Standard Operating Procedure for Tablet Compression Process

Department	Tablet
SOP No.	SOP/TAB/007/2025
Supersedes	SOP/TAB/007/2022
Page No.	Page 1 of 8
Issue Date	15/03/2025
Effective Date	20/03/2025
Review Date	15/03/2026

1. Purpose

To establish a standardized procedure for the tablet compression process, ensuring that tablets are compressed to the required weight, hardness, and other quality specifications.

2. Scope

This SOP applies to the tablet compression process, including machine setup, tablet compression, and monitoring of tablet quality during the process.

3. Responsibilities

• Manufacturing Personnel: Responsible for setting up and operating the tablet compression machine, ensuring proper tablet compression parameters are followed.
• Quality Control (QC): Responsible for performing in-process checks on tablet weight, hardness, and other specifications during the compression process.
• Quality Assurance (QA): Responsible for overseeing the compliance with this SOP and ensuring the tablet compression process meets regulatory and internal quality standards.

4. Accountability

The Production Manager is accountable for the proper execution of the tablet compression process. The QA Manager ensures compliance with this SOP and regulatory standards.

5. Procedure

5.1 Tablet Compression Machine Setup

1. Ensure the tablet compression machine is clean and free of any previous product residue.
2. Verify that the die and punch sizes correspond to the specifications required for the current batch.
3. Check that the tablet press is calibrated and operational, including ensuring proper pressure and speed settings are in place.
4. Ensure all settings, such as tablet weight, hardness, and thickness, are input into the system and aligned with the formulation specifications.

5.2 Loading Granules into Compression Machine

1. Transfer the lubricated granules into the hopper of the tablet compression machine.
2. Ensure the granules are evenly distributed in the hopper, preventing blockages or uneven filling of the tablet dies.
3. Check that the granules have the correct consistency and moisture content for tablet compression. If necessary, adjust the formulation or parameters before loading.

5.3 Tablet Compression

1. Start the tablet compression process and monitor the machine to ensure tablets are being compressed properly.
2. Adjust the compression pressure if necessary to achieve the desired tablet hardness. Maintain consistency in the tablet weight and size throughout the process.
3. Ensure that the tablet edges are smooth and free from defects such as capping or lamination.
4. Perform regular checks on the compression force to ensure it remains within the specified range.

5.4 In-Process Quality Control

1. Monitor the tablet compression process regularly, checking the weight, hardness, and appearance of tablets at defined intervals.
2. Perform in-process checks for tablet weight, hardness, and thickness using calibrated instruments, and compare with specifications.
3. Take sample tablets for disintegration and dissolution testing, if required by the formulation guidelines.
4. Record all results from in-process quality checks in the batch record (Annexure-1).
5. If any abnormalities are detected, adjust machine parameters accordingly and document any deviations from the standard process.

5.5 Monitoring Tablet Quality

1. During the compression process, monitor tablet characteristics such as weight variation, hardness, and thickness to ensure consistency.
2. Ensure that tablets meet the required hardness range as per the formulation requirements.
3. Document any corrective actions taken if the tablet quality does not meet specifications.

5.6 Tablet Collection and Storage

1. Once the tablets are compressed, collect them in designated bins or containers for the next processing step (e.g., coating or packaging).
2. Ensure that tablets are stored in a clean, dry environment to avoid contamination or degradation before further processing.

5.7 Equipment Shutdown and Cleaning

1. Once tablet compression is complete, shut down the machine and clean it according to the approved cleaning SOP.
2. Ensure that all parts that come into contact with the product are thoroughly cleaned to prevent cross-contamination between batches.

5.8 Documentation and Record-Keeping

1. Document all tablet compression parameters, including compression pressure, speed, tablet weight, and hardness, in the batch record.
2. Sign off on the batch record to confirm the completion of the tablet compression process.
3. Maintain detailed records of in-process checks, deviations, and any corrective actions taken during the tablet compression process.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CoA: Certificate of Analysis

7. Documents

1. Tablet Compression Batch Record (Annexure-1)
2. Tablet Quality Control Log (Annexure-2)

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: Tablet Compression Batch Record

Batch Number	Tablet Type	Compression Pressure	Tablet Weight	Tablet Hardness	Remarks
Batch 001	Tablet A	50 kN	500 mg	8 kg	Within specifications
Batch 002	Tablet B	55 kN	510 mg	8.5 kg	Minor deviation in weight

Annexure-2: Tablet Quality Control Log

Batch Number	Test Performed	Result	Test Date	QC Personnel
Batch 001	Tablet Weight	Pass	15/03/2025	John Doe
Batch 002	Tablet Hardness	Pass	16/03/2025	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 Compression Parameters	Standardization of Tablet Compression Process	QA Head