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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Tag: SOP for In Silico Modeling

SOP for Compliance with Global Animal Testing Regulations

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SOP for Compliance with Global Animal Testing Regulations Standard Operating Procedure (SOP) for Compliance with Global Animal Testing Regulations 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to ensure that all animal testing conducted during preclinical studies complies with global animal testing regulations. This SOP outlines the procedures for adhering to international…

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Drug Discovery

SOP for Preparing and Submitting Animal Study Reports

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SOP for Preparing and Submitting Animal Study Reports Standard Operating Procedure (SOP) for Preparing and Submitting Animal Study Reports 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for preparing and submitting animal study reports. Accurate and comprehensive reporting of animal study data is crucial to meet regulatory requirements,…

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Drug Discovery

SOP for Preclinical Study Data Review Meetings

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SOP for Preclinical Study Data Review Meetings Standard Operating Procedure (SOP) for Preclinical Study Data Review Meetings 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting data review meetings during preclinical studies. These meetings are critical to ensuring that study data is reviewed systematically, any issues are…

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Drug Discovery

SOP for Preparation of Samples for Omics-Based Studies

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SOP for Preparation of Samples for Omics-Based Studies Standard Operating Procedure (SOP) for Preparation of Samples for Omics-Based Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the preparation of samples for omics-based studies. Omics-based technologies such as genomics, proteomics, metabolomics, and transcriptomics are increasingly used in preclinical…

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Drug Discovery

SOP for Documentation and Record Keeping in Preclinical Studies

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SOP for Documentation and Record Keeping in Preclinical Studies Standard Operating Procedure (SOP) for Documentation and Record Keeping in Preclinical Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for documentation and record-keeping in preclinical studies. Proper documentation and record keeping are essential to ensure compliance with regulatory requirements,…

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Drug Discovery

SOP for Risk Management in Preclinical Studies

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SOP for Risk Management in Preclinical Studies Standard Operating Procedure (SOP) for Risk Management in Preclinical Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for identifying, assessing, and managing risks during preclinical studies. Risk management is crucial to mitigate potential issues that could impact the study’s success,…

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Drug Discovery

SOP for Statistical Analysis of Preclinical Data

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SOP for Statistical Analysis of Preclinical Data Standard Operating Procedure (SOP) for Statistical Analysis of Preclinical Data 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for conducting statistical analysis of data generated during preclinical studies. Statistical analysis is essential for interpreting study results, drawing valid conclusions, and ensuring…

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Drug Discovery

SOP for Monitoring Preclinical Study Progress

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SOP for Monitoring Preclinical Study Progress Standard Operating Procedure (SOP) for Monitoring Preclinical Study Progress 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for monitoring the progress of preclinical studies. Monitoring the progress of preclinical studies is critical to ensure that they are conducted according to the study…

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Drug Discovery

SOP for Collaboration with External Preclinical Testing Labs

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SOP for Collaboration with External Preclinical Testing Labs Standard Operating Procedure (SOP) for Collaboration with External Preclinical Testing Labs 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for collaborating with external preclinical testing laboratories. Collaborating with external labs is a common practice in drug development when specialized expertise,…

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Drug Discovery

SOP for Use of Alternative Models in Preclinical Studies

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SOP for Use of Alternative Models in Preclinical Studies Standard Operating Procedure (SOP) for Use of Alternative Models in Preclinical Studies 1) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for the use of alternative models in preclinical studies. Alternative models are crucial for reducing, refining, and replacing the…

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Drug Discovery

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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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