Procedure for Visual Inspection During Packing
| Department | Packaging/Quality Assurance (QA)/Production |
|---|---|
| SOP No. | SOP/Ointment/098 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting visual inspection during the packaging of ointments. This ensures product integrity, defect-free packaging, and compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for visual inspection of packaging components and final packed products.
3. Responsibilities
- Packaging Operator: Conducts visual inspection of packaging materials and final packed products.
- Packaging Supervisor: Monitors the inspection process and ensures defective units are removed.
- Quality Assurance (QA) Officer: Verifies inspection records and ensures compliance.
- QA Manager: Approves the final inspected batch before distribution.
4. Accountability
The QA and Packaging Managers are accountable for ensuring that all packaged products undergo thorough visual inspection before batch release.
5. Procedure
5.1 Pre-Inspection Preparations
- Ensure that the packaging area is clean and free from contaminants.
- Confirm that proper lighting conditions are available for visual inspection.
- Verify that only trained personnel perform visual inspection tasks.
5.2 Visual Inspection Parameters
- Check packaging materials (cartons, tubes, labels) for any visible defects.
- Inspect printed batch numbers, expiry dates, and barcodes for accuracy.
- Ensure that sealing and tamper-evident features are intact.
- Look for signs of leakage, dents, misalignment, or incorrect labeling.
5.3 Defect Classification
- Critical Defects: Issues that affect product safety or compliance (e.g., missing labels, incorrect expiry date).
- Major Defects: Issues that affect usability but not safety (e.g., smudged print, minor carton damage).
- Minor Defects: Cosmetic issues that do not affect function (e.g., minor label misalignment).
5.4 Handling of Defective Units
- Segregate defective units and document reasons for rejection.
- Investigate the cause of defects and take corrective actions.
- Dispose of or rework defective units as per QA decision.
5.5 Documentation and Approval
- Record visual inspection details in the Inspection Log.
- QA must review and approve the inspected batch before release.
- Ensure traceability of inspected batches for regulatory compliance.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BPR – Batch Packaging Record
7. Documents
- Visual Inspection Log (Annexure-1)
- Final Inspection Approval Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q10 – Pharmaceutical Quality System
- USP <41> – Weights and Balances
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Visual Inspection Log
| Date | Batch Number | Inspection Parameter | Inspected By | Result | Remarks |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Label Accuracy | QA Officer | Pass | Compliant |
| 01/02/2025 | OINT-102 | Seal Integrity | QA Officer | Pass | Compliant |
Annexure-2: Final Inspection Approval Report
| Date | Batch Number | Inspection Component | Verified By | Approval Status |
|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Cartons, Labels, Tubes | QA Manager | Approved |
| 02/02/2025 | OINT-102 | Seals, Barcode | QA Manager | Approved |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |