Standard Operating Procedure for Packaging of Aerosol Products
1) Purpose
The purpose of this SOP is to provide guidelines for the packaging of aerosol products in the pharmaceutical industry, ensuring proper handling, labeling, and quality checks during packaging.
2) Scope
This SOP applies to the packaging department at [Company Name], responsible for packaging aerosol products in compliance with regulatory requirements and company standards.
3) Responsibilities
Packaging Supervisor: Oversees all packaging operations and ensures adherence to SOP.
Packaging Operators: Responsible for performing packaging tasks as per SOP.
Quality Assurance (QA) Personnel: Conducts checks and verifies packaging integrity.
4) Procedure
4.1 Preparation of Packaging Materials:
4.1.1 Ensure all packaging materials are clean, inspected, and approved for use.
4.1.2 Verify the availability of labels, leaflets, and other necessary components.
4.2 Inspection and Line Setup:
4.2.1 Inspect the packaging line for cleanliness and functionality.
4.2.2 Set up the packaging line according to the batch specifications.
4.3 Loading of Aerosol Containers:
4.3.1 Ensure containers are loaded into the packaging equipment correctly.
4.3.2 Verify the correct orientation and alignment of containers.
4.4 Labeling and Printing:
4.4.1 Apply labels to containers using automated labeling equipment.
4.4.2 Verify label accuracy, including batch number, expiry date, and product information.
4.5 Leaflet Insertion:
4.5.1 Insert leaflets or instruction sheets into packaging as required.
4.5.2 Ensure correct placement and orientation of leaflets.
4.6 Cartoning and Batch Coding:
4.6.1 Place packaged aerosols into cartons or boxes.
4.6.2 Apply batch coding and ensure traceability of each packaged unit.
4.7 Inspection and Quality Checks:
4.7.1 Perform visual inspection of packaged aerosols for defects or damage.
4.7.2 Conduct weight checks and ensure compliance with fill weight specifications.
4.8 Final Packaging and Sealing:
4.8.1 Seal cartons securely and ensure tamper-evident features are intact.
4.8.2 Prepare packaged products for storage or distribution.
5) Abbreviations, if any
QA: Quality Assurance
SOP: Standard Operating Procedure
6) Documents, if any
Packaging Records
Packaging Line Setup Checklist
7) Reference, if any
FDA Packaging Guidelines
ICH Q9: Quality Risk Management
8) SOP Version
Version 1.0
