Elixir Department: SOP for Dispensing Light Sensitive Materials – V 2.0

Posted on By

Elixir Department: SOP for Dispensing Light Sensitive Materials – V 2.0

Standard Operating Procedure for Dispensing Light Sensitive Materials in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/040/2025
Supersedes SOP/ELX/040/2022
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 standardized procedure for the accurate and GMP-compliant dispensing of light-sensitive materials used in the manufacturing of elixir formulations, ensuring protection from light exposure and preserving material integrity.

2. Scope

This SOP is applicable to all light-sensitive raw materials such as ascorbic acid, riboflavin, retinol, and similar ingredients that degrade or lose potency upon exposure to light, used in the Elixir Department.

3. Responsibilities

  • Dispensing Operator:
    • Dispense materials under low-light conditions or using protective shielding.
    • Ensure containers are handled and re-sealed promptly.
  • Warehouse Supervisor:
    • Ensure materials are stored in light-protective containers or amber bottles.
  • QA Officer:
    • Verify that dispensing has occurred under suitable light-protected conditions and approve the release of the material.
See also  Elixir Department: SOP for Dispensing of Raw Materials for Elixirs - V 2.0

4. Accountability

The Production Head and QA Manager are accountable for enforcing and monitoring the dispensing process of light-sensitive materials in accordance with this SOP and applicable regulatory standards.

5. Procedure

5.1 Material Verification

  1. Review the material status on the Material Requisition Form and Batch Manufacturing Record (BMR).
  2. Confirm that the material is labeled “Light Sensitive” and stored in a protective container.
  3. Check for:
    • Intact amber glass/plastic container or opaque cover
    • Proper labeling with batch number and expiry date
    • Green “Approved” status label

5.2 Preparation for Dispensing

  1. Transfer the material to the designated low-light dispensing area.
  2. Cover fluorescent or LED lights with yellow sleeves or switch off unnecessary lights.
  3. Ensure the weighing balance is pre-calibrated and tared with covered containers.

5.3 Dispensing Activity

  1. Minimize the exposure of the material to direct light.
  2. Use light-protective tools and amber-colored or foil-wrapped weighing containers.
  3. Weigh the required quantity as per BMR using covered balance pans.
  4. Immediately transfer dispensed material to amber-colored containers with lids or wrap with aluminum foil.
  5. Label the container and place in a light-shielded storage tray until transferred to production.
See also  Elixir Department: SOP for Handling of Spillage During Dispensing - V 2.0

5.4 Documentation

  1. Record the following in the Material Dispensing Log (Annexure-1):
    • Material Name
    • Batch Number
    • Quantity Dispensed
    • Light Conditions Used
    • Dispensed By / Verified By
  2. Attach the Certificate of Analysis (Annexure-2) and complete the Approval and Release Form (Annexure-3).

5.5 Return and Storage of Excess

  1. Return remaining material to the warehouse immediately in its original light-protected container.
  2. Record returned quantity and verify light-protective measures were maintained.

6. Abbreviations

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

7. Documents

  1. Material Dispensing Log (Annexure-1)
  2. Certificate of Analysis (Annexure-2)
  3. Approval and Release Form (Annexure-3)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice
  • WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products
See also  Elixir Department: SOP for Reconciliation of Raw Materials Post Dispensing - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Dispensing Log

Date Material Batch No. Qty Dispensed Light Conditions Dispensed By Verified By
11/04/2025 Ascorbic Acid AA1234 0.250 kg Yellow Filter Lighting Rajesh Kumar Sunita Reddy

Annexure-2: Certificate of Analysis (CoA)

Material Batch No. Test Result Status
Ascorbic Acid AA1234 Assay 99.8% Complies

Annexure-3: Approval and Release Form

Date Material Batch No. Released By Approved By Remarks
11/04/2025 Ascorbic Acid AA1234 Ajay Mehta Manoj Verma Approved for Light-Sensitive Handling

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release Document Creation QA Head
11/04/2025 2.0 Added Environmental Controls and Light Handling Criteria Audit Update QA Head
Elixers V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,