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 Fill the aerosol containers to the specified volume.
4.4.3 Attach the valve and crimp it to the container.
4.5 Propellant Addition:
4.5.1 Add the specified propellant to the filled containers.
4.5.2 Ensure the propellant is added under controlled conditions to prevent leaks.
4.6 Sealing and Inspection:
4.6.1 Seal the filled containers and inspect for any leaks or defects.
4.6.2 Perform a leak test to ensure the integrity of the seal.
4.7 Labeling and Packaging:
4.7.1 Label the containers with the appropriate information.
4.7.2 Package the labeled containers in cartons for shipment.
5) Abbreviations, if any
BMR: Batch Manufacturing Record
QC: Quality Control
6) Documents, if any
Batch Manufacturing Record (BMR)
Quality Control Test Reports
7) Reference, if any
FDA Guidance for Industry: Manufacturing Aerosol Products
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0
