Standard Operating Procedure for Color and Odor Testing of Elixir Formulations
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/221/2025 |
| Supersedes | SOP/ELX/221/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To describe the procedure for evaluating the color and odor of elixir formulations during in-process checks and final product release to ensure consistency with approved specifications and organoleptic properties.
2. Scope
This SOP is applicable to the Quality Control Department for assessing the color and odor of elixir products as part of routine quality evaluation.
3. Responsibilities
- QC Analyst:
- Perform the organoleptic evaluation and record observations accurately.
- QC Supervisor:
- Verify the observations and compare against reference standards or historical data.
- QA Officer:
- Ensure specifications are met and results are reviewed prior to batch release.
4. Accountability
The QC Head is accountable for ensuring accurate execution of this SOP. The QA Head is responsible for ensuring organoleptic consistency and final batch disposition.
5. Procedure
5.1 Sample Preparation
- Take a representative sample of the
elixir (approx. 20–30 mL).
Use a clean, transparent glass container with a wide opening.
Ensure the sample is at room temperature (25 ± 2°C).
5.2 Color Evaluation
- Observe the sample in natural or white light against a white background.
- Compare with the product specification or reference standard (if available).
- Note any deviation from expected appearance:
- Color change (e.g., darkening, fading, precipitation)
- Presence of haze or turbidity
- Record the color as per the descriptor (e.g., transparent pink, amber, clear green).
5.3 Odor Evaluation
- Immediately after removing the cap, gently waft air above the container toward your nose (do not inhale directly).
- Assess for:
- Characteristic aroma as defined in formulation (e.g., minty, fruity, alcoholic)
- Any off-odors (e.g., rancid, sulfurous, medicinal)
- If off-odor is suspected, have a second analyst confirm and report to supervisor.
5.4 Acceptance Criteria
- Color: Should match the specification or approved reference standard for that formulation.
- Odor: Should be acceptable, pleasant, and characteristic of the flavoring agent used.
- Any deviation must be documented and investigated as per deviation SOP.
5.5 Documentation
- Record observations in the Color and Odor Evaluation Logbook (Annexure-1).
- Include batch number, product name, date, result, and analyst signature.
6. Abbreviations
- SOP: Standard Operating Procedure
- QC: Quality Control
- QA: Quality Assurance
7. Documents
- Color and Odor Evaluation Logbook (Annexure-1)
- Reference Standard Register (if applicable)
- Batch Manufacturing Record (BMR)
8. References
- 21 CFR Part 211.160 – Laboratory Controls
- ICH Q6A – Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and 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: Color and Odor Evaluation Logbook
| Date | Batch No. | Color Observed | Odor Observed | Specification Match | Tested By | Verified By |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-0425-039 | Clear pale pink | Fruity | Yes | 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 | Clarified evaluation descriptors and documentation fields | GMP Enhancement | QA Head |