Standard Operating Procedure for Odor Check During Final Blending in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/195/2025
Supersedes	SOP/ELX/195/2022
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 standard procedure for evaluating the odor of elixirs during the final blending stage to ensure product organoleptic quality, consistency, and consumer acceptability.

2. Scope

This SOP applies to all elixir products that require odor assessment as part of in-process quality checks during the final blending stage prior to filtration and packing.

3. Responsibilities

• Production Operator:
  • Collect the sample for odor check at the final blending stage and notify QA.
• QA Officer:
  • Perform and document odor evaluation and compare it with the approved specification.
• QC Analyst:
  • Assist in odor profiling during product development and maintain reference standards.

4. Accountability

The Production Head is accountable for ensuring samples are submitted for odor testing at the correct stage. QA is accountable for final product release based on odor compliance.

5. Procedure

5.1 Sampling for Odor Evaluation

1. Collect a 50–100 mL sample from the final blended batch before filtration.
2. Use clean, dry, odor-neutral glass containers with air-tight closures.
3. Label with product name, batch number, date, and “Odor Evaluation Sample.”
4. Transport immediately to the designated organoleptic testing zone or QA office.

5.2 Odor Check Method

1. Ensure the room is free of distracting smells or aromatic substances.
2. Open the container and allow it to stand for 30 seconds before evaluation.
3. Hold the container 5–10 cm away from the nose and inhale gently.
4. Evaluate the odor based on:
   • Characteristic aroma (e.g., fruity, minty, herbal)
   • Absence of off-odors (e.g., sour, rancid, chemical)
   • Strength and uniformity
5. If multiple assessors are involved, ensure consistency and document all findings.

5.3 Acceptance Criteria

1. Odor must match the approved organoleptic profile described in the product specification or development report.
2. No foreign, unexpected, or off-putting smells shall be present.
3. If odor is marginal or doubtful, repeat the test and consult QC and Product Development for guidance.

5.4 Documentation

1. Record observations in the Odor Evaluation Logbook (Annexure-1).
2. Include date, batch number, evaluator’s name, descriptor used, result (Accepted/Rejected), and QA remarks.
3. Any deviation must be reported immediately and the batch held for investigation.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control

7. Documents

1. Odor Evaluation Logbook (Annexure-1)
2. Product Specification Sheet
3. BMR (Batch Manufacturing Record)

8. References

• ICH Q6A – Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and Products
• WHO TRS 986 – GMP Guidelines
• 21 CFR Part 211 – Subpart F: Production and Process 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: Odor Evaluation Logbook

Date	Batch No.	Evaluator	Odor Description	Result	QA Remarks
11/04/2025	ELX-0425-014	Rajesh Kumar	Minty and Sweet – No Off Odor	Accepted	Matches Reference

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 controlled environment and reference standard procedure	Process Standardization	QA Head