Standard Operating Procedure for In-Process Visual Inspection of Vials
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/073/2025 |
| Supersedes | SOP/SIM/073/2022 |
| Page No. | Page 1 of 14 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
To define a systematic procedure for conducting in-process visual inspection of vials to detect particulate matter, cosmetic defects, and improper sealing during injectable manufacturing operations.
2. Scope
This SOP applies to all production personnel responsible for visual inspection of vials at the in-process stage of
sterile injectable manufacturing.
3. Responsibilities
- Production Officer: Conducts visual inspection and records observations.
- Quality Assurance Officer: Monitors inspection activity and reviews records.
- IPQA Officer: Ensures in-process checks and compliance to acceptance criteria.
4. Accountability
The Head – Production is accountable for implementation and adherence to this SOP.
5. Procedure
5.1 Preparation for Inspection
- Ensure proper gowning and entry into the controlled area as per gowning SOP.
- Ensure inspection booth lighting is functional and intensity is validated.
- Inspectors must undergo visual acuity test prior to deployment (Annexure-3).
5.2 Visual Inspection Steps
- Pick 100% of vials manually during or immediately after filling and stoppering, before final sealing.
- Hold each vial against black and white background under standard lighting conditions.
- Invert the vial gently to observe for:
- Particulate matter (fibers, glass, rubber, undissolved substances)
- Filling defects (under-filled, over-filled)
- Cosmetic defects (scratches, scuffs, labeling damage)
- Cracks, chips, or broken vials
- Visually inspect at least 5 seconds per vial.
- Reject any vial not meeting visual inspection criteria and segregate for QA disposition.
5.3 Acceptance Criteria
- No foreign particles visible to the naked eye.
- Vials must be free from defects affecting integrity or appearance.
5.4 Recording and Reporting
- Record the number of vials inspected, rejected, and accepted in Annexure-1.
- Submit report for QA verification and inclusion in batch manufacturing record.
6. Abbreviations
- SOP: Standard Operating Procedure
- IPQA: In-Process Quality Assurance
- QA: Quality Assurance
7. Documents
- Visual Inspection Log – Annexure-1
- In-Process Defect Rejection Summary – Annexure-2
- Visual Acuity Test Record – Annexure-3
8. References
- US FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
- WHO TRS 961 Annex 6: GMP for sterile pharmaceutical products
- USP <790> Visible Particulates
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Manufacturing Executive | QA Executive | Head QA |
| Department | Production | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Visual Inspection Log
| Date | Batch No. | Product Name | Inspected | Rejected | Accepted | Inspected By |
|---|---|---|---|---|---|---|
| 18/06/2025 | INJ-VX-2401 | Ceftriaxone Injection | 1000 | 12 | 988 | Rajesh Kumar |
Annexure-2: In-Process Defect Rejection Summary
| Batch No. | Defect Type | No. of Vials | Remarks |
|---|---|---|---|
| INJ-VX-2401 | Particulate Matter | 8 | Glass particle observed |
| INJ-VX-2401 | Crack in Neck | 4 | Rejected |
Annexure-3: Visual Acuity Test Record
| Inspector Name | Date of Test | Result | Validated By |
|---|---|---|---|
| Sunita Reddy | 01/06/2025 | Passed | QA Executive |
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Released | New SOP | QA Head |
| 18/06/2025 | 2.0 | Added new annexures and visual test procedure | Periodic Review | QA Head |