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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Tag: Clinical trial SOPs Data management SOPs Electronic systems validation

SOP for Site Selection and Initiation

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Standard Operating Procedure for Selecting and Initiating Clinical Research Sites Purpose The purpose of this SOP is to establish the process for selecting and initiating clinical research sites in order to ensure the success of clinical trials and clinical studies. This SOP ensures that sites are capable of conducting studies according to the study protocol,…

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Clinical Studies

Clinical Studies: SOP for Informed Consent Process

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Standard Operating Procedure for Obtaining Informed Consent in Clinical Research Purpose The purpose of this SOP is to establish the process for obtaining informed consent from participants in clinical trials and clinical studies. This SOP ensures that participants are provided with all necessary information to make an informed decision about their participation. Scope This SOP…

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Clinical Studies

SOP for Study Protocol Development and Approval

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Standard Operating Procedure for Planning and Approving Clinical Study Protocols Purpose The purpose of this SOP is to outline the process for developing and obtaining approval for study protocols in clinical research. This SOP aims to ensure that protocols are scientifically sound, ethically compliant, and adhere to regulatory standards. Scope This SOP applies to all…

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Clinical Studies

SOP for Clinical Trials/Clinical Studies

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Standard Operating Procedure for Conducting Clinical Research Purpose The purpose of this SOP is to establish the standard procedures for conducting clinical trials and clinical studies to ensure compliance with regulatory requirements, ethical standards, and safety measures for participants. Scope This SOP applies to all personnel involved in the planning, conduct, monitoring, and reporting of…

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Clinical Studies

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
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers 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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