Elixir Department: SOP for Appearance and Color Check – V 2.0

Standard Operating Procedure for Appearance and Color Check in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/194/2025
Supersedes	SOP/ELX/194/2022
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 a standardized procedure for conducting appearance and color checks during elixir manufacturing to ensure visual quality, detect abnormalities, and verify conformance with approved specifications.

2. Scope

This SOP applies to all in-process and final product appearance and color assessments conducted within the Elixir Manufacturing Department, including visual inspection under controlled lighting.

3. Responsibilities

Production Operator:
- Perform visual checks at defined stages and report abnormalities.
QA Officer:
- Verify that appearance and color conform to specifications.
QC Analyst:
- Compare samples against approved reference standards or visual charts.

4. Accountability

The Production Head is accountable for implementing this SOP. QA ensures adherence and documentation review, while QC is responsible for reference standard maintenance and comparative analysis.

5. Procedure

5.1 Inspection Setup

Perform all appearance and color checks in a clean, dust-free area with

standardized illumination (e.g., D65 daylight lamp or equivalent white light source).

Use white and black background panels to assess clarity, sediment, and transparency.

Ensure the sample container is clean, dry, and free of fingerprints or residues.

5.2 Sampling Points

Appearance and color checks shall be performed at the following stages:
- Post addition of colorant
- Post complete mixing
- Post filtration
- Final bulk stage (before filling)

5.3 Visual Assessment Procedure

Pour the sample into a transparent glass vial up to 2/3 of its capacity.
Hold the vial between light source and background panel for inspection.
Check for the following:
- Color: Should match approved visual standard or specification range
- Clarity: Should be clear or as per defined specification
- Presence of foreign particles, fibers, sediment, or haze
Rotate gently and observe for consistency of appearance.
If any deviation is noted, immediately report to QA and halt further processing.

5.4 Comparison with Reference Standards

QC shall maintain color and appearance standards for each product batch.
Use retained samples or color shade cards validated by product development.
Comparisons should be done side-by-side under identical lighting and background conditions.

5.5 Acceptance Criteria

Appearance: Must conform to description in product specification (e.g., “clear reddish-brown liquid, free from visible particles”).
Color: Must be within ± one shade of the approved standard unless otherwise justified in development report.

5.6 Documentation

Record all observations in the Appearance and Color Check Logbook (Annexure-1).
Document date, batch number, stage, result, and reviewer signature.

6. Abbreviations

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

7. Documents

Appearance and Color Check Logbook (Annexure-1)
Approved Reference Standards File

8. References

21 CFR Part 211.110 – In-process Materials Testing
ICH Q6A – Specifications: Test Procedures and Acceptance Criteria
WHO TRS 986 – GMP for Pharmaceuticals

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 Color Check Logbook

Date	Batch No.	Stage	Appearance	Color	Checked By	QA Verified
11/04/2025	ELX-0425-013	Post Filtration	Clear, No Particulates	Light Yellow (Matched)	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	Added shade comparison and revised acceptance criteria	Visual QA Standardization	QA Head