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SOP for Solvent Handling and Selection in Nasal Spray Formulation

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SOP for Solvent Handling and Selection in Nasal Spray Formulation



Standard Operating Procedure for Solvent Handling and Selection in Nasal Spray Formulation

1) Purpose

The purpose of this SOP is to provide guidelines for the selection and handling of solvents used in nasal spray formulations to ensure quality, safety, and regulatory compliance.

2) Scope

This SOP applies to all personnel involved in the selection, handling, and storage of solvents used in nasal spray formulations at [Company Name].

3) Responsibilities

  • Operators: Responsible for safe handling of solvents.
  • QA: Ensures that the selected solvents meet quality and safety standards.
  • Maintenance Team: Responsible for the maintenance of solvent storage systems.
See also  Nasal Spray Formulations : SOP for Lyophilization of Nasal Powders

4) Procedure

4.1 Selection of Solvents

  • Choose solvents based on compatibility with APIs, excipients, and formulation needs.
  • Ensure solvents are pharmaceutically approved and meet regulatory guidelines.

4.2 Handling and Storage of Solvents

4.2.1 Solvent Safety Guidelines

  • Wear appropriate personal protective equipment (PPE) when handling solvents.
  • Ensure solvents are stored in designated, well-ventilated areas with appropriate temperature control.

4.2.2 Solvent Dispensing

  • Use appropriate containers for solvent transfer, ensuring no cross-contamination.
  • Document each solvent transfer in the solvent usage log, specifying batch numbers and operator initials.

4.3 Solvent Compatibility Testing

4.3.1 Testing for Formulation Compatibility

  • Conduct compatibility tests
between the solvent and active ingredients to ensure stability and efficacy.
  • QA must review and sign off on compatibility testing results.
  • 4.4 Documentation

    • Maintain records of solvent usage, storage, and testing in the solvent logbook.
    • Ensure all documentation is verified by QA personnel to ensure traceability and compliance with regulatory standards.
    • Solvent compatibility results should be retained and archived for future reference and audits.

    5) Abbreviations, if any

    • PPE: Personal Protective Equipment
    • QA: Quality Assurance

    6) Documents, if any

    • Solvent Usage Log
    • Compatibility Testing Results

    7) References, if any

    • ICH Q3C(R6) – Impurities: Guidelines for Residual Solvents

    8) SOP Version

    Version 1.0

    Annexure

    Solvent Usage Log Template

    Date Solvent Name Batch Number Quantity Dispensed Operator Initials Remarks
    DD/MM/YYYY Solvent Name Batch No. Quantity Operator Name Process followed as per SOP
               
    See also  SOP for Use of Permeation Enhancers in Nasal Formulations
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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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