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.
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
- Review the material status on the Material Requisition Form and Batch Manufacturing Record (BMR).
- Confirm that the material is labeled “Light Sensitive” and stored in a protective container.
- 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
- Transfer the material to the designated low-light dispensing area.
- Cover fluorescent or LED lights with yellow sleeves or switch off unnecessary lights.
- Ensure the weighing balance is pre-calibrated and tared with covered containers.
5.3 Dispensing Activity
- Minimize the exposure of the material to direct light.
- Use light-protective tools and amber-colored or foil-wrapped weighing containers.
- Weigh the required quantity as per BMR using covered balance pans.
- Immediately transfer dispensed material to amber-colored containers with lids or wrap with aluminum foil.
- Label the container and place in a light-shielded storage tray until transferred to production.
5.4 Documentation
- Record the following in the Material Dispensing Log (Annexure-1):
- Material Name
- Batch Number
- Quantity Dispensed
- Light Conditions Used
- Dispensed By / Verified By
- Attach the Certificate of Analysis (Annexure-2) and complete the Approval and Release Form (Annexure-3).
5.5 Return and Storage of Excess
- Return remaining material to the warehouse immediately in its original light-protected container.
- 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
- Material Dispensing Log (Annexure-1)
- Certificate of Analysis (Annexure-2)
- 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
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 |