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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOPs for Analytical Method Development

SOP for Analytical Method Development Robustness Testing

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The purpose of this SOP is to outline the procedure for conducting robustness testing during the analytical method development process, ensuring the reliability and robust performance of analytical methods under varying conditions.
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Analytical Method Development

SOP for Analytical Method Development System Suitability Testing

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The purpose of this SOP is to outline the procedure for conducting system suitability testing (SST) during the analytical method development process, ensuring the reliability and reproducibility of analytical systems and methods.
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Analytical Method Development

SOP for Analytical Method Development Stability Testing of Analytical Standards

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The purpose of this SOP is to outline the procedure for conducting stability testing of analytical standards during the analytical method development process, ensuring the reliability and accuracy of standards used for method validation and routine testing.
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Analytical Method Development

SOP for Analytical Method Development Microbiological Method Development

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The purpose of this SOP is to outline the procedure for developing microbiological methods during the analytical method development process, ensuring accurate detection and enumeration of microorganisms in pharmaceutical formulations.
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Analytical Method Development

SOP for Analytical Method Development Physical Testing Method Development

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The purpose of this SOP is to outline the procedure for developing physical testing methods during the analytical method development process, ensuring accurate characterization of physical properties of pharmaceutical formulations.
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Analytical Method Development

SOP for Analytical Method Development Titration Method Development

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The purpose of this SOP is to outline the procedure for developing titration methods during the analytical method development process, ensuring accurate determination of analyte concentration using titrimetric techniques.
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Analytical Method Development

SOP for Analytical Method Development Spectroscopic Method Development

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The purpose of this SOP is to outline the procedure for developing spectroscopic methods during the analytical method development process, ensuring accurate measurement of analytes using spectroscopic techniques.
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Analytical Method Development

SOP for Analytical Method Development Chromatographic Method Development

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The purpose of this SOP is to outline the procedure for developing chromatographic methods during the analytical method development process, ensuring accurate separation and quantification of analytes in pharmaceutical formulations.
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Analytical Method Development

SOP for Analytical Method Development Particle Size Method Development

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The purpose of this SOP is to outline the procedure for developing particle size methods during the analytical method development process, ensuring accurate measurement of particle size distribution in pharmaceutical formulations.
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Analytical Method Development

SOP for Analytical Method Development Dissolution Method Development

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The purpose of this SOP is to outline the procedure for developing dissolution methods during the analytical method development process, ensuring accurate assessment of drug release from dosage forms.
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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
  • 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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