Standard Operating Procedure for Inspecting Equipment After Each Stage of Manufacturing

Department	Tablet
SOP No.	SOP/TAB/165/2025
Supersedes	SOP/TAB/165/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for inspecting equipment after each stage of tablet manufacturing, ensuring that the equipment is free of contamination, damage, or wear that could affect the quality of the products.

2. Scope

This SOP applies to all equipment used in tablet manufacturing, including granulators, tablet presses, coating pans, and related machinery, to ensure that the equipment is properly cleaned, maintained, and inspected between each manufacturing stage.

3. Responsibilities

• Production Operator: Responsible for conducting equipment inspections after each manufacturing stage and ensuring that all equipment is clean, free of damage, and suitable for continued use.
• Quality Control (QC): Responsible for verifying that equipment inspections are carried out thoroughly and that any issues are documented and resolved.
• Quality Assurance (QA): Ensures that the equipment inspection procedure is followed in accordance with this SOP and that proper corrective actions are taken when necessary.

4. Accountability

The Production Supervisor is accountable for ensuring that all equipment is inspected at the end of each manufacturing stage. The QC Manager is responsible for verifying the inspections and ensuring compliance with this SOP.

5. Procedure

5.1 Preparation for Equipment Inspection

1. Ensure that the equipment has been powered down and cleaned according to the SOP for cleaning checks before inspection.
2. Ensure that all required inspection tools, such as visual inspection checklists, magnifying glasses, and measuring instruments, are available and ready to use.
3. Review the previous stage’s batch record and any issues reported during the previous manufacturing stage to understand what equipment requires inspection.

5.2 Conducting the Inspection

1. Inspect all equipment surfaces for visible damage, wear, or residue. Pay special attention to areas where contamination may occur, such as mixing blades, press tools, and coating pans.
2. Check for any physical damage to the equipment, such as cracks, dents, or malfunctioning components that could affect the operation or integrity of the equipment.
3. Verify that all components of the equipment are properly cleaned and free from any leftover materials, such as granulation powder, tablet residue, or coating material.
4. For tablet presses, check that punches and dies are in good condition and free of wear or damage that could affect tablet quality.
5. Ensure that all moving parts, such as motors, belts, and gears, are in proper working condition and lubricated as necessary.

5.3 Documentation of Inspection Results

1. Document the inspection results in the equipment log (Annexure-2), including the equipment ID, inspection date, and findings from the inspection.
2. Record any issues identified during the inspection, such as damaged components, cleanliness concerns, or other defects, and note if corrective actions are required.
3. If the equipment passes the inspection, sign off on the inspection form and proceed with the next manufacturing stage.
4. If issues are identified, initiate a deviation report (Annexure-1) and document the corrective actions taken.

5.4 Corrective Actions for Equipment Issues

1. If equipment issues are found during the inspection, stop the production process and inform the maintenance team to address the problem.
2. For damaged or worn-out parts, arrange for replacements or repairs to be made before resuming the manufacturing process.
3. If cleaning is inadequate, perform an additional cleaning cycle and verify cleanliness before the equipment is used for the next batch.
4. Document all corrective actions in the deviation report (Annexure-1) and review them with the QA team for approval before continuing production.

5.5 Acceptance Criteria

1. The equipment is considered acceptable if it is clean, free from damage, and fully operational after the inspection.
2. If equipment passes inspection, sign off on the inspection record and proceed to the next manufacturing stage.
3. If equipment fails inspection, corrective actions must be taken, and re-inspection should occur before production continues.

5.6 Post-Inspection Actions

1. After the inspection and any necessary corrective actions, the equipment should be ready for use in the next stage of manufacturing.
2. Ensure that all documentation is complete and filed according to the company’s document retention policy.

6. Abbreviations

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

7. Documents

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

8. References

• USP <701> – Equipment Cleaning and Maintenance Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Equipment Maintenance Standards

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation Date	Equipment ID	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Granulation Mixer	Damaged mixing blades	Replaced blades and recalibrated machine	John Doe

Annexure-2: Equipment Inspection Log

Equipment ID	Inspection Date	Condition	Tested By
Granulation Mixer	01/03/2026	Operational, no issues found	Jane Smith

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 inspection criteria	Improved equipment maintenance standards	QA Head