Standard Operating Procedure for Post-Compression Inspection Process
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/069/2025 |
| Supersedes | SOP/TAB/069/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 25/01/2026 |
| Effective Date | 30/01/2026 |
| Review Date | 25/01/2027 |
1. Purpose
To outline the procedure for inspecting tablets post-compression, ensuring that the tablets meet the required physical and mechanical specifications.
2. Scope
This SOP applies to the inspection process immediately after tablet compression, covering visual checks, weight checks, and physical property tests.
3. Responsibilities
- Manufacturing Personnel: Responsible for performing the post-compression inspection, documenting the results, and reporting any deviations.
- Quality Control (QC): Ensures the tablets meet all required specifications for appearance, weight, and hardness. Performs sampling and further testing if necessary.
- Quality Assurance (QA): Ensures compliance with this SOP and approves the final batch for further processing or release.
4. Accountability
The Production Manager is accountable for ensuring that the post-compression inspection process is properly followed. The QA Manager is responsible for approving the final batch and ensuring that any non-conformances are addressed.
5. Procedure
5.1 Post-Compression Tablet Inspection
- After the compression process, immediately inspect a sample of tablets for defects such as cracks, chips, or uneven edges.
- Check that the tablets have the 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
- Perform a weight check on a sample of tablets from the batch using a calibrated scale.
- Ensure that the average weight of the tablets falls within the specified limits as outlined in the batch record.
- 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
- Perform a hardness test on the tablets using a tablet hardness tester to ensure they meet the required hardness specifications.
- Record the results for each tablet tested and ensure that the values fall within the acceptable range.
- If any tablets fail the hardness test, set them aside and document the failure in the batch record.
5.4 Disintegration Testing
- Perform disintegration testing on a sample of tablets according to the specifications outlined in the batch record.
- Ensure that the tablets disintegrate within the specified time limits under the prescribed test conditions.
- 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
- Perform a uniformity of dosage units test to confirm that the active ingredient is uniformly distributed throughout the batch.
- Ensure that each tablet contains the correct dose of the active ingredient within the specified limits.
- Record the results of the uniformity testing in the batch record (Annexure-3) and investigate any deviations.
5.6 Documentation and Record-Keeping
- Document all inspection results, including visual inspection, weight, hardness, and disintegration test results, in the batch record (Annexure-2).
- Record any deviations from the specifications in the deviation report (Annexure-1), along with the corrective actions taken.
- Ensure all records are signed, dated, and stored in compliance with the company’s record retention policy.
5.7 Final Approval
- 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.
- 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
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
- 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 |