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 |