Standard Operating Procedure for Testing Suspended Particles in Elixir Formulations
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/220/2025 |
| Supersedes | SOP/ELX/220/2022 |
| 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 a standardized procedure for detecting and quantifying visible and sub-visible suspended particles in elixir formulations to ensure compliance with pharmacopoeial standards and product quality.
2. Scope
This SOP applies to all batches of elixirs produced and tested by the Quality Control Department for the presence of suspended particulate matter as part of finished product testing.
3. Responsibilities
- QC Analyst:
- Perform the test using visual and instrumental methods.
- Document findings in logbooks and report deviations.
- QC Supervisor:
- Verify results and ensure the test is performed under controlled environmental conditions.
- QA Officer:
- Review the report and approve test results for batch release.
4. Accountability
The QC Head is accountable for the execution and evaluation of this test. The QA Head ensures adherence to specifications and regulatory compliance.
5. Procedure
5.1 Sample Preparation
- Take a
representative 25–50 mL sample of the elixir in a clean, transparent, colorless glass container.
Ensure the sample is well mixed and free from bubbles or froth.
Allow the sample to rest for 2–3 minutes before evaluation.
5.2 Visual Inspection
- Perform the test under uniform illumination (approx. 1000 lux) in a clean, dust-free area.
- Place the sample against a black and white background and observe at eye level.
- Slowly rotate the sample and examine for:
- Floating or suspended particles
- Settled precipitate
- Crystals, fibers, or other visible contaminants
- Record findings and classify the sample as:
- Clear: No visible suspended matter
- Slightly Suspended: Few non-uniform particles visible
- Suspended: Definite visible particulate matter
5.3 Optional Instrumental Method (If Applicable)
- Use a particle counter or turbidimeter if method validation supports it.
- Record particle size distribution and count (e.g., particles >10 µm and >25 µm).
- Follow USP <788> or similar method for interpretation if applied.
5.4 Acceptance Criteria
- No visible suspended matter should be present.
- If slight particles are seen, ensure justification exists in product specification and verify absence of microbial/fungal growth.
- Any unexpected precipitate, sedimentation, or contamination shall lead to batch investigation.
5.5 Documentation
- Record observations in the Suspended Particles Inspection Logbook (Annexure-1).
- Attach any images or instrument reports (if used) to the BMR.
6. Abbreviations
- SOP: Standard Operating Procedure
- QC: Quality Control
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- µm: Micrometer
7. Documents
- Suspended Particles Inspection Logbook (Annexure-1)
- Instrument Calibration Certificates (if applicable)
- Batch Manufacturing Record (BMR)
8. References
- USP General Chapter <790> – Visible Particulates in Injections (adapted for orals)
- USP General Chapter <788> – Particulate Matter in Injections (for particle size count)
- 21 CFR Part 211.160 – 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: Suspended Particles Inspection Logbook
| Date | Batch No. | Observation | Classification | Tested By | Verified By |
|---|---|---|---|---|---|
| 11/04/2025 | ELX-0425-038 | No particles observed | Clear | Rajesh Kumar | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Included optional particle size testing | Method Enhancement | QA Head |