Standard Operating Procedure for Visual Inspection of Prepared Elixirs
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/090/2025 |
| Supersedes | SOP/ELX/090/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for conducting visual inspection of prepared elixir solutions prior to filtration, filling, or packaging to ensure product quality, appearance, and compliance with specifications.
2. Scope
This SOP is applicable to all batches of elixir formulations manufactured in the Elixir Department before they are transferred to storage tanks, filters, or packaging lines.
3. Responsibilities
- Production Operator:
- Conduct visual inspection under appropriate lighting conditions.
- Document observations and report abnormalities immediately.
- Production Supervisor:
- Verify inspection records and authorize release to next stage.
- QA Officer:
- Perform random verification and ensure compliance with visual quality standards.
4. Accountability
The Head of Production is accountable for ensuring visual inspection is performed for every batch and that only visually conforming product is processed further.
5. Procedure
5.1 Preparation for Inspection
- Ensure the product is completely mixed
and the tank is at rest for at least 5 minutes prior to inspection.
Perform inspection under white light and black background to detect particles, fibers, undissolved matter, and discoloration.
Use clean, transparent sampling jars for sample observation.
5.2 Visual Inspection Parameters
- Inspect for:
- Color consistency
- Absence of floating particles
- Absence of precipitates or sedimentation
- No visible microbial contamination
- Clarity and homogeneity
- Use standard reference solution for comparison where applicable.
5.3 Documentation and Reporting
- Record all observations in the Visual Inspection Log (Annexure-1).
- If any abnormality is observed, hold the batch and inform QA for further evaluation.
- Attach visual inspection results to the Batch Manufacturing Record (BMR).
5.4 QA Verification
- QA to perform at least one random verification per batch or campaign.
- QA shall sign off the Visual Inspection Log before batch proceeds to filtration or packaging.
5.5 Acceptance Criteria
- The solution must be clear or as per product specification.
- No visible particulate, discoloration, or microbial growth.
- Color should match the approved reference sample (if available).
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
7. Documents
- Visual Inspection Log (Annexure-1)
- Reference Standard File (if applicable)
- Batch Manufacturing Record (BMR)
8. References
- 21 CFR Part 211.160 – General Requirements (Testing and Inspection)
- WHO TRS 1010 – GMP for Pharmaceutical Products
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 No. | Inspection Time | Inspector | Observation | Remarks | QA Verified |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1029 | 03:45 PM | Rajesh Kumar | Clear, pale yellow, no particles | Accepted | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Included QA verification and reference sample comparison | GMP Enhancement | QA Head |