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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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Tag: Product Recall Management SOP

SOP for Retained Sample Management

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SOP for Retained Sample Management Standard Operating Procedure for Retained Sample Management 1) Purpose This SOP outlines the procedures for the handling, storage, retention, and disposal of retained samples to ensure traceability, integrity, and compliance with regulatory requirements in pharmaceutical manufacturing. 2) Scope This SOP applies to all personnel involved in the collection, labeling, storage,…

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Quality Assurance

SOP for Reference Standard Management

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SOP for Reference Standard Management Standard Operating Procedure for Reference Standard Management 1) Purpose This SOP outlines the procedures for the handling, storage, qualification, use, and disposal of reference standards to ensure their integrity, traceability, and compliance with regulatory requirements in pharmaceutical testing and analysis. 2) Scope This SOP applies to all laboratory personnel involved…

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Quality Assurance

SOP for Laboratory Notebook Management

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SOP for Laboratory Notebook Management Standard Operating Procedure for Laboratory Notebook Management 1) Purpose This SOP outlines the procedures for maintaining laboratory notebooks to ensure accurate, complete, and traceable documentation of experimental procedures, observations, and results in pharmaceutical research and development. 2) Scope This SOP applies to all laboratory personnel responsible for maintaining laboratory notebooks…

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Quality Assurance

SOP for Laboratory Sample Management

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SOP for Laboratory Sample Management Standard Operating Procedure for Laboratory Sample Management 1) Purpose This SOP outlines the procedures for the handling, storage, tracking, and disposal of laboratory samples to ensure sample integrity, traceability, and compliance with regulatory requirements in pharmaceutical testing and analysis. 2) Scope This SOP applies to all laboratory personnel involved in…

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Quality Assurance

SOP for Laboratory Reagent and Solution Preparation

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SOP for Laboratory Reagent and Solution Preparation Standard Operating Procedure for Laboratory Reagent and Solution Preparation 1) Purpose This SOP outlines the procedures for the preparation, labeling, and documentation of laboratory reagents and solutions to ensure accuracy, reliability, and traceability in pharmaceutical testing and analysis. 2) Scope This SOP applies to all laboratory personnel involved…

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Quality Assurance

SOP for Laboratory Instrument Maintenance

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SOP for Laboratory Instrument Maintenance Standard Operating Procedure for Laboratory Instrument Maintenance 1) Purpose This SOP outlines the procedures for the routine maintenance of laboratory instruments to ensure their optimal performance, reliability, and longevity in pharmaceutical testing and analysis. 2) Scope This SOP applies to all laboratory instruments used for testing, analysis, and measurement within…

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Quality Assurance

SOP for Laboratory Instrument Calibration

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SOP for Laboratory Instrument Calibration Standard Operating Procedure for Laboratory Instrument Calibration 1) Purpose This SOP outlines the procedures for the calibration of laboratory instruments to ensure accuracy, reliability, and traceability of measurements in pharmaceutical testing and analysis. 2) Scope This SOP applies to all laboratory instruments used for testing, analysis, and measurement within the…

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Quality Assurance

SOP for Data Integrity Assurance

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SOP for Data Integrity Assurance Standard Operating Procedure for Data Integrity Assurance 1) Purpose This SOP outlines the procedures to ensure data integrity in pharmaceutical manufacturing and documentation practices to comply with regulatory requirements and maintain accuracy, completeness, and reliability of data. 2) Scope This SOP applies to all personnel involved in generating, recording, reviewing,…

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Quality Assurance

SOP for Electronic Records and Signatures

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SOP for Electronic Records and Signatures Standard Operating Procedure for Electronic Records and Signatures 1) Purpose This SOP outlines the procedures for managing electronic records and signatures in pharmaceutical manufacturing to ensure compliance with regulatory requirements for data integrity, authenticity, and traceability. 2) Scope This SOP applies to all electronic records and signatures generated, reviewed,…

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Quality Assurance

Quality Assurance: SOP for Data Integrity Assurance

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SOP for Data Integrity Assurance Standard Operating Procedure for Data Integrity Assurance 1) Purpose This SOP outlines the procedures to ensure data integrity in pharmaceutical manufacturing and documentation practices to comply with regulatory requirements and maintain accuracy, completeness, and reliability of data. 2) Scope This SOP applies to all personnel involved in generating, recording, reviewing,…

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Quality Assurance

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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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