pharmaceutical manufacturing facilities. 2) Scope This SOP applies…

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Maintenance Dept.

SOP for Formulation Development Strategy Selection

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SOP for Formulation Development Strategy Selection Selecting a Formulation Development Strategy 1) Purpose The purpose of this SOP is to outline the procedure for selecting an appropriate formulation development strategy, ensuring that the chosen strategy aligns with project objectives, regulatory requirements, and resource availability. 2) Scope This SOP applies to all formulation development projects within…

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Formulation Development

SOP for Preventing Contamination in Aerosol Production

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SOP for Preventing Contamination in Aerosol Production Standard Operating Procedure for Preventing Contamination in Aerosol Production 1) Purpose The purpose of this SOP is to outline procedures for preventing contamination during aerosol production processes in the pharmaceutical industry. Contamination prevention is critical to ensure product quality, safety, and compliance with regulatory requirements. 2) Scope This…

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Aerosols

SOP for Analytical Method Development Team Formation

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SOP for Analytical Method Development Team Formation Forming a Team for Analytical Method Development 1) Purpose The purpose of this SOP is to outline the procedure for forming a team dedicated to the development of analytical methods, ensuring the team comprises individuals with the necessary skills and expertise. 2) Scope This SOP applies to the…

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Analytical Method Development

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

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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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