SOP Guide for Pharma

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

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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.

See also  Elixir Department: SOP for Cleaning Flammable Solvent Equipment - V 2.0

5. Procedure

5.1 Inspection Setup

  1. 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

    1. 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

    1. Pour the sample into a transparent glass vial up to 2/3 of its capacity.
    2. Hold the vial between light source and background panel for inspection.
    3. 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
    4. Rotate gently and observe for consistency of appearance.
    5. If any deviation is noted, immediately report to QA and halt further processing.

    5.4 Comparison with Reference Standards

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

    5.5 Acceptance Criteria

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

    5.6 Documentation

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

    6. Abbreviations

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

    7. Documents

    1. Appearance and Color Check Logbook (Annexure-1)
    2. 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
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