correct shape and size, conforming to the specifications in the batch record.

Ensure the surface of the tablet is smooth and free from visible defects such as spots or discoloration.

5.2 Weight Check

1. Perform a weight check on a sample of tablets from the batch using a calibrated scale.
2. Ensure that the average weight of the tablets falls within the specified limits as outlined in the batch record.
3. If the weight deviation exceeds the allowed range, investigate the cause and document the findings in the deviation report (Annexure-1).

5.3 Hardness Testing

1. Perform a hardness test on the tablets using a tablet hardness tester to ensure they meet the required hardness specifications.
2. Record the results for each tablet tested and ensure that the values fall within the acceptable range.
3. If any tablets fail the hardness test, set them aside and document the failure in the batch record.

5.4 Disintegration Testing

1. Perform disintegration testing on a sample of tablets according to the specifications outlined in the batch record.
2. Ensure that the tablets disintegrate within the specified time limits under the prescribed test conditions.
3. Record the results in the batch record (Annexure-2). If any tablets fail the disintegration test, document the failure and initiate an investigation.

5.5 Inspection for Uniformity of Dosage Units

1. Perform a uniformity of dosage units test to confirm that the active ingredient is uniformly distributed throughout the batch.
2. Ensure that each tablet contains the correct dose of the active ingredient within the specified limits.
3. Record the results of the uniformity testing in the batch record (Annexure-3) and investigate any deviations.

5.6 Documentation and Record-Keeping

1. Document all inspection results, including visual inspection, weight, hardness, and disintegration test results, in the batch record (Annexure-2).
2. Record any deviations from the specifications in the deviation report (Annexure-1), along with the corrective actions taken.
3. Ensure all records are signed, dated, and stored in compliance with the company’s record retention policy.

5.7 Final Approval

1. Once the post-compression inspection is complete and the tablets meet all specifications, the batch is approved for further processing or packaging by the QA Manager.
2. If any tablets fail the inspection or testing, they should be removed from the batch, and further action should be taken as per the deviation report.

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-2)
2. Deviation Report (Annexure-1)
3. Uniformity of Dosage Units Testing Report (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: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
10/12/2025	Batch 001	Weight out of specification	Adjusted compression force	John Doe

Annexure-2: Batch Record

Batch Number	Tablet Weight	Hardness	Disintegration Time	Comments
Batch 001	250 mg	8 kg	5 minutes	Within specifications

Annexure-3: Uniformity of Dosage Units Testing Report

Batch Number	Sample Size	Pass/Fail	Action Taken
Batch 001	10 tablets	Pass	None

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 Parameters	Improved Inspection Process	QA Head