(PPE) and follow safety protocols when handling containers.

Maintenance Team: Responsible for ensuring that any inspection equipment (e.g., automated visual inspection machines) is calibrated and maintained for proper function.

4. Accountability

The Manufacturing Manager is accountable for ensuring that visual inspection is conducted for all aerosol containers in compliance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Inspection Preparation

1. Ensure that aerosol containers are positioned correctly on the inspection line and are ready for visual inspection after the filling and sealing processes are complete.
2. Prepare necessary equipment for inspection, including:
   • Visual inspection stations (manual or automated)
   • Lighting systems to ensure proper visibility of defects
   • Calibrated measuring tools for checking container dimensions (if required)
   • PPE, including gloves, goggles, and lab coats
3. Ensure that all personnel are trained in visual inspection techniques and that they are familiar with the defects to look for (e.g., dents, scratches, leaks, improper sealing).

5.2. Conducting the Visual Inspection

1. Begin the visual inspection process and examine each aerosol container for the following:
   • Physical Defects: Check for visible dents, scratches, cracks, or other physical deformities on the can.
   • Seal Integrity: Verify that the valve is securely attached and that there are no signs of leakage around the valve area.
   • Labeling: Ensure that labels are correctly applied, properly aligned, and free from defects such as misprints or smudging.
   • Corrosion or Rust: Check for any signs of corrosion or rust, especially around the seam and crimping areas, which may compromise the container’s integrity.
   • Can Dimensions: Check that the dimensions of the can conform to the required specifications (e.g., height, diameter).
2. For automated systems:
   • Ensure that the automated visual inspection system is functioning properly, with clear imaging and defect detection capabilities.
   • Monitor the system’s output to ensure that it is accurately identifying defects and sorting out non-conforming containers.
3. If performing manual inspections:
   • Inspect each can carefully and document any defects found on the Visual Inspection Log (Annexure-1).
   • Use standardized checklists or templates to ensure that all areas of the container are thoroughly inspected.

5.3. Post-Inspection Actions

1. If a can passes the visual inspection:
   • Proceed with the next stage in the production process, ensuring that only conforming containers are released for packing and shipping.
   • Document the results in the Visual Inspection Log (Annexure-1), noting the total number of containers inspected and the number of defects found (if any).
2. If a can fails the visual inspection:
   • Remove the non-conforming can from the production line and label it as “non-conforming.”
   • Identify the specific defect (e.g., dent, mislabeling, leak) and record it in the Visual Inspection Log (Annexure-1).
   • Notify the QC team and take corrective actions as needed (e.g., reworking, adjusting machine settings, replacing defective materials).

5.4. Calibration and Maintenance of Equipment

1. Ensure that visual inspection equipment (manual or automated) is calibrated at regular intervals to ensure accuracy.
2. Perform routine maintenance on all visual inspection systems, including cleaning, checking for mechanical wear, and ensuring that imaging equipment is functioning properly.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-2) and the Equipment Maintenance Log (Annexure-3).

5.5. Documentation and Record-Keeping

1. Document all visual inspection activities, including the container ID, test date, operator name, defects found, and corrective actions taken, in the Visual Inspection Log (Annexure-1).
2. Ensure that the results are reviewed by the QC team to confirm that all containers meet the required quality standards.
3. Store all records in the document management system, ensuring they are available for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in the visual inspection process wear the appropriate PPE to prevent exposure to aerosols or harmful substances.
2. Follow all safety guidelines for handling aerosol containers, including avoiding exposure to pressurized cans and ensuring proper handling during inspection.
3. Dispose of any non-conforming aerosol containers and other waste materials in accordance with environmental and safety regulations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Visual Inspection Log (Annexure-1)
2. Corrective Action Log (Annexure-2)
3. Equipment Calibration Log (Annexure-3)
4. Equipment Maintenance Log (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Visual Inspection Log

Can ID	Test Date	Defects Found	Operator Name	Remarks
C-12345	06/02/2025	None	Rajesh Patel	No issues found

Annexure-2: Corrective Action Log

Can ID	Issue Date	Issue Description	Corrective Action	Operator Name
C-12346	06/02/2025	Mislabeling	Reworked labeling	Rajesh Patel

Annexure-3: Equipment Calibration Log

Equipment ID	Calibration Date	Calibration Results	Operator Name	Remarks
VISUAL-001	06/02/2025	Pass	Rajesh Patel	No adjustments required

Annexure-4: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
VISUAL-001	06/02/2025	Cleaned and calibrated	Rajesh Patel	No issues found

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated visual inspection procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures