Standard Operating Procedure for Transfer of Dispensed Materials to Manufacturing Area
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/052/2025 |
| Supersedes | SOP/ELX/052/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To describe the procedure for safe, traceable, and compliant transfer of dispensed raw materials, excipients, and solvents from the dispensing area to the designated elixir manufacturing area.
2. Scope
This SOP is applicable to all dispensed materials transferred for elixir batch production, including APIs, sweeteners, flavors, preservatives, and vehicles, in the Elixir Department.
3. Responsibilities
- Dispensing Operator:
- Label and prepare materials for transfer as per BMR.
- Ensure appropriate documentation accompanies each transfer.
- Production Operator:
- Receive and verify dispensed materials as per the Material Transfer Record.
- QA Officer:
- Verify the transfer process and sign the release for manufacturing use.
4. Accountability
The Production Head is accountable for ensuring materials are transferred securely and without deviation from SOP or BMR instructions.
5. Procedure
5.1 Pre-Transfer Preparation
- Ensure the materials are dispensed as
per approved BMR and labeled with:
Check that containers are sealed properly and not damaged or leaking.
- Material Name
- Batch Number
- Dispensed Quantity
- Container Number
- Status: “Approved for Manufacturing”
5.2 Documentation for Transfer
- Attach the following documents:
- Material Transfer Record (Annexure-1)
- Copy of Material Dispensing Log
- Copy of BMR page indicating material requirement
5.3 Transfer Process
- Transfer materials in clean, dedicated trolleys with proper labels (e.g., “Materials for Batch ELX-001”).
- Ensure movement through designated pathways avoiding any mix-ups or exposure to open areas.
- Use dynamic pass box if moving between classified zones.
5.4 Receipt and Verification
- Manufacturing personnel shall check:
- Material name and batch number
- Container integrity and labeling
- Quantity and container sequence
- Record receipt in the Material Receipt Log (Annexure-2) and get it verified by QA.
5.5 Storage Until Use
- Store transferred materials in the designated material holding area within the manufacturing room.
- Ensure containers are not stacked beyond two levels and are placed on stainless steel pallets.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
7. Documents
- Material Transfer Record (Annexure-1)
- Material Receipt Log (Annexure-2)
- Material Label Verification Checklist (Annexure-3)
8. References
- WHO GMP Guidelines – Movement of Materials
- 21 CFR 211.80 – Handling of Raw Materials
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 Transfer Record
| Date | Material Name | Batch No. | Qty | Container No. | Transferred By | Verified By |
|---|---|---|---|---|---|---|
| 11/04/2025 | Sorbitol Solution | SB2201 | 10.0 L | 1 of 1 | Rajesh Kumar | Sunita Reddy |
Annexure-2: Material Receipt Log
| Date | Batch ID | Material | Qty | Received By | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | ELX-001 | Sorbitol Solution | 10.0 L | Manoj Nair | OK |
Annexure-3: Material Label Verification Checklist
| Item | Status (Yes/No) | Verified By |
|---|---|---|
| Correct Material Name | Yes | Sunita Reddy |
| Batch Number Matches Dispensing Record | Yes | Sunita Reddy |
| Container Intact and Sealed | Yes | 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 Label Checklist and Updated Flow | Regulatory Compliance | QA Head |