Elixir Department: SOP for Light Protection Measures in Manufacturing – V 2.0

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Elixir Department: SOP for Light Protection Measures in Manufacturing – V 2.0

Standard Operating Procedure for Light Protection Measures in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/118/2025
Supersedes SOP/ELX/118/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a standard procedure for implementing light protection measures during manufacturing, handling, and storage of light-sensitive elixir products in order to maintain product stability, potency, and regulatory compliance.

2. Scope

This SOP applies to all light-sensitive formulations and raw materials handled in the Elixir Department from dispensing to packaging, including batch manufacturing, intermediate holding, sampling, and in-process storage.

3. Responsibilities

  • Production Operator:
    • Use amber containers and cover vessels as per instructions.
    • Ensure protective coverings are intact during manufacturing steps.
  • Production Supervisor:
    • Verify light protection measures at each stage of the process.
    • Ensure correct labels are affixed on light-sensitive products and containers.
  • QA Officer:
    • Conduct checks during batch verification for light-protection compliance.
    • Review deviation reports in case of accidental light exposure.

4. Accountability

The Head of Production is accountable for implementing and maintaining light protection measures during manufacturing and ensuring compliance with this SOP.

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5. Procedure

5.1 Identification of Light-Sensitive Products

  1. Refer to the Master Formula Record (MFR) to identify products or ingredients requiring light protection.
  2. Ensure such materials are marked in the batch manufacturing record (BMR) as “LIGHT-SENSITIVE.”
  3. Verify raw material packaging is amber-colored or wrapped in protective film.

5.2 Environment and Lighting Controls

  1. Conduct all processing of light-sensitive materials under low-lux yellow lighting or in a designated low-light processing area.
  2. Ensure that windows and skylights are covered with UV-protective films or curtains.
  3. Use blackout panels or screens where applicable.

5.3 Equipment and Container Requirements

  1. Use amber glass or high-density polyethylene (HDPE) containers for storage and transfer of light-sensitive solutions.
  2. If transparent containers are used temporarily, wrap them with aluminum foil or light-resistant covers.
  3. Ensure that sample containers and intermediate holding vessels are similarly protected.

5.4 Manufacturing Operations

  1. Perform all weighing, dispensing, mixing, and sampling in shaded or light-protected areas.
  2. Minimize exposure time to ambient lighting during transfer and filling operations.
  3. Seal vessels quickly and ensure lids or protective covers are used during every step.
  4. Do not open light-sensitive containers unless required; reseal immediately after use.
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5.5 Labeling and Identification

  1. Affix “LIGHT-SENSITIVE” warning labels on all intermediate and final containers.
  2. Include storage instructions such as “Store in amber bottle at 25°C, protected from light” on batch documentation and product label.

5.6 In-Process Storage and Transfer

  1. Place materials under UV-protective covers when transferring from one area to another.
  2. Use closed trolleys or dark-colored bins for transportation within the facility.
  3. Avoid delays in transfer that can prolong light exposure.

5.7 Deviation Handling

  1. If unintentional light exposure occurs:
    • Record incident immediately.
    • Hold material under quarantine.
    • Initiate a deviation form and impact assessment by QA.
  2. Decide batch disposition based on analytical data and QA review.

5.8 Documentation and Verification

  1. Record light protection measures in the Light Protection Log (Annexure-1).
  2. QA to verify compliance during in-process checks and at batch review stage.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • BMR: Batch Manufacturing Record
  • MFR: Master Formula Record
  • QA: Quality Assurance

7. Documents

  1. Light Protection Log (Annexure-1)
  2. Deviation Form (if applicable)
  3. Batch Manufacturing Record (BMR)

8. References

  • ICH Q1B – Photostability Testing of New Drug Substances and Products
  • WHO TRS 1010 – GMP Guidelines
  • 21 CFR Part 211 – Current Good Manufacturing Practices

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Light Protection Log

Date Batch No. Area Container Type Protection Used Operator Verified By (QA)
11/04/2025 ELX-1052 Dispensing Room Amber Bottle Aluminum Foil Wrap 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 Added handling during transfer and deviation management GMP Enhancement QA Head
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