compression tooling is properly inspected and cleaned as per this SOP. The QA Manager is responsible for reviewing the documentation and ensuring compliance with regulatory standards.

5. Procedure

5.1 Pre-Inspection and Pre-Cleaning Preparation

1. Ensure that the compression machine is powered off and the tooling is removed safely according to the machine’s shut-down procedures.
2. Wear appropriate personal protective equipment (PPE) such as gloves and safety glasses before handling the tooling.
3. Ensure that the inspection and cleaning areas are clean and well-organized, with all necessary tools and cleaning agents readily available.
4. Check the batch records for any tooling-related issues reported during the previous batch to address any specific concerns during the inspection.

5.2 Compression Tooling Inspection

1. Inspect each die and punch for any visible signs of wear, damage, or contamination.
2. Check for any chips, cracks, or dullness on the surface of the tooling, which could affect tablet formation.
3. Ensure that the tooling is free from any product residues or contamination from previous batches. Inspect the tooling for any powder buildup or oils.
4. Verify that the tooling is properly aligned and that all components fit securely without any looseness or misalignment.
5. If any defects or damage are found, remove the tooling from service and report the issue to the Maintenance Supervisor for repairs or replacement.

5.3 Compression Tooling Cleaning

1. Remove any loose product residues from the tooling using an appropriate brush or air gun. Ensure that no debris is left on the surfaces.
2. Clean the tooling using an approved cleaning solution or solvent that is compatible with the material of the tooling. Ensure the cleaning agent effectively removes product residues and prevents corrosion.
3. For stubborn residues, use a soft abrasive pad or cloth to gently scrub the surface of the tooling without causing damage.
4. Rinse the tooling thoroughly to remove any cleaning solution or solvent. Ensure that no residue from the cleaning agent remains on the tooling surface.
5. Dry the tooling completely using a clean, lint-free cloth or allow it to air dry in a clean environment.
6. After cleaning, inspect the tooling again to ensure that all residues have been removed and that no damage has occurred during cleaning.

5.4 Lubrication and Reassembly

1. If necessary, apply a thin layer of approved lubricant to the tooling to prevent sticking and reduce wear during the next compression cycle. Ensure that only a small amount of lubricant is used to avoid contamination of the tablet product.
2. Reassemble the cleaned and lubricated tooling, ensuring that all components are securely fitted and properly aligned according to the manufacturer’s specifications.
3. Ensure that all tools used in the cleaning and lubrication process are also cleaned and stored properly after use to prevent contamination.

5.5 Post-Cleaning Inspection

1. Conduct a final inspection of the cleaned and reassembled tooling to verify that it is free from defects, contamination, and residues.
2. Ensure that the tooling is properly labeled with a “cleaned and ready for use” tag to indicate it is ready for the next production run.
3. Document all inspection and cleaning activities, including any defects or corrective actions taken, in the batch record (Annexure-1).

5.6 Documentation and Record-Keeping

1. Ensure that all inspection and cleaning activities are properly documented in the tooling inspection log (Annexure-2), including the date of inspection, findings, and any corrective actions taken.
2. Ensure that the batch record includes all relevant tooling inspection and cleaning information, as well as any deviations or issues encountered.
3. Review and approve the completed records to ensure compliance with this SOP and regulatory standards.
4. Store the inspection and cleaning records for future reference and regulatory compliance audits.

5.7 Equipment Shutdown and Maintenance

1. After completing the inspection and cleaning process, shut down the equipment according to the SOP for machine shutdown.
2. Perform routine maintenance checks on the compression machine and tooling storage areas to ensure that they are properly maintained and free of contamination.
3. Document any maintenance performed on the equipment and tooling in the maintenance log (Annexure-3).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Batch Record (Annexure-1)
2. Tooling Inspection Log (Annexure-2)
3. Equipment Maintenance Log (Annexure-3)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number	Tablet Type	Tooling Condition	Cleaning Date	Remarks
Batch 001	Tablet A	Good	01/06/2025	Inspection and cleaning completed
Batch 002	Tablet B	Minor Wear	02/06/2025	Replaced damaged punch

Annexure-2: Tooling Inspection Log

Inspection Date	Tooling Type	Condition	Corrective Action Taken	Remarks
01/06/2025	Die	Good	None	Ready for use
02/06/2025	Punch	Minor Wear	Replaced	Replaced punch before use

Annexure-3: Equipment Maintenance Log

Maintenance Date	Equipment	Maintenance Type	Performed By	Remarks
01/06/2025	Compression Machine	Routine Maintenance	John Doe	No issues found
15/06/2025	Compression Machine	Tooling Replacement	Jane Smith	Punch replaced due to wear

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Tooling Inspection Guidelines	Tooling Wear Monitoring	QA Head