Standard Operating Procedure for Visual Inspection of Packed Injectable Products
| Department | Packaging |
|---|---|
| SOP No. | SOP/PKG/192/2025 |
| Supersedes | SOP/PKG/192/2022 |
| Page No. | Page 1 of 14 |
| Issue Date | 24/06/2025 |
| Effective Date | 26/06/2025 |
| Review Date | 24/06/2026 |
1. Purpose
To define the procedure for performing visual inspection of packed injectable products to ensure their conformance to approved specifications, freedom from defects, and readiness for batch release and market distribution.
2. Scope
This SOP applies to all packed injectable products (vials, ampoules,
and prefilled syringes) post-secondary packaging stage and before storage or dispatch in the Packaging Department.
3. Responsibilities
- Packaging Operators: Conduct visual inspection as per training and guidelines.
- Packaging Supervisors: Monitor compliance and complete inspection documentation.
- QA Officers: Verify inspection results and perform sample rechecks.
4. Accountability
The Head of Packaging is accountable for ensuring that visual inspection is completed and documented for each batch before batch release.
5. Procedure
5.1 Preparation for Inspection
- Ensure area cleanliness and lighting conditions meet SOP/ENV/114/2024 requirements.
- Verify that inspectors are qualified and trained for visual inspection tasks.
- Ensure all products to be inspected are arranged in labeled crates or trays with batch details.
5.2 Visual Inspection Criteria
- Inspect outer cartons for:
- Correct batch coding, printing clarity, and label alignment
- No damage, crushed corners, or soiling
- Check inner boxes for:
- Correct leaflet inclusion (if applicable)
- Seal integrity and tamper-evidence
- Inspect for:
- Presence of correct product labeling
- Uniformity of packing style
- No misprints or mixed components
5.3 Inspection Methodology
- Perform 100% visual inspection for critical batches or as per QRM-based sampling plan (Annexure-2).
- Use the Inspection Log Sheet (Annexure-1) to document inspection results.
- Flag and segregate defective units in the “Rejected Material Bin.”
- Defects to look for:
- Incorrect label, wrong batch number
- Physical damage or leakage in primary packaging
- Missing leaflet (if applicable)
- Illegible or smudged print
- Instruct QA for re-inspection if rejection rate exceeds control threshold (e.g., 1%).
5.4 Documentation
- All inspected trays shall be tagged with “Inspected by” slip (signed and dated).
- Record inspection activity in batch packaging records.
- Report any deviation to QA using deviation form (SOP/QA/112/2023).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QRM: Quality Risk Management
7. Documents
- Inspection Log Sheet – Annexure-1
- Sampling Plan for Visual Inspection – Annexure-2
8. References
- ICH Q9: Quality Risk Management
- WHO TRS 986 Annex 2: GMP for Pharmaceutical Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Packaging Officer | QA Executive | Head QA |
| Department | Packaging | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Inspection Log Sheet
| Batch No. | Date | Product | No. of Units Inspected | Defects Found | Inspector Name | Remarks |
|---|---|---|---|---|---|---|
| BN2025A15 | 24/06/2025 | Ceftriaxone 1g | 2500 | 3 | Sunita Reddy | OK |
Annexure-2: Sampling Plan for Visual Inspection
| Batch Size | Sample Size | Acceptance Criteria | Rejection Criteria |
|---|---|---|---|
| Up to 5000 | 500 | ≤ 5 Defects | > 5 Defects |
| 5001–10000 | 800 | ≤ 8 Defects | > 8 Defects |
| 10001 and above | 1250 | ≤ 10 Defects | > 10 Defects |
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial release | New SOP | Head QA |
| 24/06/2025 | 2.0 | Updated sampling plan and documentation procedure | GMP alignment | Head QA |