Standard Operating Procedure for Stability Studies of Nasal Formulations
1) Purpose
This SOP outlines the procedures required for conducting stability studies of nasal formulations, which evaluate the physical, chemical, and microbiological stability of the product over time under various storage conditions.
2) Scope
This SOP applies to personnel involved in conducting stability studies on nasal formulations, including sprays, powders, and gels, to ensure that the products meet shelf-life and regulatory requirements.
3) Responsibilities
- Operators: Responsible for preparing and storing the samples for stability testing and ensuring the samples are handled correctly.
- Quality Assurance (QA): Ensures that the stability tests are conducted according to established guidelines and that the results meet regulatory standards.
- Maintenance Team: Ensures that the stability chambers are maintained and calibrated regularly.
4) Procedure
4.1 Sample Preparation
4.1.1 Selection of Test Samples
- Select representative samples of the nasal formulation for stability testing, including the active pharmaceutical ingredient (API), excipients, and final product. Document the selection of samples in the stability study protocol.
4.1.2 Weighing and Filling
- Weigh the samples using a calibrated balance and fill them into suitable containers for testing. Ensure that the samples are filled under the same conditions as the final product.
4.2 Storage Conditions
4.2.1 Storage in Stability Chambers
- Store the samples in stability chambers set to specific environmental conditions, such as temperature and humidity. Common conditions include 25°C/60% RH for long-term stability and 40°C/75% RH for accelerated stability testing.
- Document the storage conditions and ensure that the chambers are regularly calibrated and maintained.
4.3 Stability Testing
4.3.1 Physical Stability Testing
- Monitor the physical properties of the nasal formulations over time, such as appearance, color, and odor. Record any changes in the stability testing log.
4.3.2 Chemical Stability Testing
- Test the chemical stability of the active ingredient by measuring the API concentration at different time intervals (e.g., 1 month, 3 months, 6 months) using a validated method, such as HPLC.
- Record the results in the chemical stability log and compare them against the initial values to determine any degradation.
4.3.3 Microbiological Testing
- Conduct microbiological testing of the nasal formulations to ensure that they remain free of contamination during the stability period. Perform tests such as microbial count and endotoxin testing.
- Document the results in the microbiological testing log.
4.4 Documentation
- Record all stability testing results, including physical, chemical, and microbiological properties, in the stability study protocol and ensure QA reviews and signs off on the documentation.
- Ensure that the results are regularly reported to management and that any deviations from the expected stability profile are addressed.
4.5 Equipment Calibration and Cleaning
- Calibrate the stability chambers and testing equipment as per the calibration schedule, and document the results in the calibration log.
- Ensure that all equipment is cleaned and maintained according to the cleaning validation protocol.
5) Abbreviations, if any
- API: Active Pharmaceutical Ingredient
- QA: Quality Assurance
- HPLC: High-Performance Liquid Chromatography
6) Documents, if any
- Stability Study Protocol
- Chemical Stability Log
- Microbiological Testing Log
- Physical Stability Log
- Calibration Log
7) References, if any
- ICH Q1A – Stability Testing Guidelines
- FDA Guidance for Nasal Drug Products
8) SOP Version
Version 1.0
Annexure
1. Chemical Stability Testing Log Template
| Date | Formulation | API Concentration (%) | Test Method | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | Concentration | Method | Operator Name | QA Name |
2. Microbiological Testing Log Template
| Date | Formulation | Test | Results | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | Microbiological Test | Results | Operator Name | QA Name |
3. Physical Stability Testing Log Template
| Date | Formulation | Physical Appearance | Changes Observed | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | Appearance | Observations | Operator Name | QA Name |
4. Cleaning Log Template
| Date | Equipment ID | Cleaning Procedure | Operator Initials | QA Approval | |
|---|---|---|---|---|---|
| DD/MM/YYYY | Equipment Name/ID | Cleaning Method | Operator Name | QA Name | |
5. Calibration Log Template
| Date | Equipment ID | Calibration Procedure | Calibration Results | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Equipment Name/ID | Calibration Method | Pass/Fail | Operator Name | QA Name |