Standard Operating Procedure for Visual Inspection of Packed Tablets
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/236/2025 |
| Supersedes | SOP/TAB/236/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/04/2026 |
| Effective Date | 06/04/2026 |
| Review Date | 01/04/2027 |
1. Purpose
This SOP describes the procedure for visual inspection of packed tablets to ensure that they meet the required quality standards. The goal is to detect any defects such as cracks, broken tablets, incorrect labeling, or packaging issues before the products are released for distribution.
2. Scope
This SOP applies to the visual inspection process for all tablet products after they have been packed and sealed. It covers the inspection of the blister packs, bottles, or any other packaging formats used for tablet products.
3. Responsibilities
- Production Manager: Ensures that the visual inspection process is conducted properly and that all necessary personnel are trained and equipped.
- Packing Line Operator: Performs the initial visual inspection during the packing process and flags any issues for further review.
- Quality Control (QC) Personnel: Conducts a secondary inspection to verify the integrity of the tablets, ensuring they meet all quality standards before being released for distribution.
- Maintenance Personnel: Ensures that all equipment involved in the packing and inspection process is properly maintained and calibrated.
4. Accountability
The Production Manager is accountable for ensuring that visual inspections are carried out according to this SOP. The QC department is responsible for ensuring that the inspection results are documented and that any defective products are handled appropriately.
5. Procedure
5.1 Preparation for Visual Inspection
- Ensure that the packaging area is clean and properly lit to allow clear visibility during the inspection process (Annexure-1).
- Confirm that the packing machine has been calibrated and is functioning correctly (Annexure-2).
- Set up the inspection station with necessary tools such as magnifying glasses, quality control forms, and pens (Annexure-3).
- Verify that personnel performing the inspection have received the appropriate training and are familiar with the product specifications (Annexure-4).
5.2 Visual Inspection Process
- Inspect each blister pack, bottle, or packaging format for visible defects such as cracks, broken tablets, misprints, or improper sealing (Annexure-5).
- Check the batch number, expiry date, and other required labeling to ensure that all information is correct and legible (Annexure-6).
- Examine the integrity of the packaging material, ensuring that there are no holes, tears, or leaks (Annexure-7).
- Flag any tablets that exhibit physical defects such as discoloration, chips, or incomplete tablets (Annexure-8).
- Record the inspection results and any defects found in the inspection log (Annexure-9).
5.3 Handling Defective Tablets
- Segregate all defective products and label them as “Rejects” (Annexure-10).
- Document the defect type, quantity, and batch number in the defect log (Annexure-11).
- Notify the QC team to perform further tests on the rejected products, if necessary, to identify the root cause of the defect (Annexure-12).
- Investigate the cause of the defects, such as equipment malfunctions, packaging issues, or raw material problems (Annexure-13).
- Implement corrective actions, such as adjusting equipment settings or replacing defective packaging materials (Annexure-14).
5.4 Final Approval
- Once the visual inspection is completed, submit the batch for final approval by the QA department (Annexure-15).
- Ensure that all inspection logs are signed and dated by the QC inspector and the responsible supervisor (Annexure-16).
- Release the batch for distribution if it meets all visual inspection standards, or place it on hold if defects are found (Annexure-17).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- GMP: Good Manufacturing Practice
7. Documents
- Inspection Log (Annexure-5)
- Defect Log (Annexure-9)
- Corrective Action Log (Annexure-14)
- Final Approval Log (Annexure-15)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- USP <1079> – Good Storage and Distribution Practices
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Packaging Area Setup Checklist
| Item | Condition | Remarks |
|---|---|---|
| Lighting | Good | Ensures clear visibility |
| Work Area Cleanliness | Clean | Free of debris |
Annexure-2: Packing Machine Calibration Log
| Machine | Calibration Date | Next Calibration Due | Operator |
|---|---|---|---|
| Sealing Machine | 01/04/2026 | 01/04/2027 | John Doe |
Annexure-3: Inspection Tools and Equipment Log
| Tool | Condition | Last Calibrated | Operator |
|---|---|---|---|
| Magnifying Glass | Good | 01/04/2026 | Jane Smith |