inspections meet the required standards.

Cleaning Validation Team: Responsible for developing the cleaning validation protocol, including visual inspection criteria, and ensuring that the inspection is conducted according to the protocol.

Regulatory Affairs Team: Ensures that the visual inspection process complies with applicable regulatory standards and guidelines.

4. Accountability

The Manufacturing Manager is accountable for ensuring that visual inspections are performed according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Visual Inspection

1. Before conducting the visual inspection, ensure that the equipment has been cleaned according to the cleaning procedure outlined in the cleaning validation protocol.
2. The equipment must be fully assembled, and all surfaces that come into direct contact with the product should be accessible for inspection.
3. Ensure that proper lighting is available to allow for thorough visual inspection. Use adequate magnification tools if necessary to inspect hard-to-reach or detailed areas of the equipment.
4. The inspector should be familiar with the visual inspection criteria and be trained in identifying contaminants or residues that could impact product quality.

5.2. Conducting the Visual Inspection

1. Inspect all surfaces of the equipment that come into contact with the product. This includes:
   • Filling nozzles, pumps, and valves
   • Containers, tubes, or chambers where the product is held
   • Any surfaces where product buildup, cleaning agent residues, or contamination could occur
2. During the visual inspection, look for:
   • Visible residues, such as product, cleaning agents, or other contaminants
   • Signs of improper cleaning, such as discoloration, streaks, or foreign particles
   • Excessive moisture or cleaning agent residue that could impact the next production run
   • Any visible wear, corrosion, or damage to the equipment that could affect cleanliness or product quality
3. If any residue or contamination is observed, further cleaning should be performed, and the equipment should be re-inspected until it meets the required cleanliness standards.

5.3. Documenting the Visual Inspection

1. All visual inspections should be documented in the Visual Inspection Report (Annexure-1). The report should include:
   • Batch number and equipment cleaned
   • Date and time of the inspection
   • Inspection results (pass or fail)
   • Details of any observed residues or contamination
   • Corrective actions taken if necessary
2. The inspector should sign and date the report to confirm that the inspection was conducted properly.
3. The Visual Inspection Report should be reviewed and approved by the QA team to ensure that it complies with the cleaning validation requirements.

5.4. Corrective Actions for Failed Inspections

1. If the visual inspection reveals that the equipment is not clean, the following corrective actions should be taken:
   • Re-clean the equipment according to the cleaning procedure specified in the cleaning validation protocol.
   • Ensure that the cleaning process is adjusted to address the issues identified during the inspection (e.g., improving cleaning procedures, increasing cleaning time, or adjusting cleaning agents).
   • Reinspect the equipment after the corrective actions are implemented to verify that it meets the cleanliness standards.
2. If the equipment still fails the visual inspection after corrective actions are taken, further investigation should be conducted to determine the cause and identify any additional steps needed to ensure effective cleaning.

5.5. Review and Approval of Visual Inspection Results

1. Once the visual inspection is complete and documented, the QA team should review the results to ensure that the inspection was conducted properly and that the equipment meets the required cleanliness standards.
2. The QA team should approve the inspection results if the equipment is clean and suitable for the next production run. If there are issues or deviations, the QA team should ensure that corrective actions are taken before proceeding with production.
3. The Visual Inspection Report should be stored in the appropriate record-keeping system, either electronically or in paper format, for future reference and regulatory inspections.

5.6. Revalidation of Visual Inspection Process

1. If changes are made to the cleaning process or if issues are identified during visual inspections, the visual inspection process should be revalidated to ensure its continued effectiveness.
2. Revalidation should include a review of the inspection criteria, sampling points, and inspection methods to ensure they remain appropriate for the revalidated cleaning process.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action

7. Documents

1. Visual Inspection Report (Annexure-1)
2. Deviation Log (Annexure-2)

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
• International Council for Harmonisation (ICH) Guidelines

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 Report

Batch Number	Test Date	Inspection Results	Corrective Actions	Remarks
Batch-001	10/02/2025	Pass	None	All equipment clean and ready for production

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Residue observed on nozzle	Re-cleaned nozzle	Rajesh Patel	Completed

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 procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures