Standard Operating Procedure for Core Tablet Inspection Before Coating
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/018/2025 |
| Supersedes | SOP/TAB/018/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 09/05/2025 |
| Effective Date | 14/05/2025 |
| Review Date | 09/05/2026 |
1. Purpose
This SOP outlines the procedure for inspecting core tablets before they undergo coating, ensuring that the tablets meet the required specifications for uniformity, hardness, and appearance prior to the coating process.
2. Scope
This SOP applies to all core tablets that are ready to undergo the coating process, covering inspection for physical defects, weight variation, and other necessary checks to ensure coating quality.
3. Responsibilities
- Manufacturing Personnel: Responsible for inspecting core tablets for physical defects and ensuring they meet required specifications before the coating process.
- Quality Control (QC): Conducts random inspections and verifies the uniformity, appearance, and quality of core tablets before coating.
- Quality Assurance (QA): Ensures that core tablet inspection follows this SOP and that all records are appropriately documented and reviewed.
4. Accountability
The Production Manager is accountable for ensuring that the core tablet inspection is performed as per this SOP. The QA Manager is responsible for ensuring compliance with this SOP and reviewing inspection records.
5. Procedure
5.1 Preparation for Inspection
- Ensure that the core tablets have completed the compression process and are ready for coating.
- Verify that the inspection area is clean and free of any contamination that could affect tablet quality or the inspection process.
- Ensure that the necessary inspection tools, including balances, calipers, and hardness testers, are calibrated and available for use.
- Prepare the required documentation, including the batch record (Annexure-1), for recording inspection results.
5.2 Visual Inspection
- Inspect each core tablet for visible defects, such as cracks, chips, or foreign particles, which could affect the coating process or final product quality.
- Ensure that there are no discolorations or inconsistencies in tablet appearance that could affect product presentation or consumer perception.
- Verify that the tablet shape is consistent, with no irregularities such as splitting or deformation, which could lead to uneven coating or compromised integrity.
- Record any observed defects in the batch record and take corrective actions as necessary. If defects are found, segregate the affected tablets for rework or disposal according to SOP.
5.3 Size and Thickness Measurement
- Measure the size and thickness of a sample of core tablets using a caliper or automated measurement device.
- Ensure that the tablet dimensions are within the specified limits for size and thickness, as defined by the product specifications.
- Record the measurements in the batch record (Annexure-2) and ensure that all results are within the acceptable tolerance range. Any tablets outside the tolerance limits should be rejected or reworked.
5.4 Weight Uniformity Test
- Weigh a sample of core tablets using a calibrated balance to ensure that the tablet weight is within the specified limits for uniformity.
- Calculate the average weight and verify that the weight variation is within the defined range (typically ±5% of the average weight).
- Record the weight of each tablet in the batch record (Annexure-3) and ensure that the weight variation meets the required standards.
- If the weight variation exceeds the acceptable limits, segregate the affected tablets for rework or rejection and document the action taken.
5.5 Hardness Testing
- Perform hardness testing on a sample of core tablets using a tablet hardness tester.
- Ensure that the tablets meet the minimum hardness specifications required for proper handling during the coating process. The tablet hardness should be sufficient to prevent cracking or breaking during processing.
- Record the hardness measurements in the batch record and ensure that the results meet the required specifications.
- If tablets fail the hardness test, adjust the compression process or segregate the affected tablets for rework or rejection.
5.6 Uniformity Testing
- Conduct a uniformity test by sampling tablets at random from the batch and inspecting for any variations in weight, size, and appearance.
- Ensure that the tablets show no significant differences in physical attributes, such as shape, size, or color, which could affect coating uniformity.
- Record the results of the uniformity test and ensure that any variations outside of acceptable limits are addressed before proceeding to the coating process.
5.7 Final Inspection and Approval
- After completing the core tablet inspection, review the results to ensure that all tablets meet the required specifications.
- Approve the batch for coating if all parameters, including size, thickness, weight, hardness, and appearance, meet the specifications.
- If any discrepancies or defects are found, communicate with the production team and QA to determine if rework is necessary or if the batch should be rejected.
- Record all inspection results and corrective actions in the batch record and ensure that they are reviewed by the QA team.
5.8 Documentation and Record-Keeping
- Document all inspection results, including visual inspection, weight, size, hardness, and uniformity testing, in the batch record (Annexure-1).
- Ensure that all records are reviewed, signed off by the responsible personnel, and stored for regulatory compliance and future reference.
- Document any deviations from the standard inspection procedure and corrective actions taken during the inspection process.
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-1)
- Tablet Size and Thickness Log (Annexure-2)
- Tablet Weight 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 | Tablet Type | Inspection Date | Weight (mg) | Hardness (kg) | Remarks |
|---|---|---|---|---|---|
| Batch 001 | Tablet A | 10/05/2025 | 500 | 8 | Within specifications |
| Batch 002 | Tablet B | 11/05/2025 | 510 | 7.5 | Minor defect, 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 adjustment, resolved |
Annexure-3: Tablet Weight Log
| Batch Number | Tablet Type | Weight (mg) | Variation (%) | Remarks |
|---|---|---|---|---|
| Batch 001 | Tablet A | 500 | ±2% | Within specifications |
| Batch 002 | Tablet B | 510 | ±3% | Minor adjustment |
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 Tablet Inspection Criteria | Optimization of Inspection Process | QA Head |