Standard Operating Procedure for Homogeneity Verification in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/063/2025 |
| Supersedes | SOP/ELX/063/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standardized procedure for verifying the homogeneity of elixir formulations before filtration and packing to ensure uniform distribution of active ingredients and excipients.
2. Scope
This SOP applies to all elixir batches manufactured in the Elixir Department and requires homogeneity verification before the final product transfer for filtration and filling.
3. Responsibilities
- Production Operator:
- Collect samples from designated sampling points.
- Perform visual checks and submit samples to QC for assay or content uniformity.
- QA Officer:
- Review sampling practices and verify that homogeneity checks are performed as per SOP.
- QC Analyst:
- Conduct analytical testing of samples from different layers (top, middle, bottom).
- Report variations and approve/reject batch based on specification compliance.
4. Accountability
The Production Head is accountable for ensuring that all homogeneity verification activities are conducted and documented before batch clearance.
5. Procedure
5.1
Sampling for Homogeneity Check
- After final mixing and before bulk filtration, stop agitation for 5 minutes to settle bubbles.
- Collect samples from three levels of the batch:
- Top (upper 10%)
- Middle (center volume)
- Bottom (last 10%)
- Label each sample with location, date, batch number, and collector’s name.
5.2 Visual and Physical Examination
- Visually inspect each sample for clarity, color, presence of precipitates, and uniformity.
- Note differences in appearance between different layers (if any).
5.3 Analytical Testing
- Send samples to QC for:
- Assay of active ingredients
- Content uniformity (if required)
- Acceptable variation between top, middle, and bottom samples should not exceed ±5% from average assay result or as per specification.
5.4 Acceptance Criteria
- Appearance of all three samples should be consistent and free from particulate matter or phase separation.
- Assay values of samples must be within limits defined in the product specification sheet.
5.5 Documentation
- Record sampling and test results in the Homogeneity Verification Log (Annexure-1).
- Attach signed QC report to the BMR for final batch clearance.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QC: Quality Control
- QA: Quality Assurance
7. Documents
- Homogeneity Verification Log (Annexure-1)
- QC Test Report
- Batch Manufacturing Record
8. References
- ICH Q8(R2) – Pharmaceutical Development
- WHO GMP Guidelines – Section 7: Production
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Homogeneity Verification Log
| Date | Batch No. | Sample Point | Appearance | Assay (%) | Tested By | Verified By |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1009 | Top | Clear | 98.2 | Vikram Joshi | Sunita Reddy |
| 11/04/2025 | ELX-1009 | Middle | Clear | 98.4 | Vikram Joshi | Sunita Reddy |
| 11/04/2025 | ELX-1009 | Bottom | Clear | 98.1 | Vikram Joshi | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Issuance | New SOP | QA Head |
| 11/04/2025 | 2.0 | Updated verification points and added assay limits | Regulatory Alignment | QA Head |