SOP for Stability Studies of Nasal Formulations

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

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

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

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

Date	Equipment ID	Cleaning Procedure	Operator Initials	QA Approval
DD/MM/YYYY	Equipment Name/ID	Cleaning Method	Operator Name	QA Name

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