SOP Guide for Pharma

Elixir Department: SOP for Addition of Color Solutions – V 2.0

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Elixir Department: SOP for Addition of Color Solutions – V 2.0

Standard Operating Procedure for Addition of Color Solutions in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/088/2025
Supersedes SOP/ELX/088/2022
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 the procedure for the controlled addition of permitted color solutions during the manufacturing of elixirs, ensuring product consistency, safety, and regulatory compliance.

2. Scope

This SOP applies to all batches of elixir products where colorants are used for aesthetic or identification purposes in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Weigh, dissolve, and add color solutions as per batch manufacturing record (BMR).
    • Ensure homogeneous mixing and proper labeling of containers.
  • Production Supervisor:
    • Verify correct colorant, quantity, and process timing.
    • Authorize addition based on stage completion.
  • QA Officer:
    • Review BMR entries and validate the correct use of approved colorants.

See also  Elixir Department: SOP for Water Content Determination (Karl Fischer) - V 2.0

4. Accountability

The Head of Production is accountable for ensuring color solutions are added under controlled conditions and documented accurately.

5. Procedure

5.1 Selection of Colorants

  1. Use only colors approved by regulatory authorities
such as CDSCO, US FDA, or as per Schedule Q of Drugs and Cosmetics Rules (India).
  • Verify that the correct color name, batch number, and expiry are mentioned in the BMR.
  • Colorants must be stored in designated areas away from APIs and excipients.

    • 5.2 Preparation of Color Solution

    1. Wear appropriate PPE and operate under a laminar flow unit if required.
    2. Weigh the specified amount of colorant on a calibrated balance.
    3. Dissolve the colorant in pre-measured quantity of purified water or suitable solvent as mentioned in the BMR.
    4. Filter the solution through a 0.2 mm mesh stainless steel sieve before use.

    5.3 Addition to the Batch

    1. Confirm that all prior batch manufacturing steps (e.g., API dissolution, pH adjustment) are completed.
    2. Slowly add the prepared color solution into the main batch under continuous stirring to ensure uniform distribution.
    3. Monitor visual appearance and check for homogeneity.

    5.4 Documentation

    1. Record colorant name, batch number, quantity used, solvent, and time of addition in the BMR and Color Addition Log (Annexure-1).
    2. Ensure both operator and supervisor sign off on the activity.

    5.5 Special Precautions

    1. Do not use expired or non-approved colorants.
    2. Avoid over-addition. If reprocessing is required, escalate to QA immediately.
    3. Colorant containers should be handled with clean gloves and closed immediately after use.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • BMR: Batch Manufacturing Record
    • QA: Quality Assurance
    • CDSCO: Central Drugs Standard Control Organization
    • PPE: Personal Protective Equipment

    7. Documents

    1. Color Addition Log (Annexure-1)
    2. BMR (Color Addition Section)
    3. COA of Colorant (Annexure-2)

    8. References

    • Schedule Q – Drugs and Cosmetics Rules, India
    • 21 CFR Part 74 – Listing of Color Additives Subject to Certification
    • ICH Q7 – GMP for APIs

    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 Addition Log

    Date Batch No. Color Used Quantity (mg) Diluent Added By Verified By
    11/04/2025 ELX-1027 Sunset Yellow FCF 150 mg Purified Water Rajesh Kumar Sunita Reddy

    Annexure-2: Certificate of Analysis (CoA) for Colorant

    Colorant Name Batch No. Test Performed Result Status
    Sunset Yellow FCF SY-2205 Identification, Purity, Microbial Limit Complies Approved

    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 Added color solution filtration step and CoA tracking Process Improvement QA Head
    See also  Elixir Department: SOP for Documentation in Manufacturing Logbooks - V 2.0
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