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.

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