Standard Operating Procedure for Uniformity Testing During Tablet Compression

Department	Tablet
SOP No.	SOP/TAB/015/2025
Supersedes	SOP/TAB/015/2022
Page No.	Page 1 of 7
Issue Date	24/04/2025
Effective Date	29/04/2025
Review Date	24/04/2026

1. Purpose

This SOP outlines the procedures for performing uniformity testing during tablet compression, ensuring that tablets meet the required specifications for weight, hardness, and size consistency.

2. Scope

This SOP applies to the tablet compression process, focusing on the testing of tablet weight uniformity and other relevant parameters such as hardness and size.

3. Responsibilities

• Manufacturing Personnel: Responsible for conducting the uniformity testing of tablets during the compression process, ensuring that all tablets meet the specifications.
• Quality Control (QC): Ensures that uniformity tests are carried out according to the SOP and that any deviations are documented and investigated.
• Quality Assurance (QA): Ensures compliance with this SOP and regulatory standards, reviewing the uniformity testing results and any corrective actions taken.

4. Accountability

The Production Manager is accountable for ensuring that the uniformity testing process is conducted according to this SOP. The QA Manager is responsible for overseeing compliance and approving any corrective actions.

5. Procedure

5.1 Preparation for Uniformity Testing

1. Ensure that the tablet compression machine is set up according to the specified parameters for the batch being produced (e.g., compression force, tablet size, and speed).
2. Verify that the sampling equipment, such as balances and hardness testers, is calibrated and ready for use.
3. Obtain a sample of tablets from the compression machine at regular intervals during the production run.

5.2 Weight Uniformity Testing

1. Take a sample of at least 20 tablets from different locations in the batch to ensure representativeness.
2. Weigh each tablet individually using an electronic balance that is calibrated to ensure accurate weight measurements.
3. Calculate the average weight of the sample tablets and compare the individual weights to the average weight to check for uniformity.
4. Ensure that the weight variation falls within the acceptable range as defined by the product specifications (usually ±5% of the average weight).
5. Record the individual weights, average weight, and any deviations in the batch record (Annexure-1).

5.3 Hardness Testing

1. Using a tablet hardness tester, measure the hardness of the sample tablets. The minimum and maximum tablet hardness should be within the specifications for the product.
2. Perform the hardness test at regular intervals during the compression process to ensure consistent tablet hardness.
3. Record the hardness measurements and ensure that the results fall within the defined limits in the batch record.

5.4 Size and Thickness Testing

1. Measure the size and thickness of the sample tablets using a caliper or automated size measurement equipment.
2. Verify that the dimensions of the tablets are consistent and meet the specified size tolerance.
3. Record the size and thickness measurements in the batch record (Annexure-2).

5.5 In-Process Control

1. Monitor the tablet compression process continuously to ensure that the parameters (e.g., compression force, tablet size) are maintained within acceptable limits.
2. If deviations are observed in tablet weight, hardness, or size, adjust the compression machine settings accordingly to bring the process back into specification.
3. Notify QC and QA of any deviations and take corrective actions as necessary.

5.6 Post-Compression Inspection

1. After compression, perform a final inspection of the tablets for uniformity and ensure that all tablets meet the specified criteria for weight, hardness, and size.
2. If tablets do not meet the specifications, segregate them and perform a rework if applicable or discard the non-conforming batch according to the rework SOP.

5.7 Documentation and Record-Keeping

1. Document all uniformity testing results, including weight, hardness, and size measurements, in the batch record.
2. Ensure that any deviations or corrective actions taken are properly recorded and reviewed by QA.
3. Maintain records of all uniformity testing for future reference and regulatory compliance.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• LOD: Loss on Drying

7. Documents

1. Batch Record (Annexure-1)
2. Tablet Size and Thickness 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: Batch Record

Batch Number	Tablet Type	Weight (mg)	Hardness (kg)	Dimensions (mm)	Remarks
Batch 001	Tablet A	500	8	9.5 x 4.5	Within specifications
Batch 002	Tablet B	510	7.5	9.6 x 4.6	Minor deviation, corrected

Annexure-2: Tablet Size and Thickness Log

Batch Number	Tablet Type	Size (mm)	Thickness (mm)	Remarks
Batch 001	Tablet A	9.5	4.5	Within specifications
Batch 002	Tablet B	9.6	4.6	Minor deviation, corrected

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 Testing Parameters	Optimization of Uniformity Testing	QA Head