Standard Operating Procedure for Incorporating Anti-Inflammatory Agents in Nasal Sprays

1) Purpose

The purpose of this SOP is to outline the process for incorporating anti-inflammatory agents into nasal spray formulations to ensure consistent dosage and therapeutic efficacy.

2) Scope

This SOP applies to all personnel involved in the formulation of nasal sprays containing anti-inflammatory agents at [Company Name].

3) Responsibilities

• Operators: Responsible for incorporating anti-inflammatory agents into the formulation and ensuring even distribution.
• QA: Verifies the concentration of anti-inflammatory agents and checks for uniformity in the formulation.

4) Procedure

4.1 Selection of Anti-Inflammatory Agents

4.1.1 Types of Anti-Inflammatory Agents

• Select appropriate anti-inflammatory agents based on the therapeutic requirements of the formulation (e.g., corticosteroids, NSAIDs).

4.1.2 Weighing of Agents

• Weigh the required amount of anti-inflammatory agents according to the formulation specifications.
• Document all weights in the batch manufacturing record (BMR).

4.2 Incorporation of Anti-Inflammatory Agents

4.2.1 Mixing

• Mix the anti-inflammatory agent into the nasal spray solution under constant stirring to ensure uniform distribution.

4.2.2 Homogenization

• Use a homogenizer if required to ensure even distribution of the active agent in the formulation.

4.3 Testing

4.3.1 Assay Testing

• Test the formulation to verify