Standard Operating Procedure for Formulating Nasal Sprays for Allergic Rhinitis

1) Purpose

The purpose of this SOP is to provide guidelines for formulating nasal sprays specifically designed for treating allergic rhinitis, ensuring effectiveness in reducing inflammation and nasal congestion.

2) Scope

This SOP applies to all personnel involved in the formulation of nasal sprays for allergic rhinitis at [Company Name].

3) Responsibilities

• Operators: Responsible for following the formulation guidelines to ensure correct dosage and formulation of active ingredients.
• QA: Ensures that the formulation meets the required specifications for safety and efficacy.

4) Procedure

4.1 Selection of Active Ingredients

4.1.1 Anti-Inflammatory Agents and Decongestants

• Select appropriate anti-inflammatory agents (e.g., corticosteroids) and decongestants (e.g., oxymetazoline) based on the formulation’s requirements.

4.2 Formulation Process

4.2.1 Weighing of Active Ingredients

• Weigh the required amount of anti-inflammatory agents and decongestants as per the formulation guidelines.

4.2.2 Mixing

• Mix the active ingredients into the nasal spray base solution using a magnetic stirrer or homogenizer.
• Ensure homogeneity in the mixture to avoid dosage inconsistencies.

4.3 pH and Osmolality Testing

4.3.1 Testing Procedures

• Test the pH and osmolality of the formulation to ensure they fall within the required range for nasal spray administration.

4.4 Filtration and Filling

4.4.1 Sterilization and Filtration

• Filter the formulation through a 0.22-micron filter to ensure sterility.

4.4.2 Aseptic Filling

• Fill the sterile solution into nasal spray containers using aseptic techniques.

4.5 Documentation

• Document all formulation steps, including ingredient amounts and test results, in the batch manufacturing record (BMR).

5) Abbreviations, if any

• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• pH and Osmolality Log

7) References, if any

• FDA Guidance on Nasal Spray Drug Products

8) SOP Version

Version 1.0

Annexure

pH and Osmolality Log Template

  

    
Date
    
Formulation
    
pH
    
Osmolality (mOsm/kg)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
pH Value
    
Osmolality
    
Operator Name
    
QA Name