Standard Operating Procedure for Checking Bulk Appearance and Clarity in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/102/2025 |
| Supersedes | SOP/ELX/102/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To outline the procedure for checking the appearance and clarity of bulk elixir before it proceeds for filtration, storage, or bottling, ensuring compliance with visual and organoleptic quality parameters.
2. Scope
This SOP applies to all elixir batches manufactured in the Elixir Department that require visual inspection for appearance, color, clarity, and the presence of visible particles.
3. Responsibilities
- Production Operator:
- Collect samples and perform initial visual checks.
- Production Supervisor:
- Verify appearance results and document observations in the BMR.
- QA Officer:
- Confirm observations, verify specifications, and approve the batch for the next stage.
4. Accountability
The Head of Quality Assurance is accountable for ensuring that all bulk elixir batches are evaluated for appearance and clarity before release for further processing.
5. Procedure
5.1 Sample Collection
- After final mixing, collect 100
mL of bulk solution using a sanitized sampling beaker.
Ensure that the sample is representative and taken from the middle layer of the tank.
Transfer the sample into a clean, transparent glass bottle for visual examination.
5.2 Visual Inspection
- Inspect the sample against white and black backgrounds under adequate lighting (minimum 600 lux).
- Observe and record the following attributes:
- Appearance: Clear, colored, or turbid
- Color: As per product specification (e.g., pink, yellow)
- Clarity: Clear / Slightly hazy / Opaque
- Visible Particles: Absent / Present (e.g., fibers, foreign matter)
- If any visible particulate matter or turbidity is observed, escalate for re-filtration or investigation.
5.3 Specification Comparison
- Compare observed characteristics with approved specification limits as mentioned in the product master formula or QC specification.
- Record any deviations in the Appearance and Clarity Log (Annexure-1) and report to QA immediately.
5.4 Approval and Documentation
- QA shall verify the recorded results and sign off if the batch complies with clarity and appearance requirements.
- Production shall record details in the BMR and attach the Appearance and Clarity Log (Annexure-1).
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
7. Documents
- Appearance and Clarity Log (Annexure-1)
- Batch Manufacturing Record (BMR)
8. References
- Pharmacopoeial Guidelines (IP, USP, BP)
- WHO TRS 986 – GMP for Pharmaceutical Products
- 21 CFR Part 211.160 – General Requirements for Laboratory Controls
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Appearance and Clarity Log
| Date | Batch No. | Appearance | Color | Clarity | Particles | Observed By | QA Verified |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1041 | Clear | Pale Yellow | Clear | Absent | Rajesh Kumar | 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 | Refined inspection process and included visual backgrounds | Visual QC Enhancement | QA Head |