and Safety Officer: Ensures that safety protocols are followed during the inspection process, particularly in relation to handling cleaning agents and potential residues.

Maintenance Team: Assists in addressing any mechanical issues identified during the inspection and ensures the machine is in good working condition.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed, and that machines are inspected thoroughly after each cleaning cycle. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Inspection Preparation

1. Ensure that all cleaning and sanitization of the machine have been completed before the visual inspection begins. The machine should be free of any cleaning agents, solvents, and product residues.
2. Gather necessary tools for inspection, including a flashlight, magnifying glass (if required), and any other tools needed to access hard-to-reach areas.
3. Wear the appropriate Personal Protective Equipment (PPE), including gloves and safety glasses, to prevent contamination and ensure safety during the inspection process.

5.2. Conducting the Visual Inspection

1. Start the inspection by visually examining all accessible surfaces of the machine, including the exterior, interior, and all moving parts. Pay close attention to areas that come into contact with product formulations or cleaning agents.
2. Inspect the machine for the following:
   • Visible product residues or foreign particles on machine surfaces
   • Residues of cleaning agents, including any streaks or stains that indicate incomplete cleaning
   • Any signs of rust, corrosion, or damage to critical parts
   • Presence of dust, dirt, or debris in the machine’s operational areas
   • Cleanliness of seals, valves, and other parts that might trap residues
3. Use a flashlight or magnifying glass for better visibility in hard-to-reach areas such as under equipment, inside tubing, or around moving parts.
4. Inspect the machine for any signs of wear or damage that could affect its performance or cleanliness.
5. If any contamination or damage is found, document the issue and notify the maintenance team or responsible personnel for corrective action.

5.3. Post-Inspection Actions

1. If the machine passes the visual inspection, verify that it is ready for use by confirming that all necessary parts are reassembled and securely fastened.
2. If the machine fails the inspection, isolate it from the production area and report the issue to the Maintenance Team. The machine should not be used until it is cleaned again or repaired as needed.
3. Document the inspection results, including any discrepancies, corrective actions taken, and the operator’s name and date of inspection in the Visual Inspection Log (Annexure-1).

5.4. Documentation and Record-Keeping

1. Complete the Visual Inspection Log (Annexure-1) after each inspection, noting the condition of the machine, any issues found, and any corrective actions taken.
2. Ensure that all inspection records are signed and approved by the relevant personnel (Production, QC, QA) to verify that the machine is ready for the next production run.
3. Store inspection records according to the company’s document retention policy to ensure that they are available for audits and regulatory inspections.

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)

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

Machine ID	Inspection Date	Condition	Operator Name	Remarks
F-12345	06/02/2025	Passed	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 inspection criteria	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures