Standard Operating Procedure for Multi-Layer Tablet Manufacturing Process

Department	Tablet
SOP No.	SOP/TAB/065/2025
Supersedes	SOP/TAB/065/2022
Page No.	Page 1 of 6
Issue Date	05/01/2026
Effective Date	10/01/2026
Review Date	05/01/2027

1. Purpose

To define the procedure for manufacturing multi-layer tablets, ensuring proper layer formation, uniformity, and the desired therapeutic release profile.

2. Scope

This SOP applies to the entire multi-layer tablet manufacturing process, including granulation, compression, and coating.

3. Responsibilities

• Manufacturing Personnel: Responsible for performing the multi-layer tablet manufacturing steps as outlined in this SOP.
• Quality Control (QC): Ensures the quality and uniformity of the multi-layer tablets by performing in-process testing and final product checks.
• Quality Assurance (QA): Ensures compliance with the SOP and approves the final product for release.
• Maintenance Personnel: Ensures that equipment used in the multi-layer tablet manufacturing process is calibrated and maintained.

4. Accountability

The Production Manager is accountable for ensuring that the multi-layer tablet manufacturing process is carried out according to this SOP. The QA Manager is responsible for overseeing compliance with this procedure.

5. Procedure

5.1 Preparation

1. Ensure that all ingredients are weighed accurately as per the batch record.
2. Check that the tablet press is set up correctly with the appropriate tooling for multi-layer compression.
3. Prepare the granules for each layer according to the batch record specifications. Ensure proper blending of materials for uniformity.
4. Verify that the coating solution is ready and meets the required specifications.

5.2 Layer Compression

1. Start by compressing the first layer of the tablet. Ensure that the compaction force is set correctly as per the batch record.
2. Once the first layer is complete, stop the compression cycle and load the second layer’s material onto the tablet press.
3. Compress the second layer with the same compaction force, ensuring uniform distribution.
4. Repeat the above steps for any additional layers as required by the batch record.

5.3 Monitoring During Compression

1. Monitor the tablet’s weight, thickness, and hardness at regular intervals during the compression process.
2. Ensure that the tablets meet the required specifications for each layer’s weight and thickness.
3. If the tablets do not meet specifications, adjust the compression force or material distribution and re-test.

5.4 Post-Compression Inspection

1. Inspect the tablets for any visible defects, such as cracking or uneven layering.
2. Ensure that all layers are intact and uniformly distributed.
3. Conduct a hardness test on the tablets and ensure they meet the required specifications for tablet strength.

5.5 Coating

1. Once the tablets pass the inspection, apply the coating as specified in the batch record.
2. Ensure uniform coating by adjusting spray rate, air pressure, and pan speed during the coating process.
3. After the coating is applied, inspect the tablets for coating uniformity and defects such as chipping or cracking.

5.6 Documentation

1. Document the process, including weight, thickness, and hardness measurements, in the batch record (Annexure-1).
2. Record any deviations in the deviation report (Annexure-2), including corrective actions taken.
3. Ensure all records are signed, dated, and stored in compliance with company procedures.

5.7 Equipment Maintenance

1. Perform routine maintenance on the tablet press and coating equipment to ensure they are operating properly.
2. Document all calibration and maintenance activities in the equipment 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. Deviation Report (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	Layer 1 Weight	Layer 2 Weight	Tablet Hardness	Comments
Batch 001	200 mg	180 mg	7 kg	No defects

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
10/12/2025	Batch 002	Hardness out of specification	Adjusted compression force	John Doe

Annexure-3: Equipment Maintenance Log

Maintenance Date	Equipment	Maintenance Performed	Performed By	Comments
12/12/2025	Tablet Press	Calibration and Tooling Inspection	Jane Smith	Tooling in good condition

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 Compression Settings	Improved Compression Efficiency	QA Head