Standard Operating Procedure for Manufacturing Aerosol Products

1) Purpose

The purpose of this SOP is to outline the step-by-step procedure for the preparation of aerosol products in the pharmaceutical industry, ensuring consistency, quality, and compliance with regulatory standards.

2) Scope

This SOP applies to all personnel involved in the manufacturing of aerosol products at [Company Name], including preparation, mixing, filling, and packaging processes.

3) Responsibilities

Production Manager: Ensures all procedures are followed and documented accurately.
Quality Control (QC) Personnel: Conducts necessary checks and tests at each stage.
Operators: Execute the preparation steps as per the SOP.

4) Procedure

4.1 Preparation of Equipment and Work Area:
4.1.1 Ensure all equipment is clean and calibrated.
4.1.2 Verify the cleanliness of the work area and ensure it is free from contaminants.

4.2 Raw Material Inspection:
4.2.1 Inspect and verify the quality and quantity of raw materials as per the specifications.
4.2.2 Record all details in the Batch Manufacturing Record (BMR).

4.3 Preparation of the Formulation:
4.3.1 Weigh the required quantities of active ingredients and excipients.
4.3.2 Mix the ingredients in a mixer according to the specified procedure.
4.3.3 Homogenize the mixture until a uniform blend is achieved.

4.4 Filling Process:
4.4.1 Transfer the homogenized mixture to the filling machine.
4.4.2